RecruitingPhase 3NCT04307277

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


Sponsor

Institut Claudius Regaud

Enrollment

600 participants

Start Date

Oct 9, 2020

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether giving chemotherapy before and after surgery (called perioperative chemotherapy) improves survival in patients with soft tissue sarcoma that is classified as high-risk based on a specific genetic test called CINSARC. **You may be eligible if...** - You have been diagnosed with soft tissue sarcoma confirmed by a specialist pathology network - Your sarcoma is localized (has not spread) and can be surgically removed - Your tumor has been classified as CINSARC high-risk - You are at least 18 years old with adequate physical function (ECOG performance status 0 or 2) - Surgery was performed no more than 6 weeks ago if done before enrollment - Your life expectancy is at least 12 weeks **You may NOT be eligible if...** - Your sarcoma has already spread to other organs - Your tumor cannot be surgically removed - You have serious heart, kidney, or liver problems - You are pregnant or breastfeeding - You have had prior chemotherapy for this sarcoma Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGStandard of care + chemotherapy

Doxorubicine with Ifosfamide during 4 cycles Q3W Or Doxorubicine with Dacarbazine during 4 cycles Q3W (for patients with Leiomyosarcoma)

OTHERStandard of care

Surgical excision with external radiotherapy (if applicable)


Locations(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, France

CHU Marseille

Marseille, France

Institut de Cancérologie de Montpellier

Montpellier, France

Centre Antoine Lacassagne

Nice, France

Hôpital Cochin

Paris, France

CHU Poitiers

Poitiers, France

Institut Godinot

Reims, France

Centre Eugène Marquis

Rennes, France

Centre Henri Becquerel

Rouen, 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

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NCT04307277


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