SHIVA is a proof of concept randomized phase II trial which compares two treatment strategies for patients with refractory cancer. From a tumor biopsy, a molecular profile of the disease is established (mutations, amplifications, hormone receptor status). If a molecular abnormality is identified for which an approved targeted agent is available, patients are randomized randomized between two arms: * Targeted therapy based on the molecular profile * Conventional therapy based on investigator's choice. A cross-over is proposed at disease progression.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
742
Centre régional de lutte contre le cancer de Bourgogne Georges François Leclerc
Dijon, France
Centre Leon Berard
Lyon, France
Institut Paoli Calmettes
Marseille, France
Insitut Curie
Paris, France
Institut Curie Hopital Rene Huguenin
Saint-Cloud, France
Institut de cancérologie de l'Ouest Centre René Gauducheau
Saint-Herblain, France
Institut Claudius Régaud
Toulouse, France
Centre Alexis Vautrin
Vandœuvre-lès-Nancy, France
Patient's progression free survival (according RECIST 1.1) of targeted therapy based on molecular profiling versus conventional chemotherapy.
Tumor evaluation according to RECIST 1.1 criteria (every 2 months)
Overall response rate (ORR)
Tumor evaluation according to RECIST 1.1 criteria (every 2 months)
Overall Survival (OS)
Treatments side effects assessement according to the NCI CTCAE v4.03 scale.
Treatment effect variations as defined by tumor growth according to the altered signaling pathway
Evaluation of tumor growth before and during the study (according to RECIST 1.1)
Patient's progression free survival (according RECIST 1.1) of targeted therapy based on molecular profiling versus conventional chemotherapy after cross-over.
Tumor evaluation according to RECIST 1.1 criteria (every 2 months)
Evaluation of the ability of ctDNA to early predict treament efficacy
Comparing treatment efficacy to ctDNA level (before and during treatment course)
Evaluation of the medico-economic impact of the experimental strategy
Technical feasability of the SHIVA trial: number of screened patient compared to number of patients elligible to randomization.
Number of screened patients. Number of patient with a molecular full profil in the timeframe (4 weeks between tumor biopsy and SHIVA's committees decision). Number of randomized patient.
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