At a glance
ClinicalIndex Comparison Record- ✓Age ≥18 years
- ✓Soft tissue sarcoma with lung metastases, not suitable for metastasectomy
- ✓Disease progression within 6 months prior to entry
- ✓Maximum 2 prior systemic chemotherapy lines, trabectedin excluded
- ✕Prior treatment with trabectedin or radiotherapy (except if compatible with study radiotherapy)
- ✕ECOG performance status ≥2
- ✕Bilirubin >UNL
- ✕Creatinine >1.6 mg/dL
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase I-II Prospective Trial, Multicenter, Open Label, Exploring the Combination of Trabectedin Plus Radiotherapy in Soft Tissue Sarcoma Patients
In Brief
A Phase 2 clinical trial evaluating Trabectedin and Radiotherapy for Liposarcoma, Myxoid and 4 related conditions. Currently recruiting, targeting 199 participants across 17 sites in 3 countries.
Detailed 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.
Study Details
Timeline
Interventions
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.
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).