Benefit of Intensified Peri-operative Chemotherapy Within High-risk CINSARC Patients With Resectable Soft-tissue Sarcomas (CIRSARC)

  • STATUS
    Recruiting
  • End date
    Feb 10, 2025
  • participants needed
    351
  • sponsor
    Institut Bergonié
Updated on 4 October 2022

Summary

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).

Description

For high-risk CINSARC patients, this is a multicenter randomized two-arm phase III trial, with a ratio 1:1:

  • Arm A: standard management (3 cycles of neoadjuvant doxorubicin based chemotherapy + surgery +/- radiotherapy)
  • Arm B: experimental arm (6 cycles of neoadjuvant doxorubicin based chemotherapy + surgery +/- radiotherapy)

For low-risk CINSARC patients, this a multicenter prospective cohort with treatment at the discretion of the investigator.

Details
Condition Non-metastatic Soft-tissue Sarcoma, Resectable
Treatment ifosfamide, doxorubicin, At the discretion of the investigator, Ifosfamide or dacarbazine
Clinical Study IdentifierNCT03805022
SponsorInstitut Bergonié
Last Modified on4 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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
No prior treatment for the disease under study
Age ≥ 18 years
Life expectancy ≥ 3 months
Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 1
Patients must have measurable disease (lesion in previously irradiated field can be considered as measurable if progressive at inclusion according to RECIST 1.1) defined as per RECIST v1.1 with at least one lesion that can be measured in at least one dimension (longest diameter to be recorded) as ≥ 10 mm or ≥ 15mm in case of adenopathy
Women of childbearing potential must have a negative serum pregnancy test before study entry. Both women and men must agree to use a medically acceptable method of contraception throughout the treatment period and for one year after discontinuation of treatment. Acceptable methods of contraception include intrauterine device (IUD), oral contraceptive, subdermal implant and double barrier. Subjects of childbearing potential are those who have not been surgically sterilized (e.g., vasectomy for males and hysterectomy for females) or have not been free from menses for ≥ 1 year
Voluntarily signed and dated written informed consents prior to any study specific procedure
Patients with a social security in compliance with the French law

Exclusion Criteria

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
Known infection with HIV, hepatitis B, or hepatitis C
Females who are pregnant or breast-feeding
Other medical conditions may interfere with the conduct of the study and, in the judgment of the investigator, would make the patient inappropriate for entry into this study
Individuals deprived of liberty or placed under legal guardianship
Unwillingness or inability to comply with the study protocol for any reason
Additional criteria for randomization
High-risk CINSARC signature
No more than two cycle of neo-adjuvant anthracycline-based chemotherapy before randomization
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