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348 essais correspondent à votre recherche

Fiche détaillée de l'essai

Acronyme : GRAALL 2014
Spécialité : Hématologie
Traitement : Autres
Ouvert aux inclusions : Oui

(Cliquer sur détails pour connaitre les centres)

Phase(s) : Phase II, Phase III
Descriptif

 - 

Informations

Phase: 2, 3


Promoteur: Assistance Publique, Hôpitaux de Paris - http://www.aphp.fr/
Autre(s) acronyme(s): NR
Contact promoteur: Project Referent : Cathia TOROMANOFF


Mail promoteur: cathia.toromanoff@drc.aphp.fr
Tel promoteur: Tel: +33 (0)1 40 27 52 61
Coordonnateur: Pr. Hervé DOMBRET
Clinical research coordinator:Lakhdar MAMERI

Mail coordonnateur: Email: herve.dombret@sls.aphp.fr

Email: lakhdar.mameri@paris7.jussieu.fr
Tel Coordonnateur: Coordinator: Tel: +33 (0)1 57 27 68 47 /(0)1 42 49 96 48
Clinical research coordinator: Tel: +33 (0)1 42 38 53 20
Fax: +33 (0)1 42 49 97 45
-
Source: NR"

Cet essai dans d'autres annuaires :

Titre :

Multicenter trial for the treatment of Acute Lymphoblastic Leukemia (ALL) in younger adults (18-59 years).

Critères d'inclusion :

Le protocole GRAALL-2014 est subdivisé en 3 sous études. Vous pouvez accéder à plus de détails en cliquant sur les liens

GRAALL -2014 /B  (LAL de la lignée B Ph -)

GRAALL -2014/ T et ATRIALL (LAL T) 

GRAAPH -2014 ( LAL Ph +)

Critères de non-inclusion :
Centres investigateurs

Centres participants à l'essai Contact investigateur Contact TEC/IRC Patients inclus/à inclure Ouverts aux inclusions Maj
Brest - CHU de Brest - Site Morvan Dr Guillerm - NICOLAS Isabelle - 4 / nc Oui 18/06/2018
Rennes - CHU de Rennes - Site Hôpital Pontchaillou Dr Martine Escoffre-Barbe - Hayat Djelti - hayat.djelti@chu-rennes.fr 18 / 30 Oui 19/02/2019
Afficher les détails
Acronyme : aXa
Spécialité : Autres
Traitement : Autres
Ouvert aux inclusions : Oui

(Cliquer sur détails pour connaitre les centres)

Phase(s) : Phase III
Descriptif

Il s’agit d’une étude prospective multicentrique (11 centres) avec :
- une étude de cohorte de 200 sujets hospitalisés pour MVTE et ayant un cancer
(suivis pendant 6 mois).
- une étude comparative de la pharmacocinétique de l’activité anti-Xa entre les 50
premiers sujets (de la cohorte) hospitalisés pour MVTE et ayant un cancer, et 50
sujets hospitalisés pour MVTE et indemnes de cancer, appariés (1-1) pour l’âge, la
fonction rénale et le sexe.

Informations

Phase: 3
Promoteur: A P - HÔPITAUX DE PARIS
Autre(s) acronyme(s): P100127
Contact promoteur: Nathalie Authesserre-Tachet, APHP
Mail promoteur: NR
Tel promoteur: NR
Coordonnateur: Pr. Guy Meyer, Hôpital Européen Georges Pompidou
Mail coordonnateur: NR
Tel Coordonnateur: NR
-
Source: Version N°6.0 du 19/12/2013

Titre :

Activité anti Xa chez les sujets atteints de cancers traités par héparine de bas poids moléculaire pour maladie veineuse thromboembolique (aXa).

Critères d'inclusion :
  • Patient hospitalisé pour MVTE

  • Traitement initial par une HBPM ou fondaparinux

  • Patient majeur

  • Affiliation à un régime de sécurité sociale

  • Consentement éclairé écrit

    Pour les cancéreux :

  • Cancer solide en évolution (maladie tumorale active ou résection tumorale incomplète ou marqueurs tumoraux restés élevés après résection complète).

  • Traitement par tinzaparine à dose curative.

    Pour les non cancéreux :

  • absence de pathologie tumorale maligne décelable à l’inclusion

Critères de non-inclusion :
  • Contre-indication au traitement curatif par HBPM

  • Traitement initial par une molécule anticoagulante autre qu’une HBPM ou du fondaparinux ( antithrombine directe, inactivateur direct du facteur Xa)

  • Insuffisance rénale (clairance à la créatinine < 30 ml/min)

  • Patient préalablement inclus dans l’étude

  • Grossesse, allaitement

  • Patient dont le poids est supérieur à 100 Kg

    Pour les cancéreux :

  • Maladie tumorale non confirmée histologiquement ou cytologiquement.

  • Suivi après résection tumorale complète sans élévation des marqueurs tumoraux

  • Espérance de vie < 6 mois

  • Suivi impossible

    Pour les non cancéreux :

  • Suspicion non encore confirmée de pathologie tumorale maligne associée à la MVTE.

