Radiation Therapy in Treating Patients With Cervical Cancer
This study has been completed.
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00278304
First received: January 16, 2006
Last updated: February 6, 2009
Last verified: April 2006
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Cervical Cancer |
Radiation: brachytherapy Radiation: radiation therapy |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | A Pilot Study of MR-Guided High Dose Rate Brachytherapy With MR Image Acquisition for Patients With Cervical Cancer |
Resource links provided by NLM:
Further study details as provided by National Cancer Institute (NCI):
Primary Outcome Measures:
- Feasibility [ Designated as safety issue: No ]
- Comparison of dose-volume estimations based on 3D imaging-based treatment planning, with the traditional point dose method based on orthogonal radiographs [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Tolerance [ Designated as safety issue: Yes ]
- Toxicity [ Designated as safety issue: Yes ]
- Correlate three-dimensional dose-volume histograms of organs at risk with treatment toxicity [ Designated as safety issue: Yes ]
- Disease status [ Designated as safety issue: No ]
- Time and patterns of relapse [ Designated as safety issue: No ]
- Survival distributions [ Designated as safety issue: No ]
| Estimated Enrollment: | 20 |
| Study Start Date: | September 2005 |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00278304
Locations
| United States, Maryland | |
| Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support | |
| Bethesda, Maryland, United States, 20892-1182 | |
Sponsors and Collaborators
Investigators
| Principal Investigator: | Shervin Karimpour, MD | NCI - Radiation Oncology Branch; ROB |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00278304 History of Changes |
| Obsolete Identifiers: | NCT00214396 |
| Other Study ID Numbers: | CDR0000454997, NCI-05-C-0233 |
| Study First Received: | January 16, 2006 |
| Last Updated: | February 6, 2009 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
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 |
Additional relevant MeSH terms:
|
Uterine Cervical Neoplasms Uterine Neoplasms Genital Neoplasms, Female Urogenital Neoplasms Neoplasms by Site |
Neoplasms Uterine Cervical Diseases Uterine Diseases Genital Diseases, Female |
ClinicalTrials.gov processed this record on May 21, 2013