NCT00278304CompletedPhase 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 enrollmentStarted: September 1, 2005Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Feasibility
Study 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.
Study Design
- Study Type
- Interventional
- Primary Purpose
- Treatment
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
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
- Survival distributions
- Correlate three-dimensional dose-volume histograms of organs at risk with treatment toxicity
- Toxicity
- Disease status
- Time and patterns of relapse
Investigators
Study Sites (1)
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