Ignite Creation Date:
2025-12-24 @ 9:15 PM
Ignite Modification Date:
2025-12-25 @ 7:04 PM
Study NCT ID:
NCT00278304
Status:
COMPLETED
Last Update Posted:
2013-06-20
First Post:
2006-01-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Radiation Therapy in Treating Patients With Cervical Cancer
Sponsor:
National Cancer Institute (NCI)
Organization:
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 ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-05-C-0233 | None | None | View |