Molecular Screening for Cancer Treatment Optimization

Not Applicable

• Conditions: Metastatic Solid Tumors (Any Localization)
• Interventions: Procedure: Tumoral biopsy

• Registration Number: NCT01566019
• Lead Sponsor: Gustave Roussy, Cancer Campus, Grand Paris

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-10-28
• Study First Submitted: 2012-03-27
• Study First Submitted QC: 2012-03-28
• Study First Posted: 2012-03-29
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-14
• Last Update Posted: 2020-02-17
• Primary Completion: 2020-10
• Study Completion: 2020-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 2150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients with non curable metastatic cancer	Tumoral biopsy	-

Primary Outcome Measures

Name	Time	Method
Progression free survival (PFS) using a targeted treatment selected by molecular profiling compared to the PFS for the most recent regimen	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	Progression according to RECIST criteria or clinical progression or death of any cause

Secondary Outcome Measures

Name	Time	Method
Number of patient who received a targeted treatment oriented by molecular profiling	From the start to the end of enrollment, up to 3 years	Number of patient who received a targeted treatment oriented by molecular profiling
Progression free Survival, Overall Survival and Response Rate	Until progression, up to 1 year	Comparison of Progression Free Survival, Overall Survival and Response Rate between patients with targeted treatment and others enrolled patients.

Trial Locations

Locations (1)

Institut Gustave Roussy; 🇫🇷 Villejuif, Val De Marne, France