Benefit of Intensified Peri-operative Chemotherapy Within High-risk CINSARC Patients With Resectable Soft-tissue Sarcomas
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorInstitut Bergonié
About this trial
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).
Eligibility criteria
Qualifiers
Histologically confirmed soft-tissue sarcoma by the RRePS (Réseau de Référence en Pathologie des Sarcomes et des Viscères) network, as recommended by the French NCI,
Grade 2 or 3 according to the FNCLCC grading system,
Available archived tumour sample for research purpose,
Non-metastatic and resectable disease,
Disqualifiers
Soft-tissue sarcoma with the following histological subtypes: well-differentiated liposarcoma, alveolar soft-part sarcoma, dermatofibrosarcoma protuberans, clearcell sarcoma, embryonal and alveolar rhabdomyosarcoma,
Prior or concurrent malignant disease diagnosed or treated in the last 2 years except for adequately treated in situ carcinoma of the cervix, basal or squamous skin cell carcinoma, or in situ transitional bladder cell carcinoma,
Any other contraindication to anthracycline, ifosfamide or dacarbazine chemotherapy,
Participation to a study involving a medical or therapeutic intervention in the last 28 days,
Trial design
Treatments tested in this trial
- Doxorubicin
- Ifosfamide or dacarbazine
- Doxorubicin
- Ifosfamide or dacarbazine
- At the discretion of the investigator
Treatment groups
351 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov