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Treatment After Irinotecan-based Frontline Therapy: Maintenance With Erbitux (in Patients wtRAS mCRC) (TIME)

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ClinicalTrials.gov Identifier: NCT02404935
Recruitment Status : Recruiting
First Posted : April 1, 2015
Last Update Posted : May 9, 2019
Sponsor:
Information provided by (Responsible Party):
UNICANCER

Brief Summary:
National multicentric phase II trial evaluating whether single agent cetuximab is effective as maintenance therapy after 8 cycles of first line FOLFIRI plus cetuximab in mCRC patients with KRAS and NRAS wild-type genes, assessed by progression-free survival at 6 months after start of maintenance therapy.

Condition or disease Intervention/treatment Phase
Metastatic Colorectal Cancer Drug: Cetuximab Drug: FOLFIRI and cetuximab Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 134 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Phase II Study of First-line FOLFIRI Plus Cetuximab for 8 Cycles Followed by Either Single-agent Cetuximab as Maintenance Therapy or Observation in Patients With Wild-type KRAS and NRAS Metastatic Colorectal Cancer
Actual Study Start Date : November 22, 2013
Estimated Primary Completion Date : October 1, 2019
Estimated Study Completion Date : March 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Cetuximab

Arm Intervention/treatment
Experimental: Arm A cetuximab
cetuximab 500 mg/m2 (every 2 weeks) until progression
Drug: Cetuximab
Drug: FOLFIRI and cetuximab
Arm B observation
observation until progression
Drug: FOLFIRI and cetuximab



Primary Outcome Measures :
  1. Progression Free Survival at 6 months [ Time Frame: 6 months after start of maintenance therapy ]
    Endpoints will include Progression assessed by CT Scan according to RECIST 1.1 criteria and Death from any cause



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Histologically confirmed colorectal cancer
  2. KRAS and NRAS wild-type genes after analysis of mutation status from the primary tumour or metastasis
  3. Non resectable metastatic disease in a curative intent
  4. No prior chemotherapy except for fluoropyrimidines with or without oxaliplatin-based adjuvant treatment, at least 6 months before inclusion
  5. At least one measurable tumour target (higher than 20 mm) according to RECIST criteria, which has never been irradiated
  6. Life expectancy above 3 months
  7. Performance Status ≤2 (WHO)
  8. Patient ≥18 years-old
  9. Acceptable blood test
  10. Patient having signed a written informed consent form

Exclusion Criteria:

  1. Known and/or symptomatic brain metastases
  2. Known allergy to one of treatment components
  3. Neurological or psychiatric condition which could interfere with good treatment compliance
  4. Current anti-tumour treatment : chemotherapy or targeted therapy or radiotherapy ≤ 14 days before randomisation
  5. Other severe conditions such as: respiratory failure. History of interstitial lung disease e.g. pneumonitis or pulmonary fibrosis or evidence of interstitial lung disease on baseline chest CT scan
  6. Clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) 6 months before enrollment/randomization
  7. Concomitant severe infection
  8. History of cancer (except skin cancer other than melanoma or an in situ cervical epithelioma or other solid tumour treated for curative purposes without signs of the condition and with no treatment administered in the 5 years before randomisation.)
  9. Patient already included in another clinical trial with an investigational molecule
  10. Prior treatment with anti-EGFr antibodies (e.g. panitumumab (Vectibix® or cetuximab / Erbitux® ) or treatment with small EGFr inhibitor molecules (e.g., erlotinib / Tarceva®)
  11. Pregnant female, likely to be or currently breastfeeding, or planning to become pregnant within 6 months after the end of treatment or absence of effective contraception for males and females of childbearing age during treatment and for 6 months (male or female) after the end of treatment
  12. Those deprived of their freedom or under guardianship
  13. Impossibility of undergoing trial's medical follow-up for geographical, social or psychological reasons

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02404935


Contacts
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Contact: Nicolas LACHAUX +33 1 71 93 61 60 n-lachaux@unicancer.fr
Contact: Emilie BRUMENT +33 1 71 93 61 64 e-brument@unicancer.fr

