Hypofractionated Pre-operative Radiation Therapy for Soft Tissue Sarcomas of the Extremity and Chest-wall

Completed · Not applicable

Conditions studied: Soft Tissue Sarcoma

In brief

This is a nonrandomized Phase II pilot protocol to determine the feasibility, toxicity and disease control (local control, overall and progression-free survival) using hypofractionated preoperative radiation therapy in patients with primary localized soft tissue sarcomas (STS).

Key facts

Study ID: NCT02634710
Run by: Medical College of Wisconsin
People needed: 35
Starts: 2016-02-23
Expected to finish: 2022-06-14
Last updated by the study team: 2025-12-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

≥ 18 years of age
Core needle biopsy obtained
Pathologic confirmation of primary soft tissue sarcoma of the upper or lower extremity or chest-wall.
Stage I-III Soft Tissue Sarcoma of the extremity without evidence of metastatic disease
Medically operable
No prior radiotherapy to primary site or adjacent site that results in overlapping radiation fields.
MRI obtained of the affected extremity or chest-wall
CT chest acquired to assess distant disease
Karnofsky Performance Status (KPS) 60 or above
Informed consent obtained prior to study entry

You may not qualify if…

Patients who have metastatic disease
Pregnant women
Women of childbearing potential and male participants must practice adequate contraception.
Disease pathology other than sarcoma subtypes
Patients with a history of metastatic disease from a primary other than sarcoma
Patients who cannot undergo MRI as part of pre-treatment or treatment planning process
STS of non-extremity or chest-wall regions
Tumor size ≥ 20 cm maximal dimension

Where it is running

Froedtert Hospital — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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