Hypofractionated Radiation Therapy in Treating Patients With Recurrent Soft Tissue Sarcomas Before Surgery



Status:Recruiting
Conditions:Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:3/1/2019
Start Date:February 3, 2016
End Date:February 3, 2021

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Phase II Study of Hypofractionated Radiation Therapy for Soft Tissue Sarcomas

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.

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.

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)
We found this trial at
1
site
Los Angeles, California 90095
Principal Investigator: Mitchell R. Kamrava
Phone: 310-825-9771
?
mi
from
Los Angeles, CA
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