Centres investigateurs

Centres participants à l'essai Contact investigateur Contact TEC/IRC Patients inclus/à inclure Ouverts aux inclusions Maj
Brest - CHU de Brest - Site La Cavale Blanche Pr. F. Couturaud - francis.couturaud@chu-brest.fr Sophie Barillot - sophie.barillot@chu-brest.fr / Oui 23/04/2014
Afficher les détails
Acronyme : ALXN1210-PNH-201 2015-002674-20
Spécialité : Hématologie
Traitement : Autres
Ouvert aux inclusions : Oui

(Cliquer sur détails pour connaitre les centres)

Phase(s) : Phase II
Descriptif
  • Biological: Study Drug- ALXN1210
    Cohort 1: ascending dose escalation to therapeutic dose level
  • Biological: Study Drug- ALXN1210
    Cohort 2: ascending dose escalation to therapeutic dose level
  • Biological: Study Drug- ALXN1210
    Cohort 3: ascending dose escalation to therapeutic dose level
Informations

Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

n° NCT02605993
Rennes, France, 35000
Contact PROMOTEUR: Alexion Pharmaceuticals       clinicaltrials@alxn.com

 

Cet essai dans d'autres annuaires :

Titre :

A Phase 2, Open-label, Multiple Ascending Dose Study to Evaluate the Efficacy, Safety, Tolerability, Immunogenicity, Pharmacokinetics, and Pharmacodynamics of ALXN1210 Administered Intravenously to Patients With Paroxysmal Nocturnal Hemoglobinuria

Critères d'inclusion :
  1. Male or female ≥ 18 years of age
  2. PNH diagnosis confirmed by documented high-sensitivity flow cytometry
  3. Documented meningococcal vaccination not more than 3 years prior to dosing
  4. Female patients of childbearing potential must use highly effective contraception starting at screening and continuing until at least 6 months after the last dose of ALXN1210.
  5. Willing and able to give written informed consent and comply with the study visit schedule
Critères de non-inclusion :
  1. Treatment with a complement inhibitor at any time
  2. Females who are pregnant, breastfeeding or who have a positive pregnancy test at screening or Day 1
  3. Participation in a clinical study within 30 days before initiation of dosing o Day 1, or use of any experimental therapy within 30 days prior to dosing on Day, or within 5 half lives of the product, whichever is greater
  4. History of allergy to excipients of ALXN1210 or known allergy to Chinese hamster ovary (CHO) cell proteins
  5. Inability to comply with study requirements
  6. History of any clinically significant cardiac, hepatic, immunologic, pulmonary, or rheumatoid disease that, in the Investigator's judgment, would preclude participation
  7. Other unspecified reasons that, in the opinion of the Investigator or Sponsor, make the patient unsuitable for enrollment
Centres investigateurs

Centres participants à l'essai Contact investigateur Contact TEC/IRC Patients inclus/à inclure Ouverts aux inclusions Maj
Brest - CHU de Brest - Site Morvan Dr Eveillard - Guillaume Drugmanne - guillaume.drugmanne@chu-brest.fr 0 / 2 Oui 18/06/2018
Rennes - CHU de Rennes - Site Hôpital Pontchaillou Dr Sophie De Guibert - Hayat Djelti - hayat.djelti@chu-rennes.fr 1 / 1 Non 20/02/2018
Afficher les détails
Acronyme : CARADERM NI_2014_60
Spécialité : Dermatologie
Traitement : Autres
Ouvert aux inclusions : Oui

(Cliquer sur détails pour connaitre les centres)

Phase(s) : Sans phase
Descriptif

"CARADERM is a French national multidisciplinary project which will prospectively enroll from 37 French centers any patient presenting with Merkel cell carcinoma, advanced basal cell carcinoma requiring systemic treatment or cutaneous adnexal carcinoma.
A structured and centralized database of clinical monitoring of patients will be established. Information captured will include clinical constitutional factors, factors linked to primary carcinoma, factors linked to lymph node involvement, ""American Joint Committee on Cancer"" (AJCC) stage at inclusion, recurrence patterns, therapeutic interventions (medical, surgical, radiotherapy and palliative strategies) with evaluation of response, date of death, date of latest news."

Informations

Base de données nationale

Adnexal Tumor of Skin
Merkel Cell Carcinoma
Advanced Basal Cell Carcinoma Requiring Systemic Treatment"

Promoteur: University Hospital, Lille
Autre(s) acronyme(s): NI_2014_60
Contact promoteur:
Contact: Benoit Minart
Mail promoteur: laurent.mortier@chru-lille.fr
benoit.minart@chru-lille.fr
Tel promoteur: 03.20.44.41.93 ext +33
nc
Coordonnateur: Contact: Laurent MORTIER, MD,PhD

-
Source: Clinicaltrials.org 11/10/2017"

Cet essai dans d'autres annuaires :

Titre :

"French National Database of Rare Dermatological Cancers: Merkel Cell Carcinoma, Inoperable or Metastatic Basal Cell Carcinoma, Cutaneous Adnexal Carcinomas "

Critères d'inclusion :
  1. Patients with histologically confirmed Merkel cell carcinoma, advanced basal cell carcinoma requiring systemic treatment, or cutaneous adnexal carcinoma
Critères de non-inclusion :
  1. "Subjects without Merkel cell carcinoma, advanced basal cell carcinoma requiring systemic treatment, or cutaneous adnexal carcinoma

