Clinical trial NCT01566019: Molecular Screening for Cancer Treatment Optimization
Official title: Molecular Screening Analysis Used as Decision Tool for Targeted Molecular Treatment
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Metastatic Solid Tumors (Any Localization)
Lead sponsor: Gustave Roussy, Cancer Campus, Grand Paris
Sponsor class: OTHER
First posted: 2012-03-29
Enrollment: 2150
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


Eligibility 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

Primary outcomes:
measure: Progression free survival (PFS) using a targeted treatment selected by molecular profiling compared to the PFS for the most recent regimen
timeFrame: 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 outcomes:
measure: Number of patient who received a targeted treatment oriented by molecular profiling
timeFrame: From the start to the end of enrollment, up to 3 years
measure: Progression free Survival, Overall Survival and Response Rate
timeFrame: Until progression, up to 1 year
Other outcomes:
Locations:
city: Villejuif
country: France
facility: Institut Gustave Roussy
state: Val De Marne
Study officials:
affiliation: Gustave Roussy, Cancer Campus, Grand Paris
name: Jean-Charles SORIA, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Martin-Romano P, Colmet-Daage L, Morel D, Baldini C, Verlingue L, Bahleda R, Gazzah A, Champiat S, Varga A, Michot JM, Ngo-Camus M, Nicotra C, Marabelle A, Soria JC, Rouleau E, Lacroix L, Hollebecque A, Massard C, Postel-Vinay S. Epigenetic gene alterations in metastatic solid tumours: results from the prospective precision medicine MOSCATO and MATCH-R trials. Eur J Cancer. 2022 Sep;173:133-145. doi: 10.1016/j.ejca.2022.06.014. Epub 2022 Jul 21.
citation: Verlingue L, Hollebecque A, Lacroix L, Postel-Vinay S, Varga A, El Dakdouki Y, Baldini C, Balheda R, Gazzah A, Michot JM, Marabelle A, Mir O, Arnedos M, Rouleau E, Solary E, De Baere T, Angevin E, Armand JP, Michiels S, Andre F, Deutsch E, Scoazec JY, Soria JC, Massard C. Human epidermal receptor family inhibitors in patients with ERBB3 mutated cancers: Entering the back door. Eur J Cancer. 2018 Mar;92:1-10. doi: 10.1016/j.ejca.2017.12.020. Epub 2018 Feb 3.
citation: Verlingue L, Malka D, Allorant A, Massard C, Ferte C, Lacroix L, Rouleau E, Auger N, Ngo M, Nicotra C, De Baere T, Tselikas L, Ba B, Michiels S, Scoazec JY, Boige V, Ducreux M, Soria JC, Hollebecque A. Precision medicine for patients with advanced biliary tract cancers: An effective strategy within the prospective MOSCATO-01 trial. Eur J Cancer. 2017 Dec;87:122-130. doi: 10.1016/j.ejca.2017.10.013. Epub 2017 Nov 14.
citation: Jovelet C, Ileana E, Le Deley MC, Motte N, Rosellini S, Romero A, Lefebvre C, Pedrero M, Pata-Merci N, Droin N, Deloger M, Massard C, Hollebecque A, Ferte C, Boichard A, Postel-Vinay S, Ngo-Camus M, De Baere T, Vielh P, Scoazec JY, Vassal G, Eggermont A, Andre 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.