Status:
COMPLETED
Radiation Therapy in Treating Patients With Cervical Cancer
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Cervical Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
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 therap...
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 reliab...
Eligibility Criteria
Inclusion
- 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
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2006
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00278304
Start Date
September 1 2005
End Date
June 1 2006
Last Update
June 20 2013
Active Locations (1)
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1
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
Bethesda, Maryland, United States, 20892-1182