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Multicohort Trial of Trabectedin and Low-dose Radiation Therapy in Advanced/Metastatic Sarcomas

NCT05131386 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 85

Last updated 2023-03-27

No results posted yet for this study

Summary

Phase II, multicohort, single arm, open-label, multicenter, international clinical trial with three cohorts (cohort A: Soft tissue sarcoma, cohort B: Bone tumors (osteosarcoma, chondrosarcoma and cohort C: Small round-cell sarcomas (Ewing's sarcoma, rhabdomyosarcoma, desmoplastic small round-cell tumors and other small round cell sarcomas)) with 7 sites in Spain.

Main objective: To evaluate the overall response rate (ORR) in the irradiated nodules according to RECIST v1.1 criteria.

Treatment

Medication

Trabectedin at 1.5 mg/m2 24-h IV CI along with radiation therapy (30 Gy, 3 Gy/day for 10 days for non-extremity location and 45 Gy, 1.8 Gy/day for 25 days for extremity location of target lesion(s)), starting within 1 hour after the first trabectedin infusion withdrawal (day 2)) will be given every 3 weeks up to progression or intolerance.

Premedication

4 mg oral dexamethasone 24h and 12h before trabectedin administration, 20 mg IV dexamethasone 30 minutes before treatment. Ondansetron or analogue will also be given prior to trabectedin.

Conditions

  • Soft Tissue Sarcoma
  • Bone Tumors
  • Small Round-cell Sarcomas

Interventions

DRUG

Trabectedin

ET-743, Yondelis (vials of 1 mg). Route of administration: intravenous infusion

Sponsors & Collaborators

  • Grupo Espanol de Investigacion en Sarcomas

    lead OTHER

Principal Investigators

  • Andrés Redondo · Hospital Universitario La Paz

  • Claudia Valverde · Hospital Universitari Vall d'Hebrón

  • Katarina Majercakova · Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

  • Josefina Cruz · Hospital Universitario de Canarias

  • Rosa Álvarez · Hospital General Universitario Gregorio Marañón

  • Antonio Casado · Hospital San Carlos, Madrid

  • Javier Martín Broto · Hospital Universitario Fundación Jiménez Díaz

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
16 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-28
Primary Completion
2024-07-28
Completion
2024-07-28

Countries

  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05131386 on ClinicalTrials.gov