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Clinical Trial 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.


Clinical Trial 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. ;


Study Design

Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00278304
Study type Interventional
Source National Cancer Institute (NCI)
Contact
Status Completed
Phase Phase 2
Start date September 2005
Completion date June 2006

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