Informations générales (source: ClinicalTrials.gov)
Phase III Trial Investigating the Potential Benefit of Intensified Peri-operative Chemotherapy With in High-risk CINSARC Patients With Resectable Soft-tissue SARComas (CIRSARC)
Interventional
Phase 3
Institut Bergonié (Voir sur ClinicalTrials)
février 2019
février 2025
08 février 2025
The primary objective of this trial is to investigate whether the addition of 3
additional neo-adjuvant cycles of chemotherapy (doxorubicin based chemotherapy) to
standard management according to the ISG-STS 10-01 study (3 cycles of neoadjuvant
doxorubicin based chemotherapy + surgery +/- radiotherapy) improves the outcome of
high-risk CINSARC patients with resectable soft-tissue sarcoma (STS). Primary endpoint is
metastatic progression-free survival (M-PFS, after 3 years of follow-up).
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | Axel LE CESNE | 19/02/2024 12:51:47 | Contacter | ||
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre Georges François Leclerc - 21079 - Dijon - France | Nicolas ISAMBERT | Contact (sur clinicalTrials) | |||
| CHU Dupuytren - 87042 - Limoges - France | Valérie LEBRUN-LY, MD | Contact (sur clinicalTrials) | |||
| Institut Bergonie - 33076 - Bordeaux - France | Antoine ITALIANO, MD, PhD | Contact (sur clinicalTrials) | |||
| Institut Claudius Regaud - 31052 - Toulouse - France | Christine CHEVREAU | 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 Léon Bérard - 69373 - Lyon Cedex 08 - France | Jean-Yves BLAY, MD, PhD | Contact (sur clinicalTrials) | |||
| CHRU Strasbourg - 67200 - Strasbourg - France | Jean-Emmanuel KURTZ, MD, PhD | Contact (sur clinicalTrials) | |||
| Insitut du Cancer - 34298 - Montpellier - France | Nelly FIRMIN, MD | Contact (sur clinicalTrials) | |||
| Institut de Cancérologie de l'Ouest - Site René Gauducheau - 44805 - Saint-Herblain - France | Emmanuelle BOMPAS, MD | Contact (sur clinicalTrials) | |||
| Institut Paoli Calmettes - 13273 - Marseille - France | François BERTUCCI, MD, PhD | Contact (sur clinicalTrials) | |||
Critères
Tous
Inclusion Criteria :
1. Histologically confirmed soft-tissue sarcoma by the RRePS (Réseau de Référence en
Pathologie des Sarcomes et des Viscères) network, as recommended by the French NCI,
2. Grade 2 or 3 according to the FNCLCC grading system,
3. Available archived tumour sample for research purpose,
4. Non-metastatic and resectable disease,
5. No prior treatment for the disease under study,
6. Age ≥ 18 years,
7. Life expectancy ≥ 3 months,
8. Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 1,
9. Patients must have measurable disease (lesion in previously irradiated field can be
considered as measurable if progressive at inclusion according to RECIST 1.1)
defined as per RECIST v1.1 with at least one lesion that can be measured in at least
one dimension (longest diameter to be recorded) as ≥ 10 mm or ≥ 15mm in case of
adenopathy,
10. Women of childbearing potential must have a negative serum pregnancy test before
study entry. Both women and men must agree to use a medically acceptable method of
contraception throughout the treatment period and for one year after discontinuation
of treatment. Acceptable methods of contraception include intrauterine device (IUD),
oral contraceptive, subdermal implant and double barrier. Subjects of childbearing
potential are those who have not been surgically sterilized (e.g., vasectomy for
males and hysterectomy for females) or have not been free from menses for ≥ 1 year,
11. Voluntarily signed and dated written informed consents prior to any study specific
procedure,
12. Patients with a social security in compliance with the French law.
Exclusion Criteria :
1. Soft-tissue sarcoma with the following histological subtypes: well-differentiated
liposarcoma, alveolar soft-part sarcoma, dermatofibrosarcoma protuberans, clearcell
sarcoma, embryonal and alveolar rhabdomyosarcoma,
2. 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,
3. Any other contraindication to anthracycline, ifosfamide or dacarbazine chemotherapy,
4. Participation to a study involving a medical or therapeutic intervention in the last
28 days,
5. Known infection with HIV, hepatitis B, or hepatitis C,
6. Females who are pregnant or breast-feeding,
7. Other medical conditions may interfere with the conduct of the study and, in the
judgment of the investigator, would make the patient inappropriate for entry into
this study,
8. Individuals deprived of liberty or placed under legal guardianship,
9. Unwillingness or inability to comply with the study protocol for any reason.
Additional criteria for randomization :
1. High-risk CINSARC signature,
2. No more than two cycle of neo-adjuvant anthracycline-based chemotherapy before
randomization.
1. Histologically confirmed soft-tissue sarcoma by the RRePS (Réseau de Référence en
Pathologie des Sarcomes et des Viscères) network, as recommended by the French NCI,
2. Grade 2 or 3 according to the FNCLCC grading system,
3. Available archived tumour sample for research purpose,
4. Non-metastatic and resectable disease,
5. No prior treatment for the disease under study,
6. Age ≥ 18 years,
7. Life expectancy ≥ 3 months,
8. Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 1,
9. Patients must have measurable disease (lesion in previously irradiated field can be
considered as measurable if progressive at inclusion according to RECIST 1.1)
defined as per RECIST v1.1 with at least one lesion that can be measured in at least
one dimension (longest diameter to be recorded) as ≥ 10 mm or ≥ 15mm in case of
adenopathy,
10. Women of childbearing potential must have a negative serum pregnancy test before
study entry. Both women and men must agree to use a medically acceptable method of
contraception throughout the treatment period and for one year after discontinuation
of treatment. Acceptable methods of contraception include intrauterine device (IUD),
oral contraceptive, subdermal implant and double barrier. Subjects of childbearing
potential are those who have not been surgically sterilized (e.g., vasectomy for
males and hysterectomy for females) or have not been free from menses for ≥ 1 year,
11. Voluntarily signed and dated written informed consents prior to any study specific
procedure,
12. Patients with a social security in compliance with the French law.
Exclusion Criteria :
1. Soft-tissue sarcoma with the following histological subtypes: well-differentiated
liposarcoma, alveolar soft-part sarcoma, dermatofibrosarcoma protuberans, clearcell
sarcoma, embryonal and alveolar rhabdomyosarcoma,
2. 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,
3. Any other contraindication to anthracycline, ifosfamide or dacarbazine chemotherapy,
4. Participation to a study involving a medical or therapeutic intervention in the last
28 days,
5. Known infection with HIV, hepatitis B, or hepatitis C,
6. Females who are pregnant or breast-feeding,
7. Other medical conditions may interfere with the conduct of the study and, in the
judgment of the investigator, would make the patient inappropriate for entry into
this study,
8. Individuals deprived of liberty or placed under legal guardianship,
9. Unwillingness or inability to comply with the study protocol for any reason.
Additional criteria for randomization :
1. High-risk CINSARC signature,
2. No more than two cycle of neo-adjuvant anthracycline-based chemotherapy before
randomization.