Predictive value of tumor microenvironment on pathologic response to neoadjuvant chemotherapy in patients with undifferentiated pleomorphic sarcomas.
Jean Philippe Guegan, Nathan El Ghazzi, Julien Vibert...
https://pubmed.ncbi.nlm.nih.gov/39444039Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID02789384
Prognostic Value of the CINSARC Signature and Correlation With Chemotherapy Efficacy in Soft-tissue Sarcomas A Biomarker Study
Led by Institut Bergonié · Updated on 2025-12-02
205
Participants Needed
10
Research Sites
52 weeks
Total Duration
On this page
Sponsors
I
Institut Bergonié
Lead Sponsor
N
National Cancer Institute, France
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying patients with non-metastatic soft-tissue sarcomas (STS) who are considered for neoadjuvant chemotherapy by specialized sarcoma teams. This prospective observational biomarker study aims to validate the prognostic value of the CINSARC genetic signature and explore molecular factors that might predict how well tumors respond to chemotherapy. The study may also uncover changes linked to drug resistance and disease progression to improve future patient care. Participants will undergo biopsies and blood sample collections for genetic profiling, including tumor material either from new biopsies or archived samples. They will receive neoadjuvant anthracycline-based chemotherapy, including drugs like doxorubicin and ifosfamide, given in cycles every 21 days for up to six cycles before surgery. After chemotherapy, patients will have surgery and may receive radiotherapy as part of their standard treatment. During the study, researchers will assess tumor response to chemotherapy using imaging criteria and analyze tumor tissue after surgery to measure remaining cancer cells and other histological features. They will monitor adverse events related to biopsy and track outcomes such as metastasis-free survival and overall survival for up to three years. Patients will be followed closely for around six months during treatment and longer to evaluate long-term outcomes.
CONDITIONS
Brief Title
CINSARC Signature and Correlation With Hemotherapy Efficacy in Soft-tissue Sarcomas. A Biomarker Study.
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Histologically confirmed soft-tissue sarcoma by central review or confirmed by the RRePS Network
- Available frozen tumor tissue sample or consent to undergo a biopsy for research
- Non-metastatic disease planned for neoadjuvant chemotherapy to improve tumor control
- Age 18 years or older
- ECOG performance status 0 or 1
- Measurable disease by RECIST v1.1 outside previously irradiated areas
- Neoadjuvant anthracycline-based chemotherapy recommended by specialist team
- No prior or concurrent malignant disease in the past 2 years except certain treated in situ cancers
- Signed informed consent before any study procedures
- Social security compliant with French biomedical research laws
You will not qualify if you...
- Diagnosis other than soft-tissue sarcoma
- Histological subtypes: well-differentiated liposarcoma, alveolar soft-part sarcoma, dermatofibrosarcoma protuberans, clear-cell sarcoma, rhabdomyosarcoma
- Previous treatment for the sarcoma
- Contraindication to chemotherapy
- Participation in another interventional study within 30 days
- Previous enrollment in this study
- Pregnant or breastfeeding women
- Inability to comply with study procedures due to geographic, social, or psychological reasons
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Up to 6 cycles over approximately 18 weeks
Participants receive neoadjuvant anthracycline-based chemotherapy consisting of at least doxorubicin and ifosfamide delivered in cycles every 21 days for up to 6 cycles before surgery.
Visits every 21 days for chemotherapy administration, up to 6 cycles
Surgery and Immediate Post-operative Care
Duration - Surgery and immediate recovery period
Participants undergo surgery following completion of chemotherapy, with possible radiotherapy according to usual medical practices.
1 surgical procedure with post-operative care visits as needed
Follow-up
Duration - Up to 3 years
Participants are followed for assessment of treatment efficacy, tumor response, adverse events, and survival outcomes.
Periodic visits for outcome assessments during follow-up
Trial Site Locations
Total: 10 locations
1
Institut Bergonié
Bordeaux, France, 33076
Actively Recruiting
2
Centre Georges François Leclerc
Dijon, France, 21079
Actively Recruiting
3
Centre Oscar Lambret
Lille, France, 59020
Not Yet Recruiting
4
Centre Léon Bérard
Lyon, France, 69373
Actively Recruiting
5
Institut Paoli Calmettes
Marseille, France, 13273
Actively Recruiting
6
AP-HM _ Hôpital de la Timone
Marseille, France, 13385
Actively Recruiting
7
Institut de Cancérologie de l'Ouest
Nantes, France, 44805
Actively Recruiting
8
Institut Curie
Paris, France, 75005
Not Yet Recruiting
9
Institut Claudius Regaud - IUCT-0
Toulouse, France, 31052
Actively Recruiting
10
Institut Gustave Roussy
Villejuif, France, 94805
Not Yet Recruiting
Loading map...
Research Team
A
Antoine ITALIANO, MD,PhD
S
Simone MATHOULIN-PELISSIER, MD,PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here