Summary

for people ages 18 years and up (full criteria)
at UCLA
study started
estimated completion
Mitchell Kamrava(ucla)

Description

Summary

This phase II trial studies the side effects of hypofractionated radiation therapy in treating patients with soft tissue sarcomas that have come back before 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.

Official Title

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

Details

PRIMARY OBJCETIVES:

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

SECONDARY OBJECTIVES:

  1. 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.

Keywords

Recurrent Adult Soft Tissue Sarcoma Sarcoma Hypofractionated Radiation Therapy Laboratory Biomarker Analysis

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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

You CAN'T join if...

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

Location

  • UCLA / Jonsson Comprehensive Cancer Center accepting new patients
    Los Angeles California 90095 United States

Lead Scientist

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Jonsson Comprehensive Cancer Center
ID
NCT02701153
Study Type
Interventional
Last Updated