Molecular Screening for Cancer Treatment Optimization (MOSCATO 02)

February 14, 2020 updated by: Gustave Roussy, Cancer Campus, Grand Paris

Molecular Screening Analysis Used as Decision Tool for Targeted Molecular Treatment

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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

2150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Val De Marne
      • Villejuif, Val De Marne, France, 94805
        • Recruiting
        • Institut Gustave Roussy
        • Contact:
          • Jean-Charles SORIA, MD, PhD
          • Phone Number: +33 1 42 11 42 96
          • Email: soria@igr.fr
        • Contact:
        • Principal Investigator:
          • Jean-Charles SORIA, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patients with non curable metastatic cancer
Procedure: Tumoral biopsy
Every enrolled patient undergoes tumoral biopsy

What is the study measuring?

Primary Outcome Measures

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

Outcome Measure
Measure Description
Time Frame
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
Number of patient who received a targeted treatment oriented by molecular profiling
From the start to the end of enrollment, up to 3 years
Progression free Survival, Overall Survival and Response Rate
Time Frame: 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.
Until progression, up to 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gustave Roussy, Cancer Campus, Grand Paris

Investigators

  • Principal Investigator: Jean-Charles SORIA, MD, PhD, Gustave Roussy, Cancer Campus, Grand Paris

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 28, 2011

Primary Completion (Anticipated)

October 1, 2020

Study Completion (Anticipated)

October 1, 2020

Study Registration Dates

First Submitted

March 27, 2012

First Submitted That Met QC Criteria

March 28, 2012

First Posted (Estimate)

March 29, 2012

Study Record Updates

Last Update Posted (Actual)

February 17, 2020

Last Update Submitted That Met QC Criteria

February 14, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • 2011-A00841-40
  • 2011/1755 (Other Identifier: CSET number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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