Phase II Study of 5-Day Hypofractionated Preoperative Radiation Therapy for Soft Tissue Sarcomas: Expansion Cohort

Jonsson Comprehensive Cancer Center

Status: Enrolling

Conditions: Recurrent Adult Soft Tissue Sarcoma

Treatments: Radiation: Hypofractionated Radiation Therapy; Other: Laboratory Biomarker Analysis; Other: Questionnaire Administration; Procedure: Conventional Surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT02701153

NCI-2016-00202 (Registry Identifier)

15-001657 (Other Identifier)

Details and patient eligibility

About

This phase II trial studies the side effects of hypofractionated radiation therapy in treating patients with soft tissue sarcomas prior to surgery. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells and have fewer side effects.

Full description

PRIMARY OBJCETIVES:

I. Grade >= 2 radiation morbidity (subcutaneous tissue fibrosis, joint stiffness, or edema) at 2 years.

SECONDARY OBJECTIVES:

I. Evaluate local control, regional control, distant metastasis, progression free survival, and overall survival.

II. Evaluate the functional outcomes as assessed using the musculoskeletal tumor rating scale (MSTS) and the Toronto Extremity Salvage Score (TESS).

III. Collect germ-line deoxyribonucleic acid (DNA) and nucleic acids from cancer patients to further investigate the association and identify new germ-line mutations that impact cancer predisposition.

IV. Investigate the role of germ-line mutations in predicting cancer outcome and response to therapy.

OUTLINE:

Patients undergo hypofractionated radiation therapy on Monday-Friday for 5 days. Beginning 2-12 weeks after completion of radiation therapy, patients undergo surgery.

After completion of study treatment, patients are followed up at 3 months and then every 6 months for 5 years.

Enrollment: 51 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histologically confirmed soft tissue sarcoma of the extremity/trunk
• Intermediate or high grade sarcoma
• Resectable primary lesion (patients with pre-existing metastasis will be included if their primary is still going to be resected)
• Recurrent, any grade, no previous radiation therapy
• Karnofsky performance status (KPS) >= 70 or Eastern Cooperative Oncology Group (ECOG) 0 - 2
• If a woman is of childbearing potential, a negative serum pregnancy test must be documented

Exclusion criteria

• Active treatment of a separate malignancy
• History of prior irradiation to the area to be treated
• Pre-operative chemotherapy (post-op acceptable)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

51 participants in 1 patient group

Treatment (hypofractionated radiation therapy)

Experimental group

Description:

Patients undergo hypofractionated radiation therapy on Monday-Friday for 5 days. Beginning 2-12 weeks after completion of radiation therapy, patients undergo surgery.

Treatment:

Other: Questionnaire Administration

Procedure: Conventional Surgery

Other: Laboratory Biomarker Analysis

Radiation: Hypofractionated Radiation Therapy