Clinical Trial: Phase I-II Trial, Multicenter, Open, Exploring Trabectedin Plus Radiotherapy in Soft Tissue Sarcoma Patients

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

Brief Summary:

Phase I-II trial that combines trabectedin plus radiotherapy for tumor reduction response measure in two 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. Phase I: escalating dose of 1.3 or 1.5 mg/m2. Radiotherapy for cohort A: 30Gy in 10 fractions (3Gy/fraction) Radiotherapy for cohort B: 45Gy in 25 fractions (1.8Gy/fraction) A translational substudy is developed to analyse different biomarkers predictive value.


Detailed Summary:

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 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.

To 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. Unlimited cycles of chemotherapy are considered to be beneficial for cohort A patients, whereas cohort B only 3 cycles are indicated. About radiotherapy treatment, 30Gy will be given to cohort A patients, whereas cohort B will receive 45Gy. TCs and MRI are selected for imaging purposes.

Several biomarkers are selected to perform FFPE tumor assays in relation to prediction


Sponsor: Grupo Espanol de Investigacion en Sarcomas

Current Primary Outcome: Tumor size [ Time Frame: every 6 weeks for 24 months ]

Image tumor assessment measured by RECIST criteria.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Number and type of adverse events [ Time Frame: every 21 days until 30 days after last dose or during 25 months ]
    CTCAE v4.03 adverse events registration to evaluate safety
  • Number of months without progression [ Time Frame: 24 months ]
    Progression free survival (PFS)
  • Number of months alive [ Time Frame: 24 months ]
    Overall survival (OS)
  • Tumor size [ Time Frame: every 6 weeks during 24 months ]
    Image tumor assessment measured by Choi criteria.
  • Questionnaire [ Time Frame: every 3 months during 24 months ]
    QLQ-C30 EORTC questionnaire to evaluate patient quality of life


Original Secondary Outcome: Same as current

Information By: Grupo Espanol de Investigacion en Sarcomas

Dates:
Date Received: October 17, 2014
Date Started: November 2014
Date Completion: June 2018
Last Updated: February 22, 2017
Last Verified: February 2017