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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
March 27, 2012
March 29, 2012
July 12, 2016
October 2011
October 2019   (Final data collection date for primary outcome measure)
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
Progression free survival 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 death of any cause
Complete list of historical versions of study NCT01566019 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
Molecular Screening for Cancer Treatment Optimization
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.

Not Provided
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Metastatic Solid Tumors (Any Localization)
Procedure: Tumoral biopsy
Every enrolled patient undergoes tumoral biopsy
Experimental: Patients with non curable metastatic cancer
Intervention: Procedure: Tumoral biopsy
Jovelet C, Ileana E, Le Deley MC, Motté N, Rosellini S, Romero A, Lefebvre C, Pedrero M, Pata-Merci N, Droin N, Deloger M, Massard C, Hollebecque A, Ferté C, Boichard A, Postel-Vinay S, Ngo-Camus M, De Baere T, Vielh P, Scoazec JY, Vassal G, Eggermont A, André F, Soria JC, Lacroix L. Circulating Cell-Free Tumor DNA Analysis of 50 Genes by Next-Generation Sequencing in the Prospective MOSCATO Trial. Clin Cancer Res. 2016 Jun 15;22(12):2960-8. doi: 10.1158/1078-0432.CCR-15-2470. Epub 2016 Jan 12.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1050
October 2019
October 2019   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
6 Months and older   (Child, Adult, Senior)
No
France
 
 
NCT01566019
2011-A00841-40
2011/1755 ( Other Identifier: CSET number )
No
Not Provided
Not Provided
Gustave Roussy, Cancer Campus, Grand Paris
Gustave Roussy, Cancer Campus, Grand Paris
Not Provided
Principal Investigator: Jean-Charles SORIA, MD, PhD Gustave Roussy, Cancer Campus, Grand Paris
Gustave Roussy, Cancer Campus, Grand Paris
July 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP