Ignite Creation Date:
2024-05-05 @ 5:01 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00369122
Status:
COMPLETED
Last Update Posted:
2018-03-20
First Post:
2006-08-24
Brief Title:
Bevacizumab Radiation Therapy and Cisplatin in Treating Patients With Previously Untreated Locally Advanced Cervical Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A PHASE II STUDY OF BEVACIZUMAB IN COMBINATION WITH DEFINITIVE RADIOTHERAPY AND CISPLATIN CHEMOTHERAPY IN UNTREATED PATIENTS WITH LOCALLY ADVANCED CERVICAL CARCINOMA
Status:
COMPLETED
Status Verified Date:
2018-02
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:
This phase II trial is studying how well giving bevacizumab together with radiation therapy and cisplatin works in treating patients with previously untreated locally advanced cervical cancer Monoclonal antibodies such as bevacizumab can block tumor growth in different ways Some block the ability of tumor cells to grow and spread Others find tumor cells and help kill them or carry tumor-killing substances to them Bevacizumab may also stop the growth of cervical cancer by blocking blood flow to the tumor Radiation therapy uses high-energy x-rays to kill tumor cells Drugs used in chemotherapy such as cisplatin work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Giving bevacizumab together with radiation therapy and cisplatin may kill more tumor cells
Detailed Description:
PRIMARY OBJECTIVES
I Determine treatment-related serious adverse-event rates and adverse-event rates within the first 90 days from treatment start in patients with previously untreated locally advanced carcinoma of the cervix treated with bevacizumab cisplatin and concurrent pelvic radiotherapy
SECONDARY OBJECTIVES
I Evaluate treatment-related serious adverse events and adverse events at any time
II Evaluate disease-free survival local regional or distant failure or death due to any cause
III Evaluate overall survival death due to any cause IV Implement the image-based brachytherapy guidelines proposed by the Transatlantic Image-Guided Brachytherapy Working Group
V Collect CT scan or MRI-based dosimetry of brachytherapy applications used during the course of treatment for later analysis of feasibility and consistency as well as dosevolume assessments of tumor control and complications
OUTLINE This is a multicenter study
Patients undergo pelvic external-beam radiotherapy EBRT once daily 5 days a week for 5 weeks for a total of 45 Gy
Some patients also undergo low-dose rate brachytherapy twice 1-3 weeks apart beginning 4 weeks after initiating EBRT or high-dose rate brachytherapy 5 times 48 hours apart beginning 2 weeks after initiating EBRT EBRT and chemotherapy are halted on the day of high-dose rate brachytherapy Patients receive bevacizumab IV over 30-90 minutes on days 1 15 and 29 and cisplatin IV over 60 minutes on days 1 8 15 22 29 and 35
After completion of study treatment patients are followed periodically
I Determine treatment-related serious adverse-event rates and adverse-event rates within the first 90 days from treatment start in patients with previously untreated locally advanced carcinoma of the cervix treated with bevacizumab cisplatin and concurrent pelvic radiotherapy
SECONDARY OBJECTIVES
I Evaluate treatment-related serious adverse events and adverse events at any time
II Evaluate disease-free survival local regional or distant failure or death due to any cause
III Evaluate overall survival death due to any cause IV Implement the image-based brachytherapy guidelines proposed by the Transatlantic Image-Guided Brachytherapy Working Group
V Collect CT scan or MRI-based dosimetry of brachytherapy applications used during the course of treatment for later analysis of feasibility and consistency as well as dosevolume assessments of tumor control and complications
OUTLINE This is a multicenter study
Patients undergo pelvic external-beam radiotherapy EBRT once daily 5 days a week for 5 weeks for a total of 45 Gy
Some patients also undergo low-dose rate brachytherapy twice 1-3 weeks apart beginning 4 weeks after initiating EBRT or high-dose rate brachytherapy 5 times 48 hours apart beginning 2 weeks after initiating EBRT EBRT and chemotherapy are halted on the day of high-dose rate brachytherapy Patients receive bevacizumab IV over 30-90 minutes on days 1 15 and 29 and cisplatin IV over 60 minutes on days 1 8 15 22 29 and 35
After completion of study treatment patients are followed periodically
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 |
|---|---|---|---|
| U10CA021661 | NIH | CTEP | httpsreporternihgovquickSearchU10CA021661 |
| NCI-2009-00722 | REGISTRY | None | None |
| CDR0000493005 | None | None | None |
| RTOG 0417 | OTHER | None | None |
| RTOG-0417 | OTHER | None | None |