Ignite Creation Date:
2024-05-05 @ 4:36 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00278304
Status:
COMPLETED
Last Update Posted:
2013-06-20
First Post:
2006-01-16
Brief Title:
Radiation Therapy in Treating Patients With Cervical Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Pilot Study of MR-Guided High Dose Rate Brachytherapy With MR Image Acquisition for Patients With Cervical Cancer
Status:
COMPLETED
Status Verified Date:
2006-04
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:
RATIONALE Radiation therapy uses high-energy x-rays to kill tumor cells Internal radiation uses radioactive material placed directly into or near a tumor to kill tumor cells Giving radiation therapy in different ways may kill more tumor cells
PURPOSE This phase II trial is studying how well giving external-beam radiation together with internal radiation works in treating patients with cervical cancer
PURPOSE This phase II trial is studying how well giving external-beam radiation together with internal radiation works in treating patients with cervical cancer
Detailed Description:
OBJECTIVES
Primary
Determine the feasibility of magnetic resonance-guided endocavitary high-dose rate brachytherapy implants in patients with stage IB-IVB cervical cancer
Provide more reliable dose-volume estimations based on three-dimensional imaging-based treatment planning in patients treated with this regimen
Secondary
Determine the toxic effects and treatment tolerance in patients treated with this regimen
Correlate three-dimensional dose-volume histograms of organs at risk with treatment toxicity in patients treated with this regimen
Determine the disease status time and patterns of relapse and survival of patients treated with this regimen
OUTLINE Patients undergo external beam radiotherapy 4-5 days a week for up to 7 weeks Patients also undergo MRI-guided high-dose brachytherapy comprising one brachytherapy implant a week for 3-6 implants Brachytherapy may be administered during or after external beam radiotherapy
After completion of study treatment patients are followed periodically for 5 years
PROJECTED ACCRUAL A total of 20 patients will be accrued for this study
Primary
Determine the feasibility of magnetic resonance-guided endocavitary high-dose rate brachytherapy implants in patients with stage IB-IVB cervical cancer
Provide more reliable dose-volume estimations based on three-dimensional imaging-based treatment planning in patients treated with this regimen
Secondary
Determine the toxic effects and treatment tolerance in patients treated with this regimen
Correlate three-dimensional dose-volume histograms of organs at risk with treatment toxicity in patients treated with this regimen
Determine the disease status time and patterns of relapse and survival of patients treated with this regimen
OUTLINE Patients undergo external beam radiotherapy 4-5 days a week for up to 7 weeks Patients also undergo MRI-guided high-dose brachytherapy comprising one brachytherapy implant a week for 3-6 implants Brachytherapy may be administered during or after external beam radiotherapy
After completion of study treatment patients are followed periodically for 5 years
PROJECTED ACCRUAL A total of 20 patients will be accrued for this study
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-05-C-0233 | None | None | None |