Recruitment

Recruitment Status
Active, not recruiting
Estimated Enrollment
250

Summary

Conditions
Advanced Solid Tumor
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Arm A: Tumor-based genomics according to the 324 cancer-related genes Next Generation Sequencing (NGS) panel from Foundation One (FOne panel). Arm B: Tumor-based genomics according to the 87 cancer-related genes NGS panel performed at Centre Leon Berard "Unité de Caractérisation Tumorale" (CONTROL panel). Both panels will be performed concomitantly for all patients using the same patient tumor specimen.Masking: None (Open Label)Primary Purpose: Diagnostic

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Description

The genetic and immunologic profile of the tumor will be determined from archival or fresh collected tumor sample. For each patient, the tumor genomics data will be reviewed, at time of documented progressive disease, independently by a dedicated MTB to make a recommendation of therapy for a given p...

The genetic and immunologic profile of the tumor will be determined from archival or fresh collected tumor sample. For each patient, the tumor genomics data will be reviewed, at time of documented progressive disease, independently by a dedicated MTB to make a recommendation of therapy for a given patient based on its molecular profile. First, the genomics data issued from the panel defined by the randomization will be reviewed and recommended therapy resulting from randomization will be revealed to the Investigator. If a recommended therapy can be identified, this therapy will be recommended. If none recommended therapy can be identified, the 2nd panel performed will then be reviewed. In case of confirmed clinical or radiological progression (at Investigator's discretion) and/or unacceptable toxicity as per Investigator judgment during the line of therapy recommended by the MTB, the results of the second panel will be reviewed by MTB. Based on all genomics data available (i.e. randomized and 2nd panels), the MTB will recommend other treatment options. All results will be disclosed to Investigator in order to offer other treatment options.

Tracking Information

NCT #
NCT03163732
Collaborators
Roche Pharma AG
Investigators
Principal Investigator: Olivier Olivier, MD Centre Leon Berard