Interest of Peri Operative CHemotherapy In Patients With CINSARC High-risk Localized Soft Tissue Sarcoma (CHIC-STS01)

February 26, 2024 updated by: Institut Claudius Regaud

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

600

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Besançon, France
      • Bordeaux, France
      • Caen, France
      • Clermont-Ferrand, France
      • Dijon, France
        • Recruiting
        • Centre Georges-François Leclerc
        • Contact:
      • Grenoble, France
      • Limoges, France
      • Lyon, France
      • Marseille, France, 13273
      • Marseille, France
      • Montpellier, France
      • Nice, France, 06189
      • Paris, France
        • Recruiting
        • Hôpital COCHIN
        • Contact:
      • Poitiers, France
      • Reims, France
      • Rennes, France, 35042
      • Rouen, France, 76038
      • Saint-Herblain, France
      • Saint-Étienne, France
        • Withdrawn
        • CHU de Saint Etienne
      • Strasbourg, France
        • Recruiting
        • Institut de cancerologie Strasbourg Europe
        • Contact:
      • Toulouse, France
      • Vandœuvre-lès-Nancy, France
        • Recruiting
        • Institut de Cancérologie de Lorraine - Centre Alexis Vautrin
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Diagnosis of soft-tissue sarcoma, histologically confirmed by RRePS (Réseau de Référence en Pathologie des Sarcomes et des Viscères) network.
  2. According to FNCLCC grading system, grade 1, 2 or 3 tumors.
  3. Resectable and localized disease after appropriate extension work-up (including at least a chest-CT).
  4. Available archived FFPE tumor sample in sufficient quantity to allow CINSARC qualification.
  5. Age ≥ 18 years.
  6. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
  7. Life expectancy of at least 12 weeks after the start of the treatment.
  8. 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.
  9. Signed written informed consent.
  10. Patient affiliated to a Social Health Insurance in France.

Exclusion Criteria:

  1. 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.
  2. Primitive cutaneous, retroperitoneal, uterus or visceral STS.
  3. Metastatic disease.
  4. Previous or ongoing treatment for the sarcoma (with the exception of a surgery for diagnosis intend).
  5. Contra-indication for Doxorubicin, Ifosfamide and Dacarbazine treatments.
  6. Prior therapy with ifosfamide or cyclophosphamide or other nitrogen mustards, and prior therapy with anthracyclines.
  7. Prior mediastinal/cardiac radiotherapy.
  8. 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.
  9. 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.
  10. Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy.
  11. Known infection with HIV, hepatitis B, or hepatitis C.
  12. Women who are breastfeeding, pregnant or who plan to become pregnant while in the trial.
  13. 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.
  14. Patient who has forfeited his/her freedom by administrative or legal award or who is under legal protection (curatorship and guardianship, protection of justice).
  15. Patient unable to comply with the protocol for any reason.

ADDITIONAL CRITERIA FOR THE RANDOMIZED PHASE III STUDY

  1. High-risk CINSARC signature.
  2. 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.
  3. 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).
  4. Acceptable liver function: Bilirubin ≤ 1.5 x upper limit of normal (ULN), AST (SGOT) and ALT (SGPT) ≤ 2.5 x ULN.
  5. Normal LVEF (>50%) measured by echocardiography or isotopic ventriculography .

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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)
Other: Control arm
Other: Standard of care
Surgical excision with external radiotherapy (if applicable)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Metastasis-free survival defined by the delay between randomization and the appearance of metastatic.
Time Frame: 5 years for each patient
5 years for each patient

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall survival defined by the delay between randomization and death from any cause.
Time Frame: 5 years for each patient
5 years for each patient
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
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
4 months for each patient

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut Claudius Regaud

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 9, 2020

Primary Completion (Estimated)

March 1, 2025

Study Completion (Estimated)

March 1, 2025

Study Registration Dates

First Submitted

March 11, 2020

First Submitted That Met QC Criteria

March 11, 2020

First Posted (Actual)

March 13, 2020

Study Record Updates

Last Update Posted (Actual)

February 28, 2024

Last Update Submitted That Met QC Criteria

February 26, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19SARC05

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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