  2. Patients refusal"

Centres investigateurs

Centres participants à l'essai Contact investigateur Contact TEC/IRC Patients inclus/à inclure Ouverts aux inclusions Maj
Rennes - CHU de Rennes - Site Hôpital Pontchaillou Pr Dupuy - Alain.DUPUY@chu-rennes.fr UIC - 12 / 20 Oui 10/10/2017
Afficher les détails
Acronyme : LIP-RE- NCT01126463
Spécialité : Hépatologie
Traitement : Autres traitements exclusifs
Ouvert aux inclusions : Oui

(Cliquer sur détails pour connaitre les centres)

Phase(s) : Phase I
Descriptif

Experimental: Rhenium Lipiodol
Hepatic Intra-Arterial Administration of radio-active lipiodol.
Intervention: Drug: 188Re-SSS Lipiodol

Informations

Carcinome hépatocellulaire

Phase: 1

Promoteur: Center Eugene Marquis
Autre(s) acronyme(s): NCT01126463
Contact promoteur: Oussama ZEKRI, PhD
Mail promoteur: 33/299253132
Tel promoteur: o.zekri@rennes.fnclcc.fr
Coordonnateur: Etienne GARIN, MD, PhD
Mail coordonnateur: e.garin@rennes.fnclcc.fr
Tel Coordonnateur: 33/299253088
-
Source: Clinical Trial"


site internet : http://www.centre-eugene-marquis.fr/

Source des informations sur le protocole :Registre de l'INCA du 22 Mai 2013

Cet essai dans d'autres annuaires :

Titre :

Administration intra-artérielle hépatique de 188Re-SSS-lipiodol dans les carcinomes hépatocellulaires : étude de phase I

Critères d'inclusion :
  1. Age ≥ 18 ans.

  2. Carcinome hépatocellulaire avancé histologiquement ou cytologiquement prouvé, ou association tumeur du foie sur hépatopathie chronique et AFP > 400 ng/mL, ou formation tumorale hépatique considérée comme hypervascularisée par au moins 2 techniques d’imagerie chez un patient cirrhotique.

  3. Tumeur non opérable, non résécable, non transplantable, non accessible à un traitement percutané.

  4. Tumeur mesurable, uni- ou multinodulaire, occupant moins de 50% du volume hépatique.

  5. Stade C ou D BCLC (ou stade 0 à 3 du CLIP).

  6. Indice de performance ≤ 2 (OMS).

  7. Données hématologiques : polynucléaires neutrophiles ≥ 1,5 x 109/L, plaquettes ≥ 50 x 109/L.,

  8. Facteurs de coagulation : taux de prothrombine ≥ 40% (INR≤ 2,3).

  9. Fonction rénale : clairance de la créatinine ≥ 55 mL/min.

  10. Possibilité de traitement par radiothérapie intra-artérielle sur décision d'une Réunion de Concertation Pluridisciplinaire.

  11. Contraception efficace pour les femmes en âge de procréer.

  12. Consentement éclairé signé

Critères de non-inclusion :

Amendement MARS 2016 = nouveau critère d'exclusion: Patient présentant un shunt pulmonaire > 20%]

  1.  État correspondant à une toxicité de grade 3 (CTCAE v 4).

  2.  Hépatocarcinome de classe III (Okuda).

  3.  Encéphalopathie avec troubles mêmes modérés de la conscience.

  4.  Insuffisance respiratoire chronique évoluée quelle qu'en soit l'origine (avec signes cliniques d'insuffisance respiratoire).

  5.  Contre-indication liée à la technique, notamment pathologie artérielle sévère des membres inférieurs ou de l'aorte contre-indiquant ou rendant difficile une artériographie par voie fémorale.

  6.  Patient dépendant d'une tierce personne pour les soins quotidiens (radioprotection de l'équipe).

  7.  Incontinence urinaire.

  8.  Autre cancer évolutif.

  9.  Femme enceinte ou allaitant

Centres investigateurs

Centres participants à l'essai Contact investigateur Contact TEC/IRC Patients inclus/à inclure Ouverts aux inclusions Maj
Rennes - Centre Eugène Marquis Pr Etienne Garin - Aurélie Sauvanet - a.sauvanet@rennes.unicancer.fr NC / NC Oui 29/01/2018
Plate-Forme D'Essais Précoces - - NC / NC Oui 26/06/2013
Rennes - CLIP² Dr Thierry Lesimple - Damien Denis - damien.denis@chu-rennes.fr / Oui 24/02/2016
Afficher les détails
Acronyme : AcSé Nivo Acsé Nivolumab AcSé NIVO UC0105/1611
Spécialité : Autres
Traitement : Autres traitements exclusifs
Ouvert aux inclusions : Oui

(Cliquer sur détails pour connaitre les centres)

Phase(s) : Phase II
Descriptif

"Experimental: Nivolumab

Nivolumab 240 mg IV over 60 minutes every 14 days.
Intervention: Drug: Nivolumab"

Informations
Cancer rare localement avancé ou métastatique ou réfractaire, inopérable
toutes lignes

Cohort 1: Non-clear cell RCC FERMEE 05/02/2019
Cohort 2: Rare head and neck cancer FERMEE 26/08/2019
Cohort 3: Rare skin cancer OUVERTE 05/02/2018
Cohort 4: MSI-nonCRC FERMEE 31/10/2018
Cohort 5: Penile cancer OUVERTE

