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Study identifier: NCT04307277 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

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

Condition: Soft Tissue Sarcoma  ·  Sponsor: Institut Claudius Regaud

PhasePhase 3
Planned participants600
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Thibaud VALENTIN  ·  05 31 15 51 70  ·  valentin.thibaud@iuct-oncopole.fr

Always discuss trial participation with your own doctor first.

Locations (19)

CHRU BesançonBesançon, FranceRecruiting
Centre François BaclesseCaen, FranceRecruiting
Centre Jean PerrinClermont-Ferrand, FranceRecruiting
Centre Georges-François LeclercDijon, FranceRecruiting
CHU LimogesLimoges, FranceRecruiting
Centre Léon BérardLyon, FranceRecruiting
Institut Paoli-CalmettesMarseille, FranceRecruiting
CHU MarseilleMarseille, FranceRecruiting
Institut de Cancérologie de MontpellierMontpellier, FranceRecruiting
Centre Antoine LacassagneNice, FranceRecruiting
Hôpital CochinParis, FranceRecruiting
CHU PoitiersPoitiers, FranceRecruiting

+ 7 more locations — full list on the registry record.

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Source record: clinicaltrials.gov/study/NCT04307277