Treatment After Irinotecan-based Frontline Therapy: Maintenance With Erbitux (in Patients wtRAS mCRC)
NCT ID: NCT02404935
Last Updated: 2022-03-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
139 participants
INTERVENTIONAL
2013-11-22
2021-10-25
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm A cetuximab
cetuximab 500 mg/m2 (every 2 weeks) until progression
Cetuximab
FOLFIRI and cetuximab
Arm B observation
observation until progression
FOLFIRI and cetuximab
Interventions
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Cetuximab
FOLFIRI and cetuximab
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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UNICANCER
OTHER
Responsible Party
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Principal Investigators
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Valérie Boige, Dr
Role: PRINCIPAL_INVESTIGATOR
Gustave Roussy, Cancer Campus, Grand Paris
Locations
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CHU- Hôpital Sud
Amiens, , France
Centre Hospitalier Universitaire d'Angers
Angers, , France
Centre Hospitalier d'Auxerre
Auxerre, , France
Institut Sainte Catherine
Avignon, , France
Centre Hospitalier Intercommunal Cote Basque
Bayonne, , France
Centre Hospitalier de Beauvais
Beauvais, , France
Centre Hospitalier de Béziers
Béziers, , France
Centre Hospitalier de Blois
Blois, , France
Hôpital Avicenne
Bobigny, , France
Clinqiue Tivoli
Bordeaux, , France
Institut Bergonie
Bordeaux, , France
Centre François Baclesse
Caen, , France
Hôpital Côte de nacre
Caen, , France
Centre Hospitalier Jean Rougier
Cahors, , France
Centre Hospitalier Jean Rougier
Cahors, , France
Centre Hospitalier Estaing
Clermont-Ferrand, , France
Hôpital du Bocage
Dijon, , France
Centre Hospitalier de la Dracénie
Draguignan, , France
Clinique du Mousseau
Évry, , France
Centre Hospitalier Intercommunal
Fréjus, , France
Centre hospitalier Départemental de Vendée - Les Oudairies
La Roche-sur-Yon, , France
Clinique du Cap d'Or
La Seyne-sur-Mer, , France
Hôpital Bicêtre
Le Kremlin-Bicêtre, , France
Centre Oscar Lambret
Lille, , France
Clinique Francois Chenieux
Limoges, , France
CHU de Limoges - Hôpital Dupuytren
Limoges, , France
Centre Léon Bérard
Lyon, , France
Hôpital Privé Clairval
Marseille, , France
Institut Paoli Calmettes
Marseille, , France
Centre Hospitalier Montelimar
Montélimar, , France
Centre de Cancérologie du Grand Montpellier - Clinique Clementville
Montpellier, , France
Institut régional du Cancer Montpellier
Montpellier, , France
Centre Antoine Lacassagne
Nice, , France
Centre Hospitalier d'Orléans La Source
Orléans, , France
Hôpital Saint Jean
Perpignan, , France
Polyclinique Francheville
Périgueux, , France
Centre Hospitalier Lyon Sud
Pierre-Bénite, , France
CHU - Robert Debre
Reims, , France
Centre Hospitalier de Romans
Romans, , France
Centre Hospitalier Hôpital Victor Provo
Roubaix, , France
Hôpital Saint Gregoire
Saint-Grégoire, , France
Clinique Mutualiste de l'Estuaire
Saint-Nazaire, , France
CHU Saint Etienne - Hôpital Nord
Saint-Priest-en-Jarez, , France
Centre Paul Strauss
Strasbourg, , France
Polyclinique de l'Ormeau
Tarbes, , France
Centre Hospitalier Intercommunal de Toulon
Toulon, , France
Gustave Roussy
Villejuif, Île-de-France Region, France
Countries
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References
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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.
Other Identifiers
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2012-005139-99
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
Prodige 28 - UCGI 27 (TIME)
Identifier Type: -
Identifier Source: org_study_id
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