Health Trials

About this trial

Phase I-II trial that combines trabectedin plus radiotherapy for tumor reduction response measure in four cohorts of patients:

Cohort A: Patients with diagnosis of non-operable or unresectable or not oncologically recommended metastasectomy of limited to lung metastases soft tissue sarcoma.

Cohort B: Patients with locally advanced resectable Myxoid Liposarcoma. Cohort C: Patients with retroperitoneal and resectable soft tissue sarcoma (liposarcoma and leiomyosarcoma).

Cohort D (Phase II only): Patients with well differentiated liposarcoma and G2 dedifferentiated liposarcoma (with less than 30% dedifferentiated component).

Phase I: escalating dose of 1.3 or 1.5 mg/m2. Phase I for cohort C: de-escalating dose of 1.5 or 1.3mg/m2 Radiotherapy for cohort A: 30Gy in 10 fractions (3Gy/fraction). Radiotherapy for cohort B: 45Gy in 25 fractions (1.8Gy/fraction). Radiotherapy for cohort C: 45Gy in 25 fractions (1.8Gy/fraction).

Radiotherapy for cohort D: 45Gy in 25 fractions (1.8Gy/fraction). A translational substudy is developed to analyse different biomarkers predictive value.

Cohorts A and B are closed to recruitment in 2023.

Eligibility criteria

Qualifiers

The patient must sign voluntarily the informed consent form before any study test is conducted that is not part of routine patient care.

Aged equal or over 18.

Patients must have a diagnostic of Soft Tissue Sarcoma with metastasis limited to lung, and not suitable for metastasectomy or surgery resection or not oncologically recommended metastasectomy.A centralized diagnostic will be performed, the tumor sample must be available and sent prior to inclusion.

Disease distribution allows meeting with normal tissue constraints of radiation therapy. Radiation oncologist must confirm this point.

Disqualifiers

Previous treatment with trabectedin or previous treatment with radiotherapy (except if previous radiotherapy treatment plus planned study radiotherapy treatment allow tissues constrains)

Performance status ≥ 2 (ECOG).

Plasma bilirubin > UNL.

Creatinine > 1.6 mg/dL.

Trial design

Treatments tested in this trial

  • Trabectedin
  • Radiotherapy

Treatment groups

199 Participants
are divided into 1 treatment group

Locations

17
France
Institut Bergonié33000, Bordeaux France
Centre Léon Berard Lyon France
Italy
Istituto Clinico Humanitas20089, RozzanoMilan, Italy
Centro di Referimento Ocologico33081, Aviano Italy

Sponsors and collaborators

Grupo Espanol de Investigacion en Sarcomas

Lead sponsor

Centre Leon Berard

Collaborator

Italian Sarcoma Group

Collaborator

Source ClinicalTrials.gov