Treatment After Irinotecan-based Frontline Therapy: Maintenance With Erbitux (in Patients wtRAS mCRC)
TIME
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
2 other identifiers
interventional
139
1 country
47
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Nov 2013
Longer than P75 for phase_2
47 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 22, 2013
CompletedFirst Submitted
Initial submission to the registry
March 23, 2015
CompletedFirst Posted
Study publicly available on registry
April 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
October 25, 2021
CompletedMarch 24, 2022
March 1, 2022
6.9 years
March 23, 2015
March 23, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression Free Survival at 6 months
Endpoints will include Progression assessed by CT Scan according to RECIST 1.1 criteria and Death from any cause
6 months after start of maintenance therapy
Study Arms (2)
Arm A cetuximab
EXPERIMENTALcetuximab 500 mg/m2 (every 2 weeks) until progression
Arm B observation
OTHERobservation until progression
Interventions
Eligibility Criteria
You may qualify if:
- Histologically confirmed colorectal cancer
- KRAS and NRAS wild-type genes after analysis of mutation status from the primary tumour or metastasis
- Non resectable metastatic disease in a curative intent
- At least one measurable tumour target (higher than 20 mm) according to RECIST criteria, which has never been irradiated
- Life expectancy above 3 months
- Performance Status ≤2 (WHO)
- Patient ≥18 years-old
- Acceptable blood test
- Patient having signed a written informed consent form
You may not qualify if:
- Known and/or symptomatic brain metastases
- Known allergy to one of treatment components
- Neurological or psychiatric condition which could interfere with good treatment compliance
- Current anti-tumour treatment : chemotherapy or targeted therapy or radiotherapy ≤ 14 days before randomisation
- 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
- Clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) 6 months before enrollment/randomization
- Concomitant severe infection
- 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.)
- Patient already included in another clinical trial with an investigational molecule
- Prior treatment with anti-EGFr antibodies (e.g. panitumumab (Vectibix® or cetuximab / Erbitux® ) or treatment with small EGFr inhibitor molecules (e.g., erlotinib / Tarceva®)
- 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
- Those deprived of their freedom or under guardianship
- Impossibility of undergoing trial's medical follow-up for geographical, social or psychological reasons
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- UNICANCERlead
Study Sites (47)
CHU- Hôpital Sud
Amiens, 80054, France
Centre Hospitalier Universitaire d'Angers
Angers, 49933, France
Centre Hospitalier d'Auxerre
Auxerre, 89011, France
Institut Sainte Catherine
Avignon, 84918, France
Centre Hospitalier Intercommunal Cote Basque
Bayonne, 64109, France
Centre Hospitalier de Beauvais
Beauvais, 60021, France
Centre Hospitalier de Béziers
Béziers, 34500, France
Centre Hospitalier de Blois
Blois, 41000, France
Hôpital Avicenne
Bobigny, 93009, France
Clinqiue Tivoli
Bordeaux, 33000, France
Institut Bergonie
Bordeaux, 33076, France
Centre François Baclesse
Caen, 14033, France
Hôpital Côte de nacre
Caen, 14033, France
Centre Hospitalier Jean Rougier
Cahors, 46000, France
Centre Hospitalier Jean Rougier
Cahors, France
Centre Hospitalier Estaing
Clermont-Ferrand, 63003, France
Hôpital du Bocage
Dijon, 21079, France
Centre Hospitalier de la Dracénie
Draguignan, 83007, France
Clinique du Mousseau
Évry, 91035, France
Centre Hospitalier Intercommunal
Fréjus, 83007, France
Centre hospitalier Départemental de Vendée - Les Oudairies
La Roche-sur-Yon, 85925, France
Clinique du Cap d'Or
La Seyne-sur-Mer, 83500, France
Hôpital Bicêtre
Le Kremlin-Bicêtre, 94275, France
Centre Oscar Lambret
Lille, 59020, France
Clinique Francois Chenieux
Limoges, 87039, France
CHU de Limoges - Hôpital Dupuytren
Limoges, 87042, France
Centre Léon Bérard
Lyon, 69373, France
Hôpital Privé Clairval
Marseille, 13009, France
Institut Paoli Calmettes
Marseille, 13273, France
Centre Hospitalier Montelimar
Montélimar, 26216, France
Centre de Cancérologie du Grand Montpellier - Clinique Clementville
Montpellier, 34070, France
Institut régional du Cancer Montpellier
Montpellier, 34298, France
Centre Antoine Lacassagne
Nice, 06189, France
Centre Hospitalier d'Orléans La Source
Orléans, 45067, France
Hôpital Saint Jean
Perpignan, 66046, France
Polyclinique Francheville
Périgueux, 24004, France
Centre Hospitalier Lyon Sud
Pierre-Bénite, 69495, France
CHU - Robert Debre
Reims, 51092, France
Centre Hospitalier de Romans
Romans, 26100, France
Centre Hospitalier Hôpital Victor Provo
Roubaix, 59056, France
Hôpital Saint Gregoire
Saint-Grégoire, 35768, France
Clinique Mutualiste de l'Estuaire
Saint-Nazaire, 44606, France
CHU Saint Etienne - Hôpital Nord
Saint-Priest-en-Jarez, 42270, France
Centre Paul Strauss
Strasbourg, 67065, France
Polyclinique de l'Ormeau
Tarbes, France
Centre Hospitalier Intercommunal de Toulon
Toulon, 83056, France
Gustave Roussy
Villejuif, Île-de-France Region, 94805, France
Related Publications (1)
Boige V, Blons H, Francois E, Ben Abdelghani M, Phelip JM, Le Brun-Ly V, Mineur L, Galais MP, Villing AL, Hautefeuille V, Miglianico L, De La Fouchardiere C, Genet D, Levasseur N, Levache CB, Penel N, Mitry E, Jacquot S, Aparicio T, Brument E, Gourgou S, Castan F, Bouche O. Maintenance Therapy With Cetuximab After FOLFIRI Plus Cetuximab for RAS Wild-Type Metastatic Colorectal Cancer: A Phase 2 Randomized Clinical Trial. JAMA Netw Open. 2023 Sep 5;6(9):e2333533. doi: 10.1001/jamanetworkopen.2023.33533.
PMID: 37721754DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Valérie Boige, Dr
Gustave Roussy, Cancer Campus, Grand Paris
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 23, 2015
First Posted
April 1, 2015
Study Start
November 22, 2013
Primary Completion
November 1, 2020
Study Completion
October 25, 2021
Last Updated
March 24, 2022
Record last verified: 2022-03