The study will evaluate the efficacy of targeted therapy based on tumor molecular profiling versus conventional chemotherapy in patients with advanced cancer using each patient as its own control. This study is a study involving patients with advanced cancer. All types of solid tumors will be allowed in the study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SCREENING
Masking
NONE
Enrollment
170
The study will run in 2 steps. Before starting a new treatment, patients with advanced cancer will undergo a tumor biopsy of a metastatic site in order to perform molecular analyses seeking for druggable molecular alterations
Institut Bergonié
Bordeaux, France
Centre LEON BERARD
Lyon, France
Institut Curie
Paris, France
Institut Curie Hôpital René Huguenin
Saint-Cloud, France
Proportion of patients with a PFS2 to PFS1 ratio superior to 1.5.
PFS1 is defined as the time to a documented progression under conventional therapy according to RECIST 1.1. PFS2 is defined as the time to a documented progression or death when patients are treated by targeted therapy according to RECIST 1.1
Time frame: 3 years
Overall response rate (ORR) on both treatments
Evaluation of the best objective response rate (ORR) for each treatment according to RECIST 1.1 The best ORR is the best response reached during treatment according to RECIST 1.1 criteria.
Time frame: 3 years
Overall survival (OS)
Evaluation of overall survival (OS) defined as the time between inclusion and death, whatever the cause is. Alive patients will be censored at their last known contact date.
Time frame: 3 years
number of grade 3 or 4 adverse events and grade 1 or 2 adverse events that lead to dose modification or interruption
Evaluation of toxicities related to treatments according to CTCAE v4.03. Only grade 3 or 4 adverse events and grade 1 or 2 adverse events that lead to dose modification or interruption
Time frame: 3 years
Ability of ctDNA to detect molecular alterations identified on tumor biopsies
Percentage of patients for whom all druggable molecular alterations detected on the tumor biopsy are also detected on ctDNA.
Time frame: at baseline
Ability of fine-needle aspiration cytology to detect molecular alterations identified on tumor biopsies
Percentage of patients for whom all druggable molecular alterations detected on the tumor biopsy are also detected on fine-needle aspiration cytology
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Time frame: at baseline
Ability of sequential ctDNA sampling to predict response/resistance to treatment
Changes in ctDNA levels and molecular alterations observed at different time points.
Time frame: through study completion, every 2 months
Proportion of patients with a PFS2 to PFS1 ratio superior to 1.5, including patients who were treated with matched therapy based on a molecular alteration outside of RAF/MEK pathway
PFS1 is defined as the time to a documented progression under conventional therapy according to RECIST 1.1. PFS2 is defined as the time to a documented progression or death when patients are treated by targeted therapy according to RECIST 1.1
Time frame: 3 years