Spots Global Cancer Trial Database for Gemcitabine and Docetaxel With Radiation in Adults With Soft Tissue Sarcoma of the Extremities

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Trial Identification

Brief Title: Gemcitabine and Docetaxel With Radiation in Adults With Soft Tissue Sarcoma of the Extremities

Official Title: Phase I Trial Study of Gemcitabine and Docetaxel With Radiation in Adult Patients With High Grade and Greater Than 5 cm Soft Tissue Sarcoma of the Extremities

Study ID: NCT04037527

Conditions

Soft Tissue Sarcoma

Interventions

Study Description

Brief Summary: The purpose of this Phase 1 research study is to obtain data or information on the safety and effectiveness of the combination of gemcitabine, docetaxel with radiation.

Detailed Description: Primary Objective: • To determine the maximum tolerated doses Gemcitabine and Taxotere when given weekly with concurrent radiation in the neoadjuvant setting for patients with soft tissue sarcoma of the extremities. Secondary Objective: • To evaluate immunological changes induced by gemcitabine and docetaxel with radiation in patient with high risk-soft tissue sarcomas in blood. This would include T cell subsets, NK, and dendritic cells and tumor macrophages all of which make up the tumor microenvironment. Long term follow-up will occur every 3-4 months for 24 months in person or video consultation.