Bénéfice de la chimiothérapie périopératoire intensifiée chez les patients CINSARC à haut risque atteints de sarcomes des tissus mous résécables

Essai clinique

Type : Académique
Statut : Ouvert
Phase : III
Étape du traitement : Traitements combinés
Date d'ouverture : 14/02/2019
Date clôture : 28/02/2025
Promoteur : Institut Bergonié
Progression du cancer: Pas de progression
Résumé :

The primary objective of this trial is to investigate whether the addition of 3 additional neo-adjuvant cycles of chemotherapy (doxorubicin and ifosfamide) to standard management according to the ISG-STS 10-01 study (3 cycles of neoadjuvant doxorubicin and ifosfamide 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).

Domaines/spécialités :
  • Sarcomes (tissus mous et os)
Pathologies :
  • Tumeur maligne du tissu conjonctif et des autres tissus mous - Cim10 : C49
Liens externes :

Critères de population

Sexe : Homme et femme
Age minimum : 18 ans
Critères d’inclusion :
  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.
Critères d’exclusion :
  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 and Ifosfamide-based 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.

Centres d'investigation

En cours
Nom : Centre Georges François Leclerc - CGFL
Ville : DIJON (21)
RESPONSABLE MÉDICAL
Nom : Dr ISAMBERT
Prénom : Nicolas
Téléphone : Non disponible
Email : nisambert@cgfl.Fr
CONTACT TECHNIQUE
Nom : TURLOT
Prénom : Sandra
Téléphone : 03 80 73 77 52
Email : sturlot@cgfl.fr
En cours
Nom : ICANS
Ville : Strasbourg
RESPONSABLE MÉDICAL
Aucun responsable médical renseigné
CONTACT TECHNIQUE
Nom : Unité recherche clinique
Prénom : ICANS
Téléphone : Non disponible
Email : recherche-clinique@icans.eu

Référentiels Oncologik

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