Radiation Therapy in Treating Patients With Cervical Cancer

National Cancer Institute (NCI)20 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Purpose

TREATMENT

Enrollment

Conditions

Cervical Cancer

Interventions

brachytherapyRADIATION

radiation therapyRADIATION

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support

Bethesda, Maryland, United States

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

Toxicity

Correlate three-dimensional dose-volume histograms of organs at risk with treatment toxicity

Disease status

Time and patterns of relapse

Survival distributions

Data from ClinicalTrials.gov

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