Radiation Therapy in Treating Patients With Cervical Cancer
- Conditions
- Cervical Cancer
- Registration Number
- NCT00278304
- Lead Sponsor
- National Cancer Institute (NCI)
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 20
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Feasibility Comparison of dose-volume estimations based on 3D imaging-based treatment planning, with the traditional point dose method based on orthogonal radiographs
- Secondary Outcome Measures
Name Time Method Tolerance Correlate three-dimensional dose-volume histograms of organs at risk with treatment toxicity Toxicity Disease status Time and patterns of relapse Survival distributions
Trial Locations
- Locations (1)
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
🇺🇸Bethesda, Maryland, United States