Hypofractionated Radiation Therapy in Treating Patients with Unresectable or Metastatic Soft Tissue Sarcoma

Status: closed to accrual

This phase II trial studies how well hypofractionated radiation therapy works in treating patients with soft tissue sarcoma that cannot be removed by surgery (unresectable) or has spread to other places in the body (metastatic). Hypofractionated radiation therapy is a cancer treatment that delivers intense doses of radiation to cancer cells over fewer treatments to help minimize damage to healthy tissue. Hypofractionated radiotherapy involves the use of sophisticated image guidance that pinpoints the exact three-dimensional location of a tumor so that the radiation can be more precisely delivered to cancer cells. This study examines how well hypofractionated radiotherapy controls soft tissue sarcomas and the side effects from using hypofractionated radiotherapy to treat these tumors.

Inclusion Criteria

Biopsy proven soft tissue sarcoma, either localized and inoperable/unresectable or metastatic, that is deemed by the treating physician to be targetable with hypofractionated radiotherapy
Patient refuses surgery or is aware that surgery is not recommended for them
Karnofsky performance status >= 60
Able to understand and sign an informed consent form
ADDITIONAL OPTIONAL SPECIMEN COLLECTION STUDY
All patients enrolled in this trial are all also eligible for a specimen collection study (Health Sciences Institutional Review Board [HS IRB] approved study 2017-0394) where blood samples and archived tissue if available are collected at the completion of this trial
Should patients opt to enroll specimen collection study their blood would be accessible to study various biomarkers under protocol 2017-0394

Exclusion Criteria

Pregnant
Chemotherapy or systemic anti-cancer treatment within the preceding two weeks
Unable to undergo imaging or positioning necessary for radiotherapy planning
Prior radiation therapy in the field that, at the discretion of the treating physician, prevents safe delivery of hypofractionated radiotherapy

PRIMARY OBJECTIVE:

I. Assess 2-year local control of soft tissue sarcomas following hypofractionated radiotherapy and compare the rates to historical series of fractionated radiation treatments.

SECONDARY OBJECTIVES:

I. Assess short- term toxicity in patients with soft tissue sarcomas who are treated with hypofractionated radiation therapy.

II. Assess long-term toxicity in patients with soft tissue sarcomas who are treated with hypofractionated radiotherapy and compare these rates to historical fractioned series.

III. Assess rates of complete response of soft tissue sarcomas following hypofractionated radiotherapy.

IV. Assess 5-year local control of soft tissue sarcomas following hypofractionated radiotherapy.

V. Evaluate progression-free and overall survival in patients with soft tissue sarcoma following hypofractionated radiotherapy.

OUTLINE:

Patients undergo 3-8 fractions of hypofractionated radiation therapy over 30-60 minutes each for up to 8 weeks in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 1 and 2-3 months, every 3-6 for 2 years, every 6 months for 2 years, and then annually for 1 year.

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Hypofractionated Radiation Therapy in Treating Patients with Unresectable or Metastatic Soft Tissue Sarcoma

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