Cohorte 6 : any non MSI-high cancer OUVERTE

Phase: 2

Promoteur: Centre Eugène Marquis
Autre(s) acronyme(s): Acsé Nivolumab AcSéNIVO-T. Solides UC0105/1611
Contact promoteur: Daniel Couch +fr

Mail promoteur: d-couch@unicancer.fr
Tel promoteur: +33 (0)1 80 50 12 96
Coordonnateur: Jean-Charles Soria, Prof. MD

Mail coordonnateur: jean-charles.soria@gustaveroussy.fr
Tel Coordonnateur: NR
-
Source: linicaltrials.org 03/08/2017"

Cet essai dans d'autres annuaires :

Titre :

Secured Access to Nivolumab for Adult Patients With Selected Rare Cancer Types

Critères d'inclusion :
 
  1. "Patient information sheet and written informed consent form signed.

  2. Histologically confirmed diagnosis of a pathology corresponding to one of the following selected cancer types:

  3. Non-clear cell renal-cell carcinomas: papillary renal cell carcinoma (pRCC, type I, type II and non-classified pRCC), chromophobe RCC (ChRCC), renal medullary carcinoma (RMC), collecting duct/Bellini duct carcinoma (CDC), microphthalmia-associated transcription (MiT) family translocation renal cell carcinoma (tRCC), renal cell carcinoma with a prominent sarcomatoid component (sarcRCC).

  4. Rare head and neck cancers: principal and accessory salivary gland tumours, facial tissue tumours.

  5. Rare skin cancers: adnexal carcinomas, basal cell carcinoma resistant to vismodegib.

  6. Non-colorectal cancers with microsatellite instability determined locally by immunohistochemistry or polymerase chain-reaction (PCR)

  7. Squamous cell carcinoma of penis.

  8. Metastatic disease or unresectable locally advanced malignancy that is resistant or refractory to standard therapy or for which standard therapy does not exist or is not considered appropriate by the Investigator.

  9. Aged ≥ 18 years old.

  10. Measurable disease according to RECIST v1.1 guidelines for solid tumours (Eisenhauer, 2009).

  11. Able to provide a formalin fixed/paraffin embedded (FFP)E biopsy sample of a metastatic site or primitive tumour tissue.

  12. Note: Patients for whom suitable archived biopsy material is not available must be willing to undergo a biopsy of a tumour lesion prior to study entry, unless this is medically contraindicated (e.g. site inaccessible or patient safety concerns).

  13. Patients must have a mandatory treatment-free interval of at least 21 days following previous systemic anti-cancer treatments.

  14. Patients who have received previous systemic anticancer treatment and/or radiotherapy should have recovered from any treatment related toxicity, to a level of ≤ grade 1 (according to NCI-CTCAE criteria, v 4.0) with the exception of Grade 2 alopecia.

  15. Adequate hematologic function (absolute neutrophil count [ANC] ≥ 1.0 x109/L, platelets ≥ 100 x109/L, haemoglobin (Hb) ≥ 9 g/L) measured within 14 days of treatment initiation.

  16. Adequate renal function (creatinine clearance ≥ 50 mL/ using the MDRD or CKI EPI method) measured within 14 days of treatment initiation.

  17. Adequate hepatic function (serum bilirubin ≤ 1.5 x the reference upper limit of normal (ULN) unless due to Gilbert's syndrome; aspartate aminotransferase [ASAT] and alanine aminotransferase [ALAT] ≤ 2,5 xULN) measured within 14 days of treatment initiation. For patients with documented liver metastasis ASAT/ALAT ≤ 5x ULN is acceptable.

  18. Strictly normal blood levels of calcium and magnesium, measured within 14 days of treatment initiation.

  19. Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 1 (Oken, 1982).

  20. Estimated life expectancy ≥ 90 days.

  21. Patients who are sexually active must agree to use a medically accepted method of contraception (e.g. implants, injectables, combined oral contraceptives, some intrauterine devices or vasectomized partner, for participating women; condoms for participating men) or practice complete abstinence, beginning 14 days before the first administration of investigational product (IP), while on treatment and for at least 5 months after the last administration of IP for female patients, and 7 months after the last administration of IP for male patients.

  22. Women of childbearing potential must have a negative urine or serum pregnancy test within 72 hours prior to the first administration of IP. If urine test results are positive or cannot be confirmed as negative, a serum pregnancy test will be required.

  23. Women who are breastfeeding should discontinue nursing prior to the first administration of IP and for at least 90 days after the last administration of IP.

  24. Patients must be affiliated to a Social Security System or equivalent."

Critères de non-inclusion :
  1. "Prior treatment with an anti-PD1 or anti-PD-L1 antibody

  2. Eligible, and willing, to participate in a clinical trial of an alternative anticancer therapy targeting their disease which is open to accrual in France.

  3. Concurrent steroid medication at a dose greater than prednisone 10 mg/day or equivalent.

  4. Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.

  5. History of (non-infectious) pneumonitis that required steroids, or current pneumonitis.

  6. History of severe hypersensitivity reaction to any monoclonal antibody therapy

  7. Radiotherapy (except for brain and extremities) within 21 days prior to the first administration of IP.

  8. Treatment with other investigational drugs or participation in another clinical trial within 21 days prior to the first administration of IP or concomitantly with the trial.

