RecruitingPhase 1Phase 2NCT02275286

Trabectedin Plus Radiotherapy in Soft Tissue Sarcoma Patients

Phase I-II Prospective Trial, Multicenter, Open Label, Exploring the Combination of Trabectedin Plus Radiotherapy in Soft Tissue Sarcoma Patients

Sponsor

Grupo Espanol de Investigacion en Sarcomas

Enrollment

199 participants

Start Date

Nov 1, 2014

Study Type

INTERVENTIONAL

Conditions

Liposarcoma, Myxoid

Summary

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing whether combining a chemotherapy drug called trabectedin with targeted radiation therapy can help treat soft tissue sarcoma (a rare cancer of muscles, fat, or connective tissues) or bone cancer (Ewing sarcoma) that has spread to the lungs. **You may be eligible if...** - You are 18 or older with a diagnosis of soft tissue sarcoma that has spread only to the lungs - Your cancer has progressed within the last 6 months - You have had no more than two prior treatment lines (and did not receive trabectedin before) - Your general health allows you to receive chemotherapy - You have certain acceptable types of sarcoma (e.g., liposarcoma, synovial sarcoma, leiomyosarcoma, etc.) **You may NOT be eligible if...** - Your cancer has spread beyond the lungs to more than one additional organ - You have already received trabectedin - You have serious heart, liver, or kidney problems - You are pregnant or breastfeeding - You have had more than two prior treatment lines for advanced disease 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

DRUGTrabectedin

Escalating or deescalating dose of 1.3 or 1.5mg/m2, i.v 24h, once every 3 weeks. Cohort A: unlimited cycles. Cohort B: 3 cycles. Cohort C: 3 cycles. Cohort D: cycles of trabectedin will be provided and patients will subsequently be evaluated for surgery.

RADIATIONRadiotherapy

3D conformal radiotherapy (3D-CRT) or intensity modulated radiotherapy (IMRT) providing: Cohort A: 30Gy in 10 fractions (3Gy/fraction). Cohort B: 45Gy in 25 fractions (1.8Gy/fraction). Cohort C: 45Gy in 25 fractions (1.8Gy/fraction). Cohort D: 45Gy in 25 fractions (1.8Gy/fraction).

Locations(17)

Institut Bergonié

Bordeaux, France

Centre Léon Berard

Lyon, France

Istituto Clinico Humanitas

Rozzano, Milan, Italy

Centro di Referimento Ocologico

Aviano, Italy

Istituto Ortopedico Rizzoli

Bologna, Italy

Candiolo Cancer Institute

Candiolo, Italy

Istituto Nazionale dei Tumori

Milan, Italy

Hospital Miguel Servet

Zaragoza, Aragon, Spain

Hospital Sant Pau

Barcelona, Catalonia, Spain

Hospital Son Espases

Palma de Mallorca, Mallorca, Spain

Hospital Universitario Canarias

San Cristóbal de La Laguna, Tenerife, Spain

Hospital Vall d'Hebrón

Barcelona, Spain

Hospital Puerta de Hierro

Madrid, Spain

Hospital Universitario Gregorio Marañón

Madrid, Spain

Hospital Uniersitario La Paz

Madrid, Spain

Jiménez Díaz Foundation University Hospital

Madrid, Spain

Hospital Virgen del Rocío

Seville, Spain

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NCT02275286