Locations
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France
Gustave Roussy Recruiting
Villejuif, Ile De France, France, 94805
Contact: Valérie Boige    +33 1 42 11 42 89    valerie.boige@gustaveroussy.fr   
Principal Investigator: Valérie BOIGE, Dr         
CHU- Hôpital Sud Recruiting
Amiens, France, 80054
Contact: Vincent Hautefeuille    + 33 2 22 66 82 00    hautefeuille.vincent@chu-amiens.fr   
Principal Investigator: Vincent HAUTEFEUILLE, Dr         
Centre Hospitalier Universitaire d'Angers Recruiting
Angers, France, 49933
Contact: François-Xavier Caroli-Bosc    +33 2 41 35 34 07    fxcaroli-bosc@chu-angers.fr   
Principal Investigator: François-Xavier CAROLI-BOSC, Dr         
Centre Hospitalier d'Auxerre Recruiting
Auxerre, France, 89011
Contact: Anne-Laure Villing    +33 3 86 48 47 13    alvilling@ch-auxerre.fr   
Principal Investigator: Anne-Laure VILLING, Dr         
Institut Sainte Catherine Recruiting
Avignon, France, 84918
Contact: Laurent Mineur    +33 4 90 27 62 68    l.mineur@isc84.org   
Principal Investigator: Laurent MINEUR, Dr         
Centre Hospitalier Intercommunal Cote Basque Recruiting
Bayonne, France, 64109
Contact: Franck Audemar    + 33 5 59 44 37 22    faudemar@ch-cotebasque.fr   
Principal Investigator: Franck AUDEMAR, Dr         
Centre Hospitalier de Beauvais Recruiting
Beauvais, France, 60021
Contact: Faycal Hocine    +33 3 44 11 21 22    fayoncologie@yahoo.fr   
Principal Investigator: Faycal HOCINE, Dr         
Centre Hospitalier de Blois Recruiting
Blois, France, 41000
Contact: Dany Gargot    +33 2 54 55 63 75    dgargot@ch-blois.fr   
Principal Investigator: Dany GARGOT, Dr         
Hôpital Avicenne Recruiting
Bobigny, France, 93009
Contact: Thomas Aparicio    +33 1 40 25 72 00    thomas.aparicio@avc.aphp.fr   
Clinqiue Tivoli Recruiting
Bordeaux, France, 33000
Contact: Nathalie Bonichon Lamichhane    + 33 5 56 11 60 87    bonichon-lamichhane@wanadoo.fr   
Principal Investigator: Nathalie BONICHON LAMICHHANE, Dr         
Institut Bergonie Recruiting
Bordeaux, France, 33076
Contact: Dominique Bechade    +33 5 56 33 32 65    d.bechade@bordeaux.unicancer.fr   
Principal Investigator: Dominique BECHADE, Dr         
Centre Hospitalier de Béziers Recruiting
Béziers, France, 34500
Contact: Mohamed Ramdani         
Principal Investigator: Mohamed RAMDANI, Dr         
Centre François Baclesse Recruiting
Caen, France, 14033
Contact: Marie-Pierre Galais    +33 2 31 45 52 71    mp.gallais@baclesse.unicancer.fr   
Principal Investigator: Marie-Pierre GALAIS, Dr         
Hôpital Côte de nacre Active, not recruiting
Caen, France, 14033
Centre Hospitalier Jean Rougier Recruiting
Cahors, France, 46000
Contact: Nadia Djabali Levasseur    +33 5 65 20 50 21    nadia.levasseur@ch-cahors.fr   
Principal Investigator: Nadia DJABALI LEVASSEUR, Dr         
Centre Hospitalier Jean Rougier Recruiting
Cahors, France
Contact: Nadia DJABALI LEVASSEUR, Dr         
Principal Investigator: Nadia DJABALI LEVASSEUR, Dr         
Centre Hospitalier Estaing Recruiting
Clermont-Ferrand, France, 63003
Contact: Caroline Petorin    +33 4 73 75 05 08    cpetorin@chu-clermontferrand.fr   
Principal Investigator: Caroline PETORIN, Dr         
Hôpital du Bocage Recruiting
Dijon, France, 21079
Contact: Jean-Louis Jouve    + 33 3 80 29 37 50    jean-louis.jouve@chu-dijon.fr   
Principal Investigator: Jean-Louis JOUVE, Dr         
Centre Hospitalier de la Dracénie Active, not recruiting
Draguignan, France, 83007
Clinique du Mousseau Active, not recruiting
Evry, France, 91035
Centre Hospitalier Intercommunal Recruiting
Frejus, France, 83007
Contact: Bruno Valenza    +33 4 94 40 25 80    valenza-b@chi-frejus-saint-raphael.fr   
Principal Investigator: Bruno VALENZA, Dr         
Centre hospitalier Départemental de Vendée - Les Oudairies Recruiting
La Roche-sur-Yon, France, 85925
Contact: Roger Faroux    +33 2 51 44 61 68    roger.faroux@chd-vendee.fr   
Principal Investigator: Roger FAROUX, Dr         
Clinique du Cap d'Or Active, not recruiting
La Seyne-sur-Mer, France, 83500
Hôpital Bicêtre Active, not recruiting
Le Kremlin Bicêtre, France, 94275
Centre Oscar Lambret Recruiting
Lille, France, 59020
Contact: Farid El Hajbi    +33 3 20 29 59 42    f-elhajbi@o-lambret.fr   
Principal Investigator: Farid EL HAJBI, Dr         
Clinique Francois Chenieux Recruiting
Limoges, France, 87039
