RecruitingNot ApplicableNCT02701153
Phase II Study of 5-Day Hypofractionated Preoperative Radiation Therapy for Soft Tissue Sarcomas: Expansion Cohort
Sponsor
Jonsson Comprehensive Cancer Center
Enrollment
51 participants
Start Date
Feb 3, 2016
Study Type
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Min Age: 18 Years
Inclusion Criteria6
- 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 Criteria3
- Active treatment of a separate malignancy
- History of prior irradiation to the area to be treated
- Pre-operative chemotherapy (post-op acceptable)
Interventions
PROCEDUREConventional Surgery
Undergo surgery
RADIATIONHypofractionated Radiation Therapy
Undergo hypofractionated radiation therapy
OTHERLaboratory Biomarker Analysis
Correlative studies
OTHERQuestionnaire Administration
Ancillary studies
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT02701153