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Molecular Screening for Cancer Treatment Optimization (MOSCATO 02)

This study is currently recruiting participants.
Verified July 2016 by Gustave Roussy, Cancer Campus, Grand Paris
Sponsor:
ClinicalTrials.gov Identifier:
NCT01566019
First Posted: March 29, 2012
Last Update Posted: July 12, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Gustave Roussy, Cancer Campus, Grand Paris
  Purpose

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.


Condition Intervention
Metastatic Solid Tumors (Any Localization) Procedure: Tumoral biopsy

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Molecular Screening Analysis Used as Decision Tool for Targeted Molecular Treatment

Further study details as provided by Gustave Roussy, Cancer Campus, Grand Paris:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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

  • 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.


Estimated Enrollment: 1050
Study Start Date: October 2011
Estimated Study Completion Date: October 2019
Estimated Primary Completion Date: October 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Patients with non curable metastatic cancer Procedure: Tumoral biopsy
Every enrolled patient undergoes tumoral biopsy

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   6 Months and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01566019


Locations
France
Institut Gustave Roussy Recruiting
Villejuif, Val de Marne, France, 94805
Contact: Jean-Charles SORIA, MD, PhD    +33 1 42 11 42 96    soria@igr.fr   
Contact: Christophe MASSARD, MD    +33 04 42 11 52 10    christophe.massard@igr.fr   
Principal Investigator: Jean-Charles SORIA, MD, PhD         
Sponsors and Collaborators
Gustave Roussy, Cancer Campus, Grand Paris
Investigators
Principal Investigator: Jean-Charles SORIA, MD, PhD Gustave Roussy, Cancer Campus, Grand Paris
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Gustave Roussy, Cancer Campus, Grand Paris
ClinicalTrials.gov Identifier: NCT01566019     History of Changes
Other Study ID Numbers: 2011-A00841-40
2011/1755 ( Other Identifier: CSET number )
First Submitted: March 27, 2012
First Posted: March 29, 2012
Last Update Posted: July 12, 2016
Last Verified: July 2016