A Phase II Study of Neoadjuvant Bevacizumab and Radiation Therapy for Resectable Soft Tissue Sarcomas
- 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.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine the objective response rate for neoadjuvant bevacizumab combined with radiation therapy for intermediate and high-risk soft tissue sarcomas.
3 years
No
Yen-Lin Chen, MD
Principal Investigator
Massachusetts General Hospital
United States: Food and Drug Administration
05-090
NCT00356031
July 2006
March 2010
Name | Location |
---|---|
Massachusetts General Hospital | Boston, Massachusetts 02114-2617 |