Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
96

Summary

Conditions
  • Leiomyosarcoma
  • Liposarcoma
  • Liposarcoma, Myxoid
  • Pleomorphic Liposarcoma
  • Sarcoma, Soft Tissue
Type
Interventional
Phase
Phase 1Phase 2
Design
Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Description

In this study investigators plan to measure tumor response (RECIST and Choi criteria) when administering trabectedin standard dose or inferior with simultaneous radiotherapy treatment. The hypothesis states that administering trabectedin at 1.3mg/m2 or ?1.5mg/m2 plus Radiotherapy 30-45Gy shows syner...

In this study investigators plan to measure tumor response (RECIST and Choi criteria) when administering trabectedin standard dose or inferior with simultaneous radiotherapy treatment. The hypothesis states that administering trabectedin at 1.3mg/m2 or ?1.5mg/m2 plus Radiotherapy 30-45Gy shows synergic activity that turns into tumor shrinkage. A phase I trial (dose escalation -or de-escalation for cohort C- level of 1.3 or 1.5 mg/m2) will provide the proper dose level to perform a phase II trial to measure RECIST and Choi response, progression free survival, overall survival and register safety and quality of life details. Three cohorts are indicated for this trial, A: Patients with diagnosis of non-operable or unresectable or not oncologically recommended metastasectomy of limited to lung metastases soft tissue sarcoma and cohort B: Patients with locally advanced resectable Myxoid Liposarcoma, C:Patients with retroperitoneal and resectable soft tissue sarcoma (liposarcoma and leiomyosarcoma). Unlimited cycles of chemotherapy are considered to be beneficial for cohort A patients, whereas cohort B and C only 3 cycles are indicated. About radiotherapy treatment, 30Gy will be given to cohort A patients, whereas cohort B and C will receive 45Gy. TCs and MRI are selected for imaging purposes. Phase I: For cohorts A and B:Trabectedin at two dose escalation levels: 0 1.3 mg/m2 as a 24h I.V. infusion 1 1.5 mg/m2 as a 24h I.V. infusion For cohort C:Trabectedin at two dose de-escalation levels: 0 1.5 mg/m2 as a 24h I.V. infusion -1 1.3 mg/m2 as a 24h I.V. infusion Administration of trabectedin with a portable pump, i.v infusion of 24h, in cycles of 3 weeks. Premedication: 4 mg oral dexamethasone 24h and 12h before chemotherapy administration. 20 mg I.V. dexamethasone 30minutes before treatment. Ondansetron or analogue will also be given prior to trabectedin. Pathology review, radiology review and radiotherapy review are performed to every patient. Several biomarkers are selected to perform FFPE tumor assays in relation to prediction

Tracking Information

NCT #
NCT02275286
Collaborators
  • Centre Leon Berard
  • Italian Sarcoma Group
Investigators
Principal Investigator: Javier Martín-Broto, MD Hospital Virgen del Rocío