Molecular Screening for Cancer Treatment Optimization (MOSCATO 02)
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ClinicalTrials.gov Identifier: NCT01566019 |
Recruitment Status : Unknown
Verified February 2020 by Gustave Roussy, Cancer Campus, Grand Paris.
Recruitment status was: Recruiting
First Posted : March 29, 2012
Last Update Posted : February 17, 2020
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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 or disease | Intervention/treatment | Phase |
---|---|---|
Metastatic Solid Tumors (Any Localization) | Procedure: Tumoral biopsy | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 2150 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Other |
Official Title: | Molecular Screening Analysis Used as Decision Tool for Targeted Molecular Treatment |
Actual Study Start Date : | October 28, 2011 |
Estimated Primary Completion Date : | October 2020 |
Estimated Study Completion Date : | October 2020 |
Arm | Intervention/treatment |
---|---|
Experimental: Patients with non curable metastatic cancer |
Procedure: Tumoral biopsy
Every enrolled patient undergoes tumoral biopsy |
- 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
- 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.

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

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
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 |
Principal Investigator: | Jean-Charles SORIA, MD, PhD | Gustave Roussy, Cancer Campus, Grand Paris |
Responsible Party: | Gustave Roussy, Cancer Campus, Grand Paris |
ClinicalTrials.gov Identifier: | NCT01566019 |
Other Study ID Numbers: |
2011-A00841-40 2011/1755 ( Other Identifier: CSET number ) |
First Posted: | March 29, 2012 Key Record Dates |
Last Update Posted: | February 17, 2020 |
Last Verified: | February 2020 |