Radiation Therapy in Treating Patients With Cervical Cancer

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Cervical Cancer

Intervention / Treatment
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* Radiation: brachytherapy
* Radiation: radiation therapy


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically confirmed carcinoma of the cervix of 1 of the following cellular subtypes: Squamous cell Adenocarcinoma Adenosquamous cell Stages IB-IVA disease Stage IVB disease allowed provided the impact on the quality of life is tremendous (e.g., frozen pelvis or massive pelvic disease and fistula formation, severe pain, or bleeding) Measurable and/or evaluable disease on MRI PATIENT CHARACTERISTICS: ECOG performance status 0-2 No physical or physiological capacity that would preclude study treatment No cognitively impaired patients who cannot provide informed consent Not pregnant or nursing Negative pregnancy test No contraindication to MRI, including any of the following: Weight > 136 kg Allergy to MR contrast agent Pacemakers, cerebral aneurysm clips, shrapnel injury, or implantable electronic devices No significant unrelated systemic illness No serious infections No significant cardiac, pulmonary, hepatic, or other organ dysfunction that would preclude study treatment Must be medically fit to receive anesthesia PRIOR CONCURRENT THERAPY: No prior definitive brachytherapy procedures Ring implants or intravaginal cones for the relief of excessive bleeding allowed No prior definitive surgical oncologic procedures (e.g., radical hysterectomy) Concurrent chemotherapy, immunotherapy, or hormonal therapy allowed

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Radiation: brachytherapy|nan|
|Radiation: radiation therapy|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cervical adenocarcinoma, cervical adenosquamous cell carcinoma, cervical squamous cell carcinoma, stage IB cervical cancer, stage IIA cervical cancer, stage IIB cervical cancer, stage III cervical cancer, stage IVA cervical cancer, stage IVB cervical cancer