Radiation Therapy in Treating Patients With Cervical Cancer
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|ClinicalTrials.gov Identifier: NCT00278304|
Recruitment Status : Completed
First Posted : January 18, 2006
Last Update Posted : June 20, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Cervical Cancer||Radiation: brachytherapy Radiation: radiation therapy||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Official Title:||A Pilot Study of MR-Guided High Dose Rate Brachytherapy With MR Image Acquisition for Patients With Cervical Cancer|
|Study Start Date :||September 2005|
|Actual Study Completion Date :||June 2006|
- Comparison of dose-volume estimations based on 3D imaging-based treatment planning, with the traditional point dose method based on orthogonal radiographs
- Correlate three-dimensional dose-volume histograms of organs at risk with treatment toxicity
- Disease status
- Time and patterns of relapse
- Survival distributions
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|