Cervical Cancer
Conditions
Keywords
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
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.
Interventions
RADIATIONbrachytherapy
RADIATIONradiation therapy
Sponsors
National Cancer Institute (NCI)
Study design
Primary purpose
TREATMENT
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | 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
| Measure | Time frame |
|---|---|
| Correlate three-dimensional dose-volume histograms of organs at risk with treatment toxicity | — |
| Disease status | — |
| Tolerance | — |
| Survival distributions | — |
| Time and patterns of relapse | — |
| Toxicity | — |
Countries
United States
Outcome results
None listed