NCT00356031

Bevacizumab and Radiation Therapy for Sarcomas

A Phase II Study of Neoadjuvant Bevacizumab and Radiation Therapy for Resectable Soft Tissue Sarcomas

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

* 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.

Conditions

• Soft Tissue Sarcoma
• Fibrous Histiocytoma
• Liposarcoma
• Leiomyosarcoma
• Fibrosarcoma
• Synovial Sarcoma

Interventions

Type	Name	Description
DRUG	Bevacizumab	Bevacizumab 5mg/kg given intravenously every 2 weeks for a total of 4 doses
RADIATION	Radiation Therapy	External beam radiation given two weeks after the first bevacizumab infusion and delivered 5 days a week at 1.8 Gy per day, over 6 weeks. Total radiation dose is 50.4 Gy. For patients with tumors in the retroperitoneum or pelvis, intraoperative radiation therapy (10-20 Gy) may be given for close or positive margins at the discretion of the radiation oncologist and surgeon. For patients with tumors in the extremity or trunk, post-operative external beam radiation therapy (10-20 Gy) will be given for close or positive margins assuming wound healing is good.
PROCEDURE	Surgery	Surgical resection is performed 6-7 weeks after completion of neoadjuvant therapy.

Timeline

• Start date: 2006-07-01
• Primary completion: 2010-03-01
• Completion: 2010-03-01
• First posted: 2006-07-25
• Last updated: 2017-05-19
• Results posted: 2017-05-19

Locations

1 site across 1 country: United States