Trial Information
A Phase II Study of Preoperative Intensity-Modulated Radiation Therapy For Lower Limb Soft Tissue Sarcoma
Inclusion Criteria:
- Histologically proven soft tissue sarcoma
- Lesion lies between the iliac crest (hipbone) and the ankle
- Lesion is newly diagnosed
- Assessed by radiation oncologist and surgical oncologist
Exclusion Criteria:
- Benign histologies
- Histologies generally treated with chemotherapy
- Prior or recurrent cancer, except nonmelanomatous skin cancer or carcinoma in-situ
of the cervix
Type of Study:
Interventional
Study Design:
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Outcome Measure:
Major wound complications within 120 days following surgery
Outcome Time Frame:
120 days post-op
Safety Issue:
No
Principal Investigator
Brian O'Sullivan, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Princess Margaret Hospital, Canada
Authority:
Canada: Ethics Review Committee
Study ID:
UHN REB 03-0107-C
NCT ID:
NCT00188175
Start Date:
May 2003
Completion Date:
May 2014
Related Keywords: