Informations générales (source: ClinicalTrials.gov)
Interest of Peri Operative CHemotherapy In Patients With CINSARC High-risk Localized Soft Tissue Sarcoma (CHIC-STS01)
Interventional
Phase 3
Institut Claudius Regaud (Voir sur ClinicalTrials)
octobre 2020
octobre 2032
05 avril 2025
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.
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| AP-HP - Hôpital Cochin | Pascaline BOUDOU-ROUQUETTE | Contact (sur clinicalTrials) | |||
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre François Baclesse - Caen - France | Zoé NEVIERE | Contact (sur clinicalTrials) | |||
| Centre Georges-François Leclerc - Dijon - France | Alice HERVIEU | Contact (sur clinicalTrials) | |||
| Centre Jean Perrin - Clermont-Ferrand - France | Pascale DUBRAY-LONGERAS | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre Antoine Lacassagne - 06189 - Nice - France | Esma SAADA-BOUZID | Contact (sur clinicalTrials) | |||
| Centre Eugène Marquis - 35042 - Rennes - France | Angélique BRUNOT | Contact (sur clinicalTrials) | |||
| Centre Henri Becquerel - 76038 - Rouen - France | Cécile GUILLEMET | Contact (sur clinicalTrials) | |||
| Centre Léon Bérard - Lyon - France | Armelle DUFRESNE | Contact (sur clinicalTrials) | |||
| CHRU Besançon - Besançon - France | Loïc CHAIGNEAU | Contact (sur clinicalTrials) | |||
| CHU de SAINT ETIENNE - Saint-Étienne - France | Contact (sur clinicalTrials) | ||||
| CHU Grenoble - Grenoble - France | Mathieu LARAMAS | Contact (sur clinicalTrials) | |||
| CHU Limoges - Limoges - France | Valérie LE BRUN-LY | Contact (sur clinicalTrials) | |||
| CHU Marseille - Marseille - France | Florence DUFFAUD | Contact (sur clinicalTrials) | |||
| CHU Poitiers - Poitiers - France | Nicolas ISAMBERT | Contact (sur clinicalTrials) | |||
| Institut Bergonié - Bordeaux - France | Antoine ITALIANO | Contact (sur clinicalTrials) | |||
| Institut de Cancérologie de Lorraine - Centre Alexis Vautrin - Vandœuvre-lès-Nancy - France | Maria RIOS | Contact (sur clinicalTrials) | |||
| Institut de Cancérologie de l'Ouest - Saint-Herblain - France | Emmanuelle BOMPAS | Contact (sur clinicalTrials) | |||
| Institut de Cancérologie de Montpellier - Montpellier - France | Nelly FIRMIN | Contact (sur clinicalTrials) | |||
| Institut de Cancérologie Strasbourg Europe - Strasbourg - France | Justine GANTZER | Contact (sur clinicalTrials) | |||
| Institut Godinot - Reims - France | Pauline SOIBINET-OUDOT | Contact (sur clinicalTrials) | |||
| Institut Paoli-Calmettes - 13273 - Marseille - France | François BERTUCCI | Contact (sur clinicalTrials) | |||
| Institut Universitaire du Cancer Toulouse Oncopole - Toulouse - France | Thibaud VALENTIN | Contact (sur clinicalTrials) | |||
Critères
Tous
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. 6 weeks or less between surgical excision and inclusion (if performed before
inclusion)
5. Available archived FFPE tumor sample in sufficient quantity to allow CINSARC
qualification
6. Age ≥ 18 years
7. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
8. Life expectancy of at least 12 weeks after the start of the treatment
9. 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.
10. Signed written informed consent
11. Patient affiliated to a Social Health Insurance in France.
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. 6 weeks or less between surgical excision and inclusion (if performed before
inclusion)
5. Available archived FFPE tumor sample in sufficient quantity to allow CINSARC
qualification
6. Age ≥ 18 years
7. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
8. Life expectancy of at least 12 weeks after the start of the treatment
9. 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.
10. Signed written informed consent
11. Patient affiliated to a Social Health Insurance in France.
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 surgical
excision)
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 prior randomization): Absolute
neutrophil count (ANC) ≥ 1.5 G/L, Platelet count ≥ 100 G/L and Hemoglobin > 9g/dL
3. Acceptable renal function within 72 hours prior randomization: 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