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Brief Title: De-escalation Chemotherapies Versus Escalation in Non Pre-treated Unresectable Patients With Metastatic Colorectal Cancer
Official Title: Randomized Phase II Study Assessing the Efficacy and Safety of 2 Therapeutic Strategies Combining Bevacizumab With Chemotherapy: De-escalation Versus Escalation in Patients With Non-pretreated Unresectable Metastatic Colorectal Cancer
Study ID: NCT02842580
Brief Summary: The intensity of tumour response appears to be correlated with the feasibility and the duration of a therapeutic pause or of a reduced maintenance therapy maintained until progression in patients initially controlled by so-called "induction" chemotherapy. Bevacizumab combined with cytotoxic chemotherapy (5-FU, irinotecan and/or oxaliplatin) has shown that it is possible to improve the tumour response rate and patient prognosis in 1st and 2nd lines. With a very favourable safety profile , it is an excellent candidate as induction treatment and also as maintenance treatment. Prospective data from recent trials have actually demonstrated improvement in PFS and/or overall survival with bevacizumab maintenance alone or in combination with 5FU (or capecitabine) after induction chemotherapy (FOLFIRI or FOLFOX + bevacizumab). At the same time, the maintenance of anti-angiogenic pressure after progression in 1st line metastatic has demonstrated its benefit in terms of PFS and overall survival. Bevacizumab maintenance in 2nd line metastatic, despite progression, thus appears to be a valid strategy.
Detailed Description: Thus, the objective of this work is to combine continuous blocking of angiogenesis by bevacizumab given on the first 3 metastatic lines in a randomised phase II trial evaluating a "descending" strategy of immediate optimisation by 4 cycles of FOLFOXIRI-bevacizumab and 4 cycles of FOLFIRI-bevacizumab, followed by maintenance treatment with 5FU-bevacizumab until progression (re-introduction of induction in case of progression) and evaluate an "ascending" strategy with 5FU-bevacizumab immediately followed, at progression, by the introduction of irinotecan, then oxaliplatin, with maintenance of blocking of angiogenesis by bevacizumab.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Hopital Pierre Oudot - Service de Gastroenterologie, Bourgoin-Jallieu, , France
Ch de Cholet - Service Maladies de L4Appareil Digestif Du Dr Kaasis, Cholet, , France
Chd Vendee - Service D'Hge, La Roche-sur-Yon, , France
Ch Annecy Genevois - Service Hge, Pringy, , France
CH - Annecy Genevois, Pringy, , France
Chu Robert Debre - Medecine Ambulatoire-Cancerologie, Reims CEDEX, , France
CHU Robert DEBRE, Reims, , France
Chu Charles Nicolle - Service D'Hge, Rouen CEDEX 01, , France
Hopital Prive Saint Gregoire - Service de Radiotherapie, Saint-Grégoire, , France
Centre Hospitalier de St Malo - Service Hepato-Gastro-Enterologie, Saint-Malo, , France
Chu de Saint Etienne-Hopital Nord - Service Hge, Saint-Priest-en-Jarez, , France
Name: Jean Marc PHELIP, MD-PhD
Affiliation: CHU St Etienne
Role: PRINCIPAL_INVESTIGATOR