Interest of Peri Operative CHemotherapy In Patients With CINSARC High-risk Localized Soft Tissue Sarcoma
CHIC-STS01
1 other identifier
interventional
600
1 country
19
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Oct 2020
Longer than P75 for phase_3
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 11, 2020
CompletedFirst Posted
Study publicly available on registry
March 13, 2020
CompletedStudy Start
First participant enrolled
October 9, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2032
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 1, 2032
April 14, 2026
April 1, 2026
12 years
March 11, 2020
April 9, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Metastasis-free survival defined by the delay between randomization and the appearance of metastatic.
5 years for each patient
Secondary Outcomes (3)
Disease-free survival defined by the delay between randomization and first relapse (local, regional, or distant) or death from any cause.
5 years for each patient
Safety assessed by the toxicity grading of the National Cancer Institute (NCI-CTCAE v5.0).
4 months for each patient
Overall survival defined by the delay between randomization and death from any cause.
5 years for each patient
Study Arms (2)
Control arm
OTHERExperimental arm
EXPERIMENTALInterventions
Doxorubicine with Ifosfamide during 4 cycles Q3W Or Doxorubicine with Dacarbazine during 4 cycles Q3W (for patients with Leiomyosarcoma)
Eligibility Criteria
You may qualify if:
- 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 (ifosfamide treatment) or 6 months (dacarbazine treatment) after the end of the treatment period. All non-menopaused women should have a negative pregnancy test within 72 hours prior to registration. Men should accept to use an effective contraception during treatment period and at least 3 months after the end of the study treatment.
- Signed written informed consent
- Patient affiliated to a Social Health Insurance in France.
You may not qualify if:
- 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 surgical excision)
- 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.
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (19)
CHRU Besançon
Besançon, France
Centre François Baclesse
Caen, France
Centre Jean Perrin
Clermont-Ferrand, France
Centre Georges-François Leclerc
Dijon, France
CHU Limoges
Limoges, France
Centre Léon Bérard
Lyon, France
Institut Paoli-Calmettes
Marseille, 13273, France
CHU Marseille
Marseille, France
Institut de Cancérologie de Montpellier
Montpellier, France
Centre Antoine Lacassagne
Nice, 06189, France
Hôpital Cochin
Paris, France
CHU Poitiers
Poitiers, France
Institut Godinot
Reims, France
Centre Eugène Marquis
Rennes, 35042, France
Centre Henri Becquerel
Rouen, 76038, France
Institut de Cancérologie de l'Ouest
Saint-Herblain, France
Hôpitaux Universitaires de Strasbourg
Strasbourg, France
Institut Universitaire du Cancer Toulouse Oncopole
Toulouse, France
Institut de Cancérologie de Lorraine - Centre Alexis Vautrin
Vandœuvre-lès-Nancy, France
Related Publications (1)
Filleron T, Le Guellec S, Chevreau C, Cabarrou B, Lesluyes T, Lodin S, Massoubre A, Mounier M, Poublanc M, Chibon F, Valentin T. Value of peri-operative chemotherapy in patients with CINSARC high-risk localized grade 1 or 2 soft tissue sarcoma: study protocol of the target selection phase III CHIC-STS trial. BMC Cancer. 2020 Jul 31;20(1):716. doi: 10.1186/s12885-020-07207-3.
PMID: 32736540BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 11, 2020
First Posted
March 13, 2020
Study Start
October 9, 2020
Primary Completion (Estimated)
October 1, 2032
Study Completion (Estimated)
October 1, 2032
Last Updated
April 14, 2026
Record last verified: 2026-04