Interest of Peri Operative CHemotherapy In Patients With CINSARC High-risk Localized Soft Tissue Sarcoma (CHIC-STS01)
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| ClinicalTrials.gov Identifier: NCT04307277 |
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Recruitment Status :
Recruiting
First Posted : March 13, 2020
Last Update Posted : February 27, 2023
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Sponsor:
Institut Claudius Regaud
Information provided by (Responsible Party):
Institut Claudius Regaud
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Brief 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 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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Soft Tissue Sarcoma | Drug: Standard of care + chemotherapy Other: Standard of care | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 600 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Interest of Peri Operative CHemotherapy In Patients With CINSARC High-risk Localized Soft Tissue Sarcoma |
| Actual Study Start Date : | October 9, 2020 |
| Estimated Primary Completion Date : | March 2025 |
| Estimated Study Completion Date : | March 2025 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Soft Tissue Sarcoma
| Arm | Intervention/treatment |
|---|---|
| Control arm |
Other: Standard of care
Surgical excision with external radiotherapy (if applicable) |
| Experimental: Experimental arm |
Drug: Standard of care + chemotherapy
Doxorubicine with Ifosfamide during 4 cycles Q3W Or Doxorubicine with Dacarbazine during 4 cycles Q3W (for patients with Leiomyosarcoma) |
Primary Outcome Measures :
- Metastasis-free survival defined by the delay between randomization and the appearance of metastatic. [ Time Frame: 5 years for each patient ]
Secondary Outcome Measures :
- Disease-free survival defined by the delay between randomization and first relapse (local, regional, or distant) or death from any cause. [ Time Frame: 5 years for each patient ]
- Safety assessed by the toxicity grading of the National Cancer Institute (NCI-CTCAE v5.0). [ Time Frame: 4 months for each patient ]
- Overall survival defined by the delay between randomization and death from any cause. [ Time Frame: 5 years for each patient ]
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Diagnosis of soft-tissue sarcoma, histologically confirmed by RRePS (Réseau de Référence en Pathologie des Sarcomes et des Viscères) network.
- According to FNCLCC grading system, grade 1, 2 or 3 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.
- 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 .
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04307277
Contacts
| Contact: Thibaud VALENTIN | 05 31 15 51 70 | valentin.thibaud@iuct-oncopole.fr |
Locations
Show 22 study locations
Sponsors and Collaborators
Institut Claudius Regaud
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Institut Claudius Regaud |
| ClinicalTrials.gov Identifier: | NCT04307277 |
| Other Study ID Numbers: |
19SARC05 |
| First Posted: | March 13, 2020 Key Record Dates |
| Last Update Posted: | February 27, 2023 |
| Last Verified: | February 2023 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Institut Claudius Regaud:
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Soft Tissue Sarcoma CINSARC signature Chemotherapy |
Additional relevant MeSH terms:
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Sarcoma Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type Neoplasms |