Phase I-II prospective trial, multicenter, open label, exploring the combination of Trabectedin plus RAdiotherapy in Soft Tissue Sarcoma patients

Status

Not yet recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-518199-30-00

Enrollment

163

Registered

2024-11-25

Start date

Unknown

Completion date

Unknown

Last updated

2024-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Soft tissue sarcoma patients

Brief summary

To determine the maximum tolerated dose (MTD) or the recommended phase II dose of trabectedin for the combination with radiation therapy. RECIST response for the combination of trabectedin plus radiation therapy in cohorts A, B. CHOI response for the combination of trabectedin plus radiation therapy in cohort C. In cohort D to improve 5-year relapse-free survival (RFS), decreasing the 5-year relapse percentage from 30% to 10% in cohort D patients.

Interventions

DRUGYondelis 1 mg powder for concentrate for solution for infusion.

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
To determine the maximum tolerated dose (MTD) or the recommended phase II dose of trabectedin for the combination with radiation therapy. RECIST response for the combination of trabectedin plus radiation therapy in cohorts A, B. CHOI response for the combination of trabectedin plus radiation therapy in cohort C. In cohort D to improve 5-year relapse-free survival (RFS), decreasing the 5-year relapse percentage from 30% to 10% in cohort D patients.	—

Measure

Time frame

—

Countries

France, Italy, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026