  9. Has known symptomatic central nervous system (CNS) metastases. Patients with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least four weeks prior to the first dose of trial treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 7 days prior to trial treatment.

  10. Has known carcinomatous meningitis or a history of leptomeningeal disease.

  11. Serum creatinine > 1.5 xULN or glomerular filtration rate (GFR) < 50 ml/min.

  12. Lymphocytes count below 1,000/mm3 and CD4+ count below 500/mm3 as assessed by routine blood phenotyping. Critère supprimé avec amendement n°3

  13. Other malignancies within the past 5 years other than basal cell skin cancer or carcinoma in situ of the cervix.

  14. Active serious infections in particular if requiring systemic antibiotic or antimicrobial therapy. amendement n°4 : les patients atteints d'une hépatite A, B ou C guérie ainsi que les patients atteints d'une hépatite B ou C chronique pourront dorénavant être inclus dans le protocole sous certaines conditions décrites dans le protocole.

  15. Active or chronic hepatitis B, hepatitis C and/or human immunodeficiency virus (HIV) infection (HIV 1/2 antibodies), or a known history of active Tuberculosis bacillus.

  16. Has received a live vaccine within 30 days of planned start of study treatment. Note: Seasonal influenza vaccines for injection are generally inactivated vaccines and are allowed; however intranasal influenza vaccines (e.g. Flu-Mist®) are live attenuated vaccines, and are not allowed.

  17. Active alcohol or drug abuse.

  18. Psychological, familial, sociological or geographical factors potentially hampering compliance with the study protocol and follow-up schedule.

  19. Any condition which in the Investigator's opinion makes it undesirable for the subject to participate in the trial or which would jeopardize compliance with the protocol."

Centres investigateurs

Centres participants à l'essai Contact investigateur Contact TEC/IRC Patients inclus/à inclure Ouverts aux inclusions Maj
Rennes - CHU de Rennes - Site Hôpital Pontchaillou Pr Dupuy - Alain.DUPUY@chu-rennes.fr - 1 / 0 Oui 25/02/2019
NANTES - CHU Hépato-Digestif Dr Touchefeu Yann - DZIUKALA Catherine - / Non 12/06/2019
ANGERS - Institut de Cancérologie de l'Ouest ROLLAND Frederic - - / Oui 16/11/2018
Brest - CHU de Brest - Site Morvan - Abdelssam Chajara - abdesslam.chajara@chu-brest.fr 1 / nc Non 24/06/2019
NANTES - Institut de Cancérologie de l' Ouest ROLLAND Frederic - - / Oui 24/08/2018
Rennes - Centre Eugène Marquis Dr Fanny Le Du - Enora Lejeune - / Oui 24/08/2018
Afficher les détails
Acronyme : AAS-Lynch P130937
Spécialité : Digestif
Traitement : Autres traitements exclusifs
Ouvert aux inclusions : Oui

(Cliquer sur détails pour connaitre les centres)

Phase(s) : Phase III
Descriptif

Active Comparator: Aspirin300
Acetylsalicylic acid 300 mg tablet by mouth, daily dose during 4 years
Drug: Acetylsalicylic acid lysinate 300 mg
Daily dose during 4 years
Other Name: Aspirin300


Placebo Comparator: Placebo300
Placebo (like Acetylsalicylic acid 300 mg) tablet by mouth, daily dose during 4 years
Drug: Placebo (for Aspirin 300)
Daily dose during 4 years
Other Name: Placebo300


Active Comparator: Aspirin100
Acetylsalicylic acid 100 mg tablet by mouth, daily dose during 4 years
Drug: Acetylsalicylic acid lysinate 100 mg
Daily dose during 4 years
Other Name: Aspirin100


Placebo Comparator: Placebo100
Placebo (like Acetylsalicylic acid 100 mg) tablet by mouth, daily dose during 4 years
Drug: Placebo 100 (for Aspirin 100)
Daily dose during 4 years
Other Name: Placebo100

Informations

Chimioprévention par aspirine sur l’apparition ou la récidive

des adénomes colorectaux (Syndrome de Lynch)

Phase: 3

Promoteur: Assistance Publique - Hôpitaux de Paris
Acronymes: AAS-Lynch
P130937
Contact promoteur: Pr Robert BENAMOUZIG
Amal BOURKEB
Mail promoteur: robert.benamouzig@aphp.fr 
amal.bourkeb@aphp.fr
Source: clinicaltrials 26/01/2018

Cet essai dans d'autres annuaires :

Titre :

Assessment of the Effect of a Daily Chemoprevention by Low-dose Aspirin of New or Recurrent Colorectal Adenomas in Patients With Lynch Syndrome

Critères d'inclusion :
  1. Patient with Lynch syndrome bearing an alteration of "mismatch repair" genes or,when no characteristic alteration has been found, with a personal or family history of Lynch syndrome according to modified Amsterdam criteria

  2. Aged more than 25 years, et aged more than 18 years with an early familial history and any reason to perform a colonoscopy every 2 years

  3. Aged less than 75 years

Critères de non-inclusion :
  1. Known allergy to aspirin (including a history of asthma induced by the administration of salicylates or substances with similar activity, including non-steroidal anti-inflammatory)

