Actively Recruiting
Interest of Peri Operative CHemotherapy In Patients With CINSARC High-risk Localized Soft Tissue Sarcoma
Led by Institut Claudius Regaud · Updated on 2026-04-14
600
Participants Needed
19
Research Sites
625 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Phase III, multicenter, randomized open-label and comparative study designed to demonstrate whether adding 4 cycles of peri-operative doxorubicin-based chemotherapy improves metastasis-free survival as compared with standard management in patients with resectable STS, considered as high-risk according to CINSARC (Complexity Index in SARComas) signature. After signed informed consent, patients considered as eligible to CHIC-STS study by the investigator will be enrolled in the study and a molecular screening will be performed (600 patients will be screened). Patients considered as low-risk according to CINSARC signature will be treated at the discretion of the clinicians (prospective cohort). Patients considered as high-risk according to CINSARC signature will be randomized in the open-label multicenter phase III trial and assigned in one of the two following treatments arms: * Arm A (control arm): Standard of care (surgical excision +/- external radiotherapy). * Arm B (experimental arm): Standard of care + 4 cycles of intravenous chemotherapy during 12 weeks. A total of 250 patients will have to be randomized with 125 patients in each arm.
CONDITIONS
Official Title
Interest of Peri Operative CHemotherapy In Patients With CINSARC High-risk Localized Soft Tissue Sarcoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of soft-tissue sarcoma confirmed by the specialized pathology network
- Tumors graded 1, 2, or 3 according to the FNCLCC system
- Resectable and localized disease confirmed by appropriate examinations including chest CT
- Surgical excision within 6 weeks before inclusion if performed prior
- Availability of archived tumor sample sufficient for CINSARC testing
- Age 18 years or older
- ECOG performance status of 0, 1, or 2
- Life expectancy of at least 12 weeks from treatment start
- Women are post-menopausal or willing to use effective contraception during treatment and for specified periods after
- Negative pregnancy test within 72 hours before registration for non-menopausal women
- Men agree to use effective contraception during treatment and for at least 3 months after
- Signed informed consent
- Affiliated with Social Health Insurance in France
You will not qualify if you...
- Histological subtypes excluded: well-differentiated liposarcomas, alveolar soft-part sarcoma, dermatofibrosarcoma protuberans, clear-cell sarcoma, epithelioid sarcoma, alveolar or embryonal rhabdomyosarcoma
- Primitive cutaneous, retroperitoneal, uterine, or visceral soft tissue sarcomas
- Metastatic disease
- Prior or ongoing sarcoma treatment except surgical excision
- Contraindications to doxorubicin, ifosfamide, or dacarbazine
- Previous treatment with ifosfamide, cyclophosphamide, other nitrogen mustards, or anthracyclines
- Prior mediastinal or cardiac radiotherapy
- Significant cardiovascular conditions such as uncontrolled hypertension, severe heart failure, unstable angina, arrhythmia, or recent heart attack
- Other malignant diseases diagnosed or treated within the last 2 years except certain in situ carcinomas
- Active infections requiring systemic therapy
- Known HIV, hepatitis B, or hepatitis C infection
- Women who are pregnant, breastfeeding, or planning pregnancy during the trial
- Medical conditions that could interfere with study conduct or pose unacceptable risk
- Legal restrictions on freedom or inability to comply with the study protocol
- Additional criteria for randomized phase: high-risk CINSARC signature and acceptable blood, kidney, liver, and heart function according to specified laboratory values and tests
AI-Screening
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Trial Site Locations
Total: 19 locations
1
CHRU Besançon
Besançon, France
Actively Recruiting
2
Centre François Baclesse
Caen, France
Actively Recruiting
3
Centre Jean Perrin
Clermont-Ferrand, France
Actively Recruiting
4
Centre Georges-François Leclerc
Dijon, France
Actively Recruiting
5
CHU Limoges
Limoges, France
Actively Recruiting
6
Centre Léon Bérard
Lyon, France
Actively Recruiting
7
Institut Paoli-Calmettes
Marseille, France, 13273
Actively Recruiting
8
CHU Marseille
Marseille, France
Actively Recruiting
9
Institut de Cancérologie de Montpellier
Montpellier, France
Actively Recruiting
10
Centre Antoine Lacassagne
Nice, France, 06189
Actively Recruiting
11
Hôpital Cochin
Paris, France
Actively Recruiting
12
CHU Poitiers
Poitiers, France
Actively Recruiting
13
Institut Godinot
Reims, France
Actively Recruiting
14
Centre Eugène Marquis
Rennes, France, 35042
Actively Recruiting
15
Centre Henri Becquerel
Rouen, France, 76038
Actively Recruiting
16
Institut de Cancérologie de l'Ouest
Saint-Herblain, France
Actively Recruiting
17
Hôpitaux Universitaires de Strasbourg
Strasbourg, France
Actively Recruiting
18
Institut Universitaire du Cancer Toulouse Oncopole
Toulouse, France
Actively Recruiting
19
Institut de Cancérologie de Lorraine - Centre Alexis Vautrin
Vandœuvre-lès-Nancy, France
Actively Recruiting
Research Team
T
Thibaud VALENTIN
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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