Radiation Therapy in Treating Patients With Cervical Cancer
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.
Radiation: radiation therapy
|Study Design:||Primary Purpose: Treatment|
|Official Title:||A Pilot Study of MR-Guided High Dose Rate Brachytherapy With MR Image Acquisition for Patients With Cervical Cancer|
- Feasibility [ Designated as safety issue: No ]
- Comparison of dose-volume estimations based on 3D imaging-based treatment planning, with the traditional point dose method based on orthogonal radiographs [ Designated as safety issue: No ]
- Tolerance [ Designated as safety issue: Yes ]
- Toxicity [ Designated as safety issue: Yes ]
- Correlate three-dimensional dose-volume histograms of organs at risk with treatment toxicity [ Designated as safety issue: Yes ]
- Disease status [ Designated as safety issue: No ]
- Time and patterns of relapse [ Designated as safety issue: No ]
- Survival distributions [ Designated as safety issue: No ]
|Study Start Date:||September 2005|
|Study Completion Date:||June 2006|
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00278304
|United States, Maryland|
|Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support|
|Bethesda, Maryland, United States, 20892-1182|
|Principal Investigator:||Shervin Karimpour, MD||NCI - Radiation Oncology Branch; ROB|