Condition: Soft Tissue Sarcoma · Sponsor: 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.
This description comes directly from the study's public registry record.
Thibaud VALENTIN · 05 31 15 51 70 · valentin.thibaud@iuct-oncopole.fr
Always discuss trial participation with your own doctor first.
| CHRU Besançon | Besançon, France | Recruiting |
| Centre François Baclesse | Caen, France | Recruiting |
| Centre Jean Perrin | Clermont-Ferrand, France | Recruiting |
| Centre Georges-François Leclerc | Dijon, France | Recruiting |
| CHU Limoges | Limoges, France | Recruiting |
| Centre Léon Bérard | Lyon, France | Recruiting |
| Institut Paoli-Calmettes | Marseille, France | Recruiting |
| CHU Marseille | Marseille, France | Recruiting |
| Institut de Cancérologie de Montpellier | Montpellier, France | Recruiting |
| Centre Antoine Lacassagne | Nice, France | Recruiting |
| Hôpital Cochin | Paris, France | Recruiting |
| CHU Poitiers | Poitiers, France | Recruiting |
+ 7 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT04307277