Interest of Peri Operative CHemotherapy In Patients With CINSARC High-risk Localized Grade 1 or 2 Soft Tissue Sarcoma

  • STATUS
    Recruiting
  • End date
    Mar 11, 2025
  • participants needed
    600
  • sponsor
    Institut Claudius Regaud
Updated on 11 November 2020
Investigator
Thibaud VALENTIN, MD
Primary Contact
Institut de Canc rologie de la Loire (0.0 mi away) Contact
+17 other location
platelet count
doxorubicin
kidney function tests
metastasis
cancer chemotherapy
dacarbazine
ifosfamide
soft tissue sarcoma
leiomyosarcoma

Summary

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 FNCLCC grade 1/2 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.

Details
Treatment Standard of Care, Standard of care + chemotherapy
Clinical Study IdentifierNCT04307277
SponsorInstitut Claudius Regaud
Last Modified on11 November 2020

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Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have any of these conditions: Sarcoma or Connective and Soft Tissue Neoplasm or Sarcoma (Pediatric) or Soft Tissue Sarcoma or All Solid Tumors or Solid Tumors?
Do you have any of these conditions: Connective and Soft Tissue Neoplasm or Sarcoma or Soft Tissue Sarcoma or Sarcoma (Pediatric) or All Solid Tumors or sarcomas or soft tissue sarcomas o...?
Diagnosis of soft-tissue sarcoma, histologically confirmed by RRePS (Rseau de Rfrence en Pathologie des Sarcomes et des Viscres) network
According to FNCLCC grading system, grade 2 and grade 1 tumors
Resectable and localized disease after appropriate extension work-up (including at least a chest-CT)
Available archived FFPE tumor sample in sufficient quantity to allow CINSARC qualification
Age 18 years
Eastern Cooperative Oncology Group (ECOG) performance status 2
Life expectancy of at least 12 weeks after the start of the treatment
Women should be post-menopaused or willing to accept the use of an effective contraceptive regimen during the treatment period and at least 12 months after the end of the treatment period. All non-menopaused women should have a negative pregnancy test within 72 hours prior to registration
Signed written informed consent
Patient affiliated to a Social Health Insurance in France

Exclusion Criteria

Soft-tissue sarcoma with the following histological subtypes: well-differentiated liposarcomas, alveolar soft-part sarcoma, dermatofibrosarcoma protuberans, clear-cell sarcoma, epithelioid sarcoma, alveolar or embryonal rhabdomyosarcoma
Primitive cutaneous, retroperitoneal, uterus or visceral STS
Metastatic disease
Previous or ongoing treatment for the sarcoma (with the exception of a surgery for diagnosis intend)
Contra-indication for Doxorubicin, Ifosfamide and Dacarbazine treatments
Prior therapy with ifosfamide or cyclophosphamide or other nitrogen mustards, and prior therapy with anthracyclines
Prior mediastinal/cardiac radiotherapy
History or presence of clinically relevant cardiovascular abnormalities such as uncontrolled hypertension, congestive heart failure NYHA classification of 3, unstable angina or poorly controlled arrhythmia, myocardial infarction within 6 months prior to study entry
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
Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy
Known infection with HIV, hepatitis B, or hepatitis C
Women who are breastfeeding, pregnant or who plan to become pregnant while in the trial
Concomitant disease or condition that could interfere with the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to the subject in this study
Patient who has forfeited his/her freedom by administrative or legal award or who is under legal protection (curatorship and guardianship, protection of justice)
Patient unable to comply with the protocol for any reason
ADDITIONAL CRITERIA FOR THE RANDOMIZED PHASE III STUDY
High-risk CINSARC signature
External radiotherapy not initiated before randomization (if applicable)
Acceptable hematologic function (within 72 hours of eligibility assessment): Absolute neutrophil count (ANC) 1.5 G/L, Platelet count 100 G/L and Hemoglobin > 9g/dL
Acceptable renal function within 72 hours of eligibility assessment: Serum creatinine 1.5 x ULN or calculated creatinine clearance 60 mL/min (by the Cockcroft and Gault formula)
Acceptable liver function: Bilirubin 1.5 x upper limit of normal (ULN), AST (SGOT) and ALT (SGPT) 2.5 x ULN
Normal LVEF (>50%) measured by echocardiography or isotopic ventriculography
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