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Clinical Trials/NCT00278304
NCT00278304
Completed
Phase 2

A Pilot Study of MR-Guided High Dose Rate Brachytherapy With MR Image Acquisition for Patients With Cervical Cancer

National Cancer Institute (NCI)1 site in 1 country20 target enrollmentSeptember 2005
ConditionsCervical Cancer

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Cervical Cancer
Sponsor
National Cancer Institute (NCI)
Enrollment
20
Locations
1
Primary Endpoint
Feasibility
Status
Completed
Last Updated
12 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 2005
End Date
June 2006
Last Updated
12 years ago
Study Type
Interventional
Sex
Female

Investigators

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Feasibility

Comparison of dose-volume estimations based on 3D imaging-based treatment planning, with the traditional point dose method based on orthogonal radiographs

Secondary Outcomes

  • Tolerance
  • Correlate three-dimensional dose-volume histograms of organs at risk with treatment toxicity
  • Toxicity
  • Disease status
  • Time and patterns of relapse
  • Survival distributions

Study Sites (1)

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