Molecular Screening for Cancer Treatment Optimization

Gustave Roussy, Cancer Campus, Grand Paris2,150 enrolled

Overview

The primary objective of the study is to use high throughput molecular analysis (CGH Array and sequencing) to treat patients with metastatic cancer with targeted therapeutics in order to improve the progression free survival compared to the previous treatment line. The secondary objectives are to investigate clinical practical feasibility of such technics, to potentially improve the overall survival of patients and to describe molecular portrait of Phase 1 candidates.

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

2,150

Conditions

Metastatic Solid Tumors (Any Localization)

Interventions

Tumoral biopsyPROCEDURE

Every enrolled patient undergoes tumoral biopsy

Eligibility

Sex: ALLMin age: 6 Months

Medical Language ↔ Plain English

Inclusion Criteria: * Solid tumors ; Stade IV ; Local relapse or metastatic ; Uncurable * Age \> 6 months * PS 0/1 or Lansky play scale \>= 70% * Minimum one treatment line, no limit in the prior number of treatment line * Evaluable or measurable disease Exclusion Criteria: * Life expectancy \< 3 months * Carcinomatous meningitis * Symptomatic or progressive radiologic brain metastasis for non-CNS tumors * Polynuclear neutrophil \< 1 x 10\^9/L * Platelets \< 100 x 10\^9/L * Hemoglobin \< 90 g/L * ALT/AST \> 2.5 N * bilirubin \> 1.5 N * Creatinine \>1.5 N * Calcemia \> ULN * Phosphate \> ULN * Coagulation anomaly non-indicated for biopsy

Locations (1)

Institut Gustave Roussy

Villejuif, Val De Marne, France

RECRUITING

Outcomes

Primary Outcomes

Progression free survival (PFS) using a targeted treatment selected by molecular profiling compared to the PFS for the most recent regimen

Progression according to RECIST criteria or clinical progression or death of any cause

Time frame: From date of start of targeted treatment oriented by MOSCATO until the date of first progression or date of death from any cause, whichever came first, assessed up to 1 year

Secondary Outcomes

Number of patient who received a targeted treatment oriented by molecular profiling

Time frame: From the start to the end of enrollment, up to 3 years

Progression free Survival, Overall Survival and Response Rate

Comparison of Progression Free Survival, Overall Survival and Response Rate between patients with targeted treatment and others enrolled patients.

Time frame: Until progression, up to 1 year

Data from ClinicalTrials.gov

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