Ignite Creation Date:
2024-05-05 @ 4:58 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00356031
Status:
COMPLETED
Last Update Posted:
2017-05-19
First Post:
2006-07-21
Brief Title:
Bevacizumab and Radiation Therapy for Sarcomas
Sponsor:
Massachusetts General Hospital
Organization:
Massachusetts General Hospital
Study Overview
Official Title:
A Phase II Study of Neoadjuvant Bevacizumab and Radiation Therapy for Resectable Soft Tissue Sarcomas
Status:
COMPLETED
Status Verified Date:
2017-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1R21CA117128-01A1 | NIH | None | httpsreporternihgovquickSearch1R21CA117128-01A1 |