Spots Global Cancer Trial Database for Efficacy of Chemotherapy, Associated to Either Cetuximab or Bevacizumab, in KRAS Wild-type Metastatic Colorectal Cancer Patients With Progressive Disease After Receiving First-line Treatment With Bevacizumab
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Trial Identification
Brief Title: Efficacy of Chemotherapy, Associated to Either Cetuximab or Bevacizumab, in KRAS Wild-type Metastatic Colorectal Cancer Patients With Progressive Disease After Receiving First-line Treatment With Bevacizumab
Official Title: Phase II, Multicentric Randomized Trial, Evaluating the Efficacy of Fluoropyrimidine-based Standard Chemotherapy, Associated to Either Cetuximab or Bevacizumab, in KRAS Wild-type Metastatic Colorectal Cancer Patients With Progressive Disease After Receiving First-line Treatment With Bevacizumab
Study ID: NCT01442649
Conditions
Study Description
Brief Summary: The main objective is to evaluate progression-free survival (PFS) at 4 months. The secondary objectives are to evaluate the objective response rate (OR) (= complete responses (CR) and partial responses (PR)) according to the RECIST v1.1 criteria, the progression-free survival (PFS), the overall survival (OS), the overall survival from the date of the first-line chemotherapy used on the metastatic disease, the treatment tolerance (NCI CTC AE V4 criteria, except for peripheral neurological toxicity (Lévi Scale)), the quality of life according to the EORTC QLQ-C30 criteria. The objectives of the biological study are to evaluate potentially predictive anti-EGFR and anti-VEGF response factors and CEC rates as predictive biomarkers for the efficacy of bevacizumab associated with chemotherapy in mCRC treatment.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Centre rené Gauducheau, Saint-herblain, , France
Contact Details
Name: Jaafar BENNOUNA, Dr
Affiliation: Centre René Gauducheau
Role: PRINCIPAL_INVESTIGATOR
Name: Christophe BORG, Pr
Affiliation: CHU Jean Minjoz-BESANCON
Role: PRINCIPAL_INVESTIGATOR
Name: Christian BOREL, Dr
Affiliation: Centre Paul Strauss-STRASBOURG
Role: PRINCIPAL_INVESTIGATOR
Name: Jean-Pierre DELORD, Pr
Affiliation: Institut Claudius Regaud-TOULOUSE
Role: PRINCIPAL_INVESTIGATOR
Name: Christophe BORG, Pr.
Affiliation: Centre Hospitalier du Mittan-MONTBELIARD
Role: PRINCIPAL_INVESTIGATOR
Name: Jean-François SEITZ, Pr
Affiliation: CHU Timone-MARSEILLE
Role: PRINCIPAL_INVESTIGATOR
Name: Thierry CONROY, Pr
Affiliation: Centre Alexis Vautrin-VANDOEUVRE LES NANCY
Role: PRINCIPAL_INVESTIGATOR
Name: Roger FAROUX, Dr
Affiliation: CHD Vendée-LA ROCHE SUR YON
Role: PRINCIPAL_INVESTIGATOR
Name: Eric FRANCOIS, Dr
Affiliation: Centre Antoine Lacassagne-NICE
Role: PRINCIPAL_INVESTIGATOR
Name: Alice GAGNAIRE, Dr
Affiliation: Hôpital Bocage-DIJON
Role: PRINCIPAL_INVESTIGATOR
Name: Antoine ADENIS, Pr
Affiliation: Centre Oscar Lambret-LILLE
Role: PRINCIPAL_INVESTIGATOR
Name: Cédric LECAILLE, Dr
Affiliation: Polyclinique Bordeaux Nord Aquitaine-BORDEAUX
Role: PRINCIPAL_INVESTIGATOR
Name: Gaël DEPLANQUE, Dr
Affiliation: Groupe hospitalier St Joseph-PARIS
Role: PRINCIPAL_INVESTIGATOR
Name: Pascal ARTRU, Dr
Affiliation: Hôpital Privé Jean Mermoz-LYON
Role: PRINCIPAL_INVESTIGATOR
Name: Oana COJOCARASU, Dr
Affiliation: Centre hospitalier du Mans-LE MANS
Role: PRINCIPAL_INVESTIGATOR
Name: Laurent MIGLIANICO, Dr
Affiliation: CHP Saint Grégoire-SAINT GREGOIRE
Role: PRINCIPAL_INVESTIGATOR
Name: Olivier BOUCHE, Pr
Affiliation: Hôpital Robert Debré - CHU Reims
Role: PRINCIPAL_INVESTIGATOR
Name: You-Heng LAM, Dr
Affiliation: Centre Hospitalier de Cholet
Role: PRINCIPAL_INVESTIGATOR
Name: David TOUGERON, Dr
Affiliation: CHU de Poitiers-POITIERS
Role: PRINCIPAL_INVESTIGATOR
Name: Barbara DAUVOIS, Dr
Affiliation: CHR d'Orléans - Hôpital la Source
Role: PRINCIPAL_INVESTIGATOR
Name: Philippe HOUYAU, Dr
Affiliation: Clinique Claude Bernard, Albi
Role: PRINCIPAL_INVESTIGATOR
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