Actively Recruiting
Benefit of Intensified Peri-operative Chemotherapy Within High-risk CINSARC Patients With Resectable Soft-tissue Sarcomas
Led by Institut Bergonié · Updated on 2025-10-02
351
Participants Needed
10
Research Sites
511 weeks
Total Duration
On this page
Sponsors
I
Institut Bergonié
Lead Sponsor
N
Novartis
Collaborating Sponsor
AI-Summary
What this Trial Is About
The primary objective of this trial is to investigate whether the addition of 3 additional neo-adjuvant cycles of chemotherapy (doxorubicin based chemotherapy) to standard management according to the ISG-STS 10-01 study (3 cycles of neoadjuvant doxorubicin based chemotherapy + surgery +/- radiotherapy) improves the outcome of high-risk CINSARC patients with resectable soft-tissue sarcoma (STS). Primary endpoint is metastatic progression-free survival (M-PFS, after 3 years of follow-up).
CONDITIONS
Official Title
Benefit of Intensified Peri-operative Chemotherapy Within High-risk CINSARC Patients With Resectable Soft-tissue Sarcomas
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed soft-tissue sarcoma as recommended by the French NCI
- Grade 2 or 3 tumor according to FNCLCC grading
- Archived tumor sample available for research
- Non-metastatic and surgically removable disease
- No prior treatment for this disease
- Age 18 years or older
- Life expectancy of at least 3 months
- ECOG performance status 0 or 1
- Measurable disease with lesions at least 10 mm or 15 mm if lymph nodes
- Negative pregnancy test for women of childbearing potential
- Use of medically acceptable contraception during treatment and for one year after
- Signed informed consent
- Social security compliant with French law
You will not qualify if you...
- Soft-tissue sarcoma subtypes: well-differentiated liposarcoma, alveolar soft-part sarcoma, dermatofibrosarcoma protuberans, clear-cell sarcoma, embryonal or alveolar rhabdomyosarcoma
- Other malignant diseases diagnosed or treated in last 2 years except certain treated in situ carcinomas
- Contraindications to anthracycline, ifosfamide, or dacarbazine chemotherapy
- Participation in another therapeutic study in last 28 days
- Known HIV, hepatitis B, or hepatitis C infection
- Pregnant or breastfeeding women
- Medical conditions interfering with study participation
- Individuals deprived of liberty or under legal guardianship
- Inability or unwillingness to comply with study protocol
AI-Screening
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Trial Site Locations
Total: 10 locations
1
Institut Bergonie
Bordeaux, France, 33076
Actively Recruiting
2
Centre Georges François Leclerc
Dijon, France, 21079
Actively Recruiting
3
CHU Dupuytren
Limoges, France, 87042
Actively Recruiting
4
Centre Léon Bérard
Lyon, France, 69373
Actively Recruiting
5
Institut Paoli Calmettes
Marseille, France, 13273
Actively Recruiting
6
Insitut du Cancer
Montpellier, France, 34298
Actively Recruiting
7
Institut de Cancérologie de l'Ouest - Site René Gauducheau
Saint-Herblain, France, 44805
Actively Recruiting
8
CHRU Strasbourg
Strasbourg, France, 67200
Actively Recruiting
9
Institut Claudius Regaud
Toulouse, France, 31052
Actively Recruiting
10
Institut Gustave Roussy
Villejuif, France, 94800
Not Yet Recruiting
Research Team
A
Antoine ITALIANO, MD, PhD
CONTACT
S
Simone MATHOULIN-PELISSIER, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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