GENETIC SEQUENCING FOR THE TREATMENT OF ADVANCED SOFT-TISSUE SARCOMAS

Phase 1

• Conditions: Adult patients with locally advanced/unresectable and/or metastatic soft-tissue sarcoma; MedDRA version: 20.0Level: SOCClassification code 10029104Term: Neoplasms benign, malignant and unspecified (incl cysts and polyps)System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 20.0Level: LLTClassification code 10039494Term: Sarcoma NOSSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2017-002851-27-FR
• Lead Sponsor: INSERM

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-09-24
• Last Update Posted: 10 June 2024

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 960

Inclusion Criteria

1) Age = 18 years,
2) Histology: soft-tissue sarcoma confirmed by the RRePS Network, as recommended by the French NCI,
3) Metastatic STS,
4) No previous systemic treatment for metastatic disease,
5) Eastern Cooperative Oncology Group (ECOG) performance status = 1,
6) Adequate hematological and metabolic functions:
a. Hemoglobin = 9 g/dl
b. Albumin = 30 g/dl
7) Measurable disease according to RECIST 1.1. At least one site of disease must be uni-dimensionally > 10 mm,
8) Availability of suitable frozen archive tumor material from a metastatic or advanced disease (not previously treated),
9) Archived FFPE block of specimen tumor sampling obtained anytime during disease development for research purpose,
10) Eligible to first-line standard chemotherapy regimen,
11) No prior or concurrent malignant disease diagnosed or treated in the last two years before inclusion, except for in situ carcinoma of the cervix and adequately treated basal cell or squamous cell carcinoma of the skin and prostate cancer,
12) Patient with a social security in compliance with the French law,
13) Voluntary signed and dated written informed consent prior to any study specific procedure (ICF1).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 768
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 192

Exclusion Criteria

1) Radiological evidence of symptomatic or progressive brain metastases,
2) Inability to swallow,
3) Major problem with intestinal absorption,
4) Previous allogeneic bone marrow transplant,
5) Evidence of severe or uncontrolled systemic disease (uncontrolled hypertension, active bleeding diatheses, or active Hepatitis B, C and HIV or active autoimmune disease),
6) Any condition which in the Investigator’s opinion makes it undesirable for the subject to participate in the trial or which would jeopardize compliance with the protocol,
7) Individuals deprived of liberty or placed under guardianship
8) Pregnant or breast feeding women,
9) Men or women refusing contraception,
10) Previous enrolment in the present study,
11) Any contraindication to first-line chemotherapy treatment.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified