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

Conditions

• Recurrent Adult Soft Tissue Sarcoma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Conventional Surgery — PROCEDURE
  Undergo surgery
• Hypofractionated Radiation Therapy — RADIATION
  Undergo hypofractionated radiation therapy
• Laboratory Biomarker Analysis — OTHER
  Correlative studies
• Questionnaire Administration — OTHER
  Ancillary studies

Study Details

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.

Key Dates

Start date

Feb 3, 2016

Status verified

Mar 2026

Primary completion

Feb 3, 2027

Completion

Feb 3, 2028

Study Design

Enrollment

51 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Treatment (hypofractionated radiation therapy)
  Patients undergo hypofractionated radiation therapy on Monday-Friday for 5 days. Beginning 2-12 weeks after completion of radiation therapy, patients undergo surgery.

Primary Outcome Measure

Grade >= 2 radiation morbidity (subcutaneous tissue fibrosis, joint stiffness, or edema) [ Time Frame: Up to 2 years ]

Central Contacts

• Jackie Hernandez
  310-206-8477
  [email protected]

Locations (1)

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