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

GEIS0 sites96 target enrollmentOctober 3, 2014

Overview

No summary available.

Registry

who.int

Start Date

October 3, 2014

End Date

TBD

Last Updated

11 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

GEIS

•Inclusion Criteria Cohort A
•\-Aged between 18 and 70\.
•\-Patients must have a diagnostic of Soft Tissue Sarcoma with metastasis limited to lung, and not suitable for metatasectomy or surgery resection or not oncologically recommended metastasectomy
•\-Patients must have documentation of disease progression within 6 months prior to study entry.
•\-The patient must have been considered eligible for systemic chemotherapy. A maximum of two previous lines for advanced/metastatic disease are allowed as long as trabectedin has not been included.
•\-The following histological subtypes can be included:
•\+Undifferentiated pleomorphic sarcoma (previously, malignant fibrous histiocytoma)
•\+Leiomyosarcoma
•\+Angiosarcoma/ epithelial hemangioendothelioma
•\+Liposarcoma and its variants (well differentiated, dedifferentiated, myxoid/round cells, pleomorphic)

•\-Previous treatment with trabectedin or radiotherapy involving any lung field.
•\-Performance status ? 2 (ECOG).
•\-Metastases out of those located in lungs.
•\-Plasma bilirubin \> UNL.
•\-Creatinine \> 1\.6 mg/dL.
•\-History of other neoplastic disease with the exception of basal cell carcinoma or in situ cervical cancer adequately treated.
•\-Severe COPD or other severe pulmonary diseases.
•\-Significant cardiovascular disease (for example, dyspnea \> 2 NYHA)
•\-Significant systemic diseases grade 3 or higher on the NCI\-CTCAE v4\.03 scale, that limit patient availability, or according to investigator judgment may contribute significantly to treatment toxicity.
•\-Uncontrolled bacterial, mycotic or viral infections.