Soft Tissue Sarcoma Clinical Trial
Official title:
A Phase II Study of Neoadjuvant Bevacizumab and Radiation Therapy for Resectable Soft Tissue Sarcomas
The main purpose of this study is to test the effectiveness of bevacizumab in combination with radiation therapy to see what effects (good or bad) they have on patients with soft tissue sarcoma. Bevacizumab is an antibody designed specifically to slow or stop the growth of cancerous tumors by decreasing the blood supply to the tumor. Bevacizumab is approved by the FDA in combination with intravenous 5-fluorouracil-based chemotherapy as a treatment for patients with cancer of the colon or rectum that has spread. However, the use of bevacizumab in combination with radiation for sarcomas is still under investigation.
- The dose of bevacizumab and radiation therapy will be the same for all participants
throughout the study.
- Bevacizumab will be given as an intravenous infusion every 2 weeks for a total of 4
doses.
- Radiation therapy will begin 2 weeks after the first bevacizumab infusion and will be
delivered 5 days per week over a period of 6 weeks. This is done as an outpatient
procedure. Each 2 week period will be considered a separate treatment cycle.
Participants will be treated with radiation therapy for a maximum of 3 cycles (6
weeks).
- A surgeon will evaluate the participants tumor by radiologic studies before study
treatment to determine if surgical removal is possible. After the completion of study
treatment, a surgeon will repeat the evaluation of the tumor. Surgery will performed
6-7 weeks after the completion of radiation therapy.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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