  2. Need for a prolonged treatment (prevention of cardio-vascular risk) or repeated treatments (recurring migraines) using aspirin or another non-steroidal anti-inflammatory drug (NSAID)

  3. Pregnancy or breast feeding

  4. Participation to another clinical trial during the 12 weeks before inclusion

Centres investigateurs

Centres participants à l'essai Contact investigateur Contact TEC/IRC Patients inclus/à inclure Ouverts aux inclusions Maj
Rennes - Centre Eugène Marquis Dr Le Sourd Samuel - Gaëlle Kergoat - g.kergoat@rennes.unicancer.fr / Oui 29/01/2018
Afficher les détails
Acronyme : UNIRAD
Spécialité : Sénologie
Traitement : Autres traitements néoadjuvants
Ouvert aux inclusions : Oui

(Cliquer sur détails pour connaitre les centres)

Phase(s) : Phase III
Descriptif

Experimental: Everolimus
2 tablets/day (i.e.10mg/day )
Intervention: Drug: Everolimus
Placebo Comparator: Placebo
2 tablets/day
Intervention: Drug: Placebo

Informations

Phase: 3
Promoteur: UNIRAD
Autre(s) acronyme(s): NR
Contact promoteur: Jerome LEMONNIER, PhD
Mail promoteur: j-lemonnier@unicancer.fr
Tel promoteur: +33 1 7193 6702
Coordonnateur: Thomas Bachelot, MD, Centre Leon Berard/ Fabrice Andre, MD,Institut Gustave Roussy
Mail coordonnateur: NR
Tel Coordonnateur: NR
-
Source: Clinicaltrials.gov du 17/09/2013

Cet essai dans d'autres annuaires :

Titre :

Essai de phase III, randomisé en double aveugle, multicentrique, évaluant la tolérance et l’éfficacite de l’everolimus combiné à l’hormonothérapie adjuvante chez les femmes présentant un cancer du sein RE+/HER2- de mauvais pronostic et sans rechute après 3 ans d’hormonothérapie adjuvante

Critères d'inclusion :
  1. Women ≥ 18 years of age,

  2. Histologically proven invasive unilateral or bilateral breast cancer (regardless of the type),

  3. Any T, M0

  4. At least 4 positive lymph nodes if initial surgery, or at least 1 positive lymph node after neo-adjuvant chemotherapy or hormone therapy

  5. ER+ and HER2 negative : Hormone receptor positive is defined as any staining on the primary tumor, HER2 negativity is defined as IHC 0-1+, or [IHC 2+ and FISH or CISH negative]

  6. Initial tumor completely resected (surgery could have been done before or after neoadjuvant chemotherapy/hormone therapy)

  7. Having received at least 2 years and 10 months but not more than 3 years and 6 months of adjuvant hormone therapy. Hormone therapy could be either tamoxifen, letrozole, anastrozole or exemestane.

  8. No clinically or radiologically detectable metastases at time of inclusion.

  9. WHO Performance status (ECOG) of 0 or 1.

  10. Adequate hematological function (neutrophil count >= 2x109/l, platelet count >= 100x 109/l)

  11. Adequate hepatic function: ASAT and ALAT ≤ 2.5 ULN, alkaline phosphatases ≤ 2.5 ULN, total bilirubin ≤ 2 ULN.

  12. Adequate renal function: serum creatinine ≤ 1.5 ULN.

  13. Signed written informed consent.

Critères de non-inclusion :
  1. Any local, regional or metastatic evolution.

  2. Any clinically or radiologically suspect and non-explored damage to the contra lateral breast.

  3. Previous cancer (excepted cutaneous baso-cellular epithelioma or uterine peripheral epithelioma) in the preceding 5 years, including invasive controlateral breast cancer.

  4. Patients already included in another ongoing therapeutic trial involving an experimental drug for which follow-up is required.

  5. Pregnant or breast-feeding patients. Adequate birth control measures should be taken during study treatment phase.

  6. Patients with severely impaired lung function (e.g. Chronic Obstructive Pulmonary Disease, respiratory insufficiency, Interstitial Lung Disease)

  7. Positive serology for HIV infection or hepatitis C.

  8. Chronic carrier of HBV (positive Antigen HbS in the blood)

  9. Patients with chronic infection

  10. Uncontrolled diabetes defined as glycated haemoglobinemia > 7%

  11. Uncontrolled hypercholesterolemia (cholesterol >400 mg/dl under adequate therapy).

  12. Hypersensitivity to the active substance, to other rapamycin derivatives or to any of the excipients.

  13. Patients with other concurrent severe and/or uncontrolled medical disease or infection which could compromise participation in the study.

  14. Patients with any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial.

Centres investigateurs

Centres participants à l'essai Contact investigateur Contact TEC/IRC Patients inclus/à inclure Ouverts aux inclusions Maj
Lorient - Centre Hospitalier Bretagne Sud - Mariella Le Saux - m.lesaux@ch-bretagne-sud.fr

Tel: 02.97.06.96.94

nc / nc Oui 09/11/2018
Plérin - CARIO - HPCA Dr Anne-Claire HARDY-BESSARD - Aude Vincent - a.vincent@bec22.fr 22 / NC Oui 30/09/2019
Brest - CHU de Brest - Site Morvan Dr H. Simon - Abdelssam Chajara - abdesslam.chajara@chu-brest.fr 0 / Oui 26/09/2013
Quimper - CHI Cornouaille Dr Le Rol -

Tel: 02 98 52 66 30

Pascaline Rameau - p.rameau@ch-cornouaille.fr 14 / NC Oui 03/01/2019
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Acronyme : IMIREDUC
Spécialité : Dermatologie
Traitement : Autres traitements néoadjuvants
Ouvert aux inclusions : Oui

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Phase(s) : Phase III
Descriptif

•Experimental: Imiquimod
Intervention: Drug: Imiquimod cream + surgery
•Placebo Comparator: Placebo
Intervention: Drug: vehicle + surgery

Informations

Phase: 3
Promoteur: CHU DE NANTES
Autre(s) acronyme(s): BRD11/06-S
NCT01720407
Contact promoteur: Amir Khammari
Mail promoteur: amir.khammari@chu-nantes.fr
Tel promoteur: 02 53 48 32 80
Coordonnateur: Brigitte Dréno, MD, PhD
Mail coordonnateur: NR
Tel Coordonnateur: NR
-
Source: ClinicalTrials.gov du 04/07/2013

Titre :

Relevance of Imiquimod as Neo-adjuvant Treatment to Reduce Excision Size and the Risk of Intralesional Excision in Lentigo Malignant of the Face

Critères d'inclusion :
  1. Patients from both sexes aged over 18 years and operable

  2. Presenting with LM of the face or the neck, histologically confirmed by biopsy

  3. Patients presenting with a primitive lesion, of a surface ≥ to 1.5cm² and ≤ to 20cm², with the possibility of graft or flap reconstruction

  4. LM previously untreated by surgery

  5. LM without prior treatment with liquid nitrogen or any other local treatment within 3 months

  6. ECOG ≤ 2

  7. leucocytes ≥ 3,000/mm³

  8. Neutrophil count ≥ 1,500/mm³

  9. Platelet count ≥ 100,000/mm³

  10. Haemoglobin ≥ 9.0g/dL

  11. Absence of severe evolutive infection

  12. Absence of known HIV infection

  13. Absence of corticotherapy and treatment by immunosuppressive agents

  14. Membership to a social security insurance scheme.

  15. Negative pregnancy test conducted during the inclusion consultation for non-menopausal women.

  16. Signed informed consent

Critères de non-inclusion :
  1. LM located on the eyelids are excluded, together with LM in anatomic sites other than the face or the neck

  2. Melanomas other than LM

  3. LM with a surface area < to 1,5cm² or > to 20cm²

  4. LM of which the macroscopic contours cannot be defined

  5. Patients treated by immunosuppressive agents, immunomodulators, cytotoxic agents or corticosteroids (local and systemic) during the 4-week period prior to the selection visit

  6. Cutaneous reconstruction not possible

  7. Presence of associated evolutive neoplasia since less than 5 years (with the exception of basal cell carcinoma, Bowen's carcinoma and carcinoma in situ of the cervix)

  8. Patient refusing surgery under local or general anaesthesia

Centres investigateurs

Centres participants à l'essai Contact investigateur Contact TEC/IRC Patients inclus/à inclure Ouverts aux inclusions Maj
Rennes - CHU de Rennes - Site Hôpital Pontchaillou Pr Dupuy - Alain.DUPUY@chu-rennes.fr UIC - 61 / 11 Oui 25/02/2019
Brest - CHU de Brest - Site Morvan Pr. L. Misery - laurent.misery@chu-brest.fr Clémence kergoulay - clémence.kergoulay@chu-brest.fr 13 / nc Oui 18/06/2018
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Acronyme : REACTION EORTC-1417-LCG 2014-003090-42
Spécialité : Pneumologie
Traitement : Chimiothérapie
Ouvert aux inclusions : Oui

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Phase(s) : Phase II
Descriptif

Experimental: Pembrolizumab + chemotherapy
Pembrolizumab, in combination with cis/carboplatin and etoposide for 4 cycles intravenous 200mg on day 1 (every 3 weeks), pembrolizumab continued alone as continuation maintenance until progressive disease
Drug: Pembrolizumab
IV infusion at the dose of 200 mg on day 1 every 3 weeks
Other Names:
MK-3475
Keytruda
Drug: cis/carboplatin and etoposide
Cisplatin 80 mg/m2 or Carboplatin Area Under the Curve (AUC) 5 IV infusion on day 1 Etoposide 100 mg/m2 IV infusion on day 1, 2 and 3
Other Name: Platinol, Paraplatin and Etopophos


Active Comparator: Chemotherapy
4 cycles of cis/carboplatin and etoposide
Drug: cis/carboplatin and etoposide
Cisplatin 80 mg/m2 or Carboplatin Area Under the Curve (AUC) 5 IV infusion on day 1 Etoposide 100 mg/m2 IV infusion on day 1, 2 and 3
Other Name: Platinol, Paraplatin and Etopophos

Informations

Cancer du poumon à petites cellules disséminé

1ère ligne avancé ou métastatique

Phase: 2

Promoteur: EORTC
Acronymes: REACTION
EORTC-1417-LCG
2014-003090-42
Contact promoteur: Kin Jip Cheung
Mail promoteur: kin-jip.cheung@eortc.be
Tel promoteur: Kin Jip Cheung +32 2 774 16 07
Source: Clinicaltrials.gov du 08/03/2018"

