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Spots Global Cancer Trial Database for De-escalation Chemotherapies Versus Escalation in Non Pre-treated Unresectable Patients With Metastatic Colorectal Cancer

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Trial Identification

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

Study Description

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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Name: Jean Marc PHELIP, MD-PhD

Affiliation: CHU St Etienne

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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