Contact: Dominique Genet    +33 5 55 45 48 00    dg@imagemed-87.com   
Principal Investigator: Dominique GENET, Dr         
CHU de Limoges - Hôpital Dupuytren Recruiting
Limoges, France, 87042
Contact: Valérie Le Brun-Ly    + 33 5 55 05 63 96    valerie.lebrun@chu-limoges.fr   
Principal Investigator: Valérie LE BRUN-LY, Dr         
Centre Léon Bérard Recruiting
Lyon, France, 69373
Contact: Christelle De La Fouchardière    +33 4 78 78 27 51    christelle.delafouchardire@lyon.unicancer.fr   
Principal Investigator: Christelle DE LA FOUCHARDIERE, Dr         
Hôpital Privé Clairval Active, not recruiting
Marseille, France, 13009
Institut Paoli Calmettes Recruiting
Marseille, France, 13273
Contact: Jean Luc Raoul    +33 4 91 22 37 78    raouljl@ipc.unicancer.fr   
Principal Investigator: Jean Luc RAOUL, Dr         
Centre Hospitalier Montelimar Active, not recruiting
Montelimar, France, 26216
Centre de Cancérologie du Grand Montpellier - Clinique Clementville Recruiting
Montpellier, France, 34070
Contact: Stéphane Jacquot    +33 4 67 92 61 55    jacquot@oncoclem.org   
Principal Investigator: Stéphane JACQUOT, Dr         
Institut régional du Cancer Montpellier Recruiting
Montpellier, France, 34298
Contact: Emmanuelle SAMALIN       Emmanuelle.Samalin@icm.unicancer.fr   
Principal Investigator: Emmanuelle SAMALIN, Dr         
Centre Antoine Lacassagne Recruiting
Nice, France, 06189
Contact: Eric Francois    +33 4 92 03 11 14      
Principal Investigator: Eric FRANCOIS, Dr         
Centre Hospitalier d'Orléans La Source Active, not recruiting
Orléans, France, 45067
Polyclinique Francheville Recruiting
Perigueux, France, 24004
Contact: Charles-Briac Levaché    +33 5 53 02 12 32    ch.levache@oncoradio24.com   
Principal Investigator: Charles-Briac LEVACHE, Dr         
Hôpital Saint Jean Recruiting
Perpignan, France, 66046
Contact: Faiza Khemissa Akouz    +33 4 68 61 66 33    faiza.khemisse@ch-perpignan.fr   
Principal Investigator: Faiza KHEMISSA AKOUZ, Dr         
Centre Hospitalier Lyon Sud Active, not recruiting
Pierre Bénite, France, 69495
CHU - Robert Debre Recruiting
Reims, France, 51092
Contact: Olivier Bouche, MD, PhD    +33 3 26 78 71 69    obouche@chu-reims.fr   
Principal Investigator: Olivier BOUCHE, Pr         
Centre Hospitalier de Romans Active, not recruiting
Romans, France, 26100
Centre Hospitalier Hôpital Victor Provo Recruiting
Roubaix, France, 59056
Contact: Sylvie Block    +33 3 20 99 34 38    sylvie.block@ch-roubaix.fr   
Principal Investigator: Sylvie BLOCK, Dr         
Hôpital Saint Gregoire Recruiting
Saint Gregoire, France, 35768
Contact: Laurent Miglianico    +33 2 99 54 09 49    lmiglianico@vivalto-sante.com   
Principal Investigator: Laurent MIGLIANICO, Dr         
Clinique Mutualiste de l'Estuaire Recruiting
Saint Nazaire, France, 44606
Contact: Catherine Ligeza Poisson    +33 2 72 27 54 02    catherine.ligeza@mla.fr   
Principal Investigator: Catherine LIGEZA POISSON, Dr         
CHU Saint Etienne - Hôpital Nord Recruiting
Saint-Priest-en-Jarez, France, 42270
Contact: Jean-Marc Phelip    +33 4 77 82 83 20    J.marc.phelip@chu-st-etienne.fr   
Principal Investigator: Jean-Marc PHELIP, Pr         
Centre Paul Strauss Recruiting
Strasbourg, France, 67065
Contact: Meher Ben Abdelghani    +33 3 88 25 85 25    mbenabdelghani@strasbourg.unicancer.fr   
Principal Investigator: Meher BEN ABDELGHANI, Dr         
Polyclinique de l'Ormeau Recruiting
Tarbes, France
Contact: Philippe Ayela, Dr         
Principal Investigator: Philippe AYELA, Dr         
Centre Hospitalier Intercommunal de Toulon Active, not recruiting
Toulon, France, 83056
Sponsors and Collaborators
UNICANCER
Investigators
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Principal Investigator: Valérie Boige, Dr Gustave Roussy, Cancer Campus, Grand Paris

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Responsible Party: UNICANCER
ClinicalTrials.gov Identifier: NCT02404935     History of Changes
Other Study ID Numbers: Prodige 28 - UCGI 27 (TIME)
2012-005139-99 ( EudraCT Number )
First Posted: April 1, 2015    Key Record Dates
Last Update Posted: May 9, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by UNICANCER:
Metastatic colorectal cancer
cetuximab
maintenance
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Cetuximab
Antineoplastic Agents, Immunological
Antineoplastic Agents