| ID | Type | Description | Link |
|---|---|---|---|
| NCI-05-C-0233 |
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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.
OBJECTIVES:
Primary
Secondary
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| brachytherapy | Radiation | |||
| radiation therapy | Radiation |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Tolerance | ||
| Toxicity | ||
| Correlate three-dimensional dose-volume histograms of organs at risk with treatment toxicity |
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DISEASE CHARACTERISTICS:
Histologically confirmed carcinoma of the cervix of 1 of the following cellular subtypes:
Stages IB-IVA disease
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:
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
No prior definitive surgical oncologic procedures (e.g., radical hysterectomy)
Concurrent chemotherapy, immunotherapy, or hormonal therapy allowed
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| Name | Affiliation | Role |
|---|---|---|
| Shervin Karimpour, MD | NCI - Radiation Oncology Branch; ROB | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support | Bethesda | Maryland | 20892-1182 | United States |
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| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D001918 | Brachytherapy |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| Disease status |
| Time and patterns of relapse |
| Survival distributions |
| D009369 |
| Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |