Bevacizumab and Radiation Therapy for Sarcomas
Recruitment status was Recruiting
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.
Soft Tissue Sarcoma
Procedure: Radiation Therapy
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study of Neoadjuvant Bevacizumab and Radiation Therapy for Resectable Soft Tissue Sarcomas|
- To determine the objective response rate for neoadjuvant bevacizumab combined with radiation therapy for intermediate and high-risk soft tissue sarcomas. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- To analyze the biologic effects of this regimen on tumor vasculature, blood flow, and oxygenation [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- to obtain preliminary data regarding local control, distant control, disease-free survival, and overall survival with this regimen. [ Time Frame: TBD ] [ Designated as safety issue: No ]
|Study Start Date:||July 2006|
|Estimated Study Completion Date:||March 2010|
|Estimated Primary Completion Date:||March 2010 (Final data collection date for primary outcome measure)|
- 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.
|Contact: Yen-Lin Chen, MDfirstname.lastname@example.org|
|United States, Massachusetts|
|Massachusetts General Hospital||Recruiting|
|Boston, Massachusetts, United States, 02114|
|Principal Investigator:||Yen-Lin Chen, MD||Massachusetts General Hospital|