Cet essai dans d'autres annuaires :

Titre :

A Phase II Study of Etoposide and Cis/Carboplatin With or Without Pembrolizumab in Untreated Extensive Small Cell Lung Cancer

Critères d'inclusion :
  1. Histologically or cytologically confirmed SCLC

  2. Extended disease according to the criteria of the Veteran's Administration - Lung Cancer Group (VALG): disease extended beyond a hemithorax and the supraclavicular node area. Pleural involvement will be considered as extended disease

  3. Assessment of adefquate tissue availability for PD-L1 immunohistochemistry testing

  4. Before patient registration, written informed consent must be given according to ICH-GCP, and national/local regulations

  5. Tumor assessment performed within 10 days before randomization. Patient may or may not have measurable disease

  6. Previous palliative brain radiotherapy is allowed if terminated at least 3 weeks before randomization

  7. Partial or complete response according to RECIST (Response Evaluation Criteria in Solid Tumors) 1.1 after 2 cycles of any platinum-based induction chemotherapy regimen

  8. Adequate hematopoietic, hepatic and renal function within 10 days before randomization defined as follows:

    Women of child bearing potential (WOCBP) must have a negative urine or serum pregnancy test within 72 hours before randomization

    1. Absolute neutrophil count (ANC) ≥ 1.5 x 10E9/L, Hemoglobin (Hb) ≥ 9 g/dL and platelet count ≥ 100 x 10E9/L
    2. Serum creatinine clearance ≥ 60 mL/min as calculated with Cockcroft-Gault formula
    3. Bilirubin ≤ 1.5 x ULN, ALT (SGTP) and AST (SGOT) ≤ 3 x ULN
    4. International Normalized Ratio (INR) or Prothrombin Time (PT) ≤ 1.5 x ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants
    5. Activated Partial Thromboplastin Time (aPTT) ≤ 1.5 x ULN unless subject is receiving anticoagulant therapy as long as a PTT is within therapeutic range of intended use of anticoagulants N.B. LDH level assessment is mandatory for randomization
  9. Patients of childbearing / reproductive potential should use adequate birth control measures, as defined by investigator, during the study treatment period and for at least 120 days after the last study treatment. A highly effective method of birth control is defined as those which result in low failure rate (i.e. less than 1% per year) when used consistently and correctly.

  10. Female subjects who are breast feeding should discontinue nursing before randomization and until 120 days after the last study treatment

Critères de non-inclusion :
  1. Prior systemic therapy for SCLC; previous treatment with platinum and etoposide concomitant with RT for limited disease is allowed if terminated at least 1 year before patient randomization

  2. known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Patients with previously treated brain metastases may participate provided they are stable (i.e. without evidence of progression by imaging and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and have not received steroids for at least 7 days before randomization

  3. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 3-4 (at registration) (patients who are judged by the investigator to be PS 2 due to primary disease are the only PS 2 patients who are eligible)

  4. ECOG PS 2-4 (at randomization)

  5. Less than 3 month life expectancy

  6. History of interstitial lung disease (ILD) or a history of (non-infectious) pneumonitis that required oral or IV steroids (other than COPD exacerbation) or current pneumonitis or current evidence of ILD

  7. Active autoimmune disease that has required systemic treatment in past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs), any replacement therapy (i.e. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment and is allowed

  8. Previous allogeneic tissue/solid organ transplant

  9. Active infection requiring therapy

  10. Known history of Human Immunodeficiency Virus (HIV) (known HIV 1/2 antibodies positive). No known active Hepatitis B or C. Active Hepatitis B is defined as a known positive HBsAg results. Active Hepatitis C is defined by a known positive Hep C Ab result and known quantitative HCV RNA results greater than the lower limits of detection of the assay

  11. Ongoing grade ≥ 2 peripheral neuropathy

  12. Prior treatment with platinum, anti-PD-1, anti-PD-L1/2, anti-CD127, CTLA-4 modulators

  13. Chronic use of immunosuppressive agents and/or systemic corticosteroids or any use in the 3 days before randomization:

  14. Corticosteroid use on study for management of ECIs (pembrolizumab Event of Clinical Interest), as pre-medication for the administration of chemotherapies, and/or a pre-medication for contrast allergies/reactions is allowed

  15. Daily prednisone at doses of 5-7.5 mg is allowed as an example of replacement therapy. Equivalent hydrocortisone doses are also permitted if administered as a replacement therapy

  16. Prior use of live vaccines within 30 days before randomization. Examples of live vaccines include, but are not limited to, the following : measles, mumps, rubella, chicken pox, shingles, yellow fever, H1N1 flu, rabies, BCG, and typhoid vaccine

  17. Presence of any clinical, psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial

  18. Concurrent treatment with any investigational agent within 4 weeks before randomization

Centres investigateurs

Centres participants à l'essai Contact investigateur Contact TEC/IRC Patients inclus/à inclure Ouverts aux inclusions Maj
Brest - CHU de Brest - Site Morvan - Abdelssam Chajara - abdesslam.chajara@chu-brest.fr / Oui 12/03/2018
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