Radiation Therapy in Treating Patients With Cervical Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00278304
Recruitment Status : Completed
First Posted : January 18, 2006
Last Update Posted : June 20, 2013
Information provided by:
National Cancer Institute (NCI)

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.

Condition or disease Intervention/treatment Phase
Cervical Cancer Radiation: brachytherapy Radiation: radiation therapy Phase 2

Detailed Description:



  • 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.


  • 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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Primary Purpose: Treatment
Official Title: A Pilot Study of MR-Guided High Dose Rate Brachytherapy With MR Image Acquisition for Patients With Cervical Cancer
Study Start Date : September 2005
Actual Study Completion Date : June 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cervical Cancer

Primary Outcome Measures :
  1. Feasibility
  2. Comparison of dose-volume estimations based on 3D imaging-based treatment planning, with the traditional point dose method based on orthogonal radiographs

Secondary Outcome Measures :
  1. Tolerance
  2. Toxicity
  3. Correlate three-dimensional dose-volume histograms of organs at risk with treatment toxicity
  4. Disease status
  5. Time and patterns of relapse
  6. Survival distributions

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No


  • 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


  • 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


  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00278304

United States, Maryland
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
Bethesda, Maryland, United States, 20892-1182
Sponsors and Collaborators
National Cancer Institute (NCI)
Principal Investigator: Shervin Karimpour, MD NCI - Radiation Oncology Branch; ROB Identifier: NCT00278304     History of Changes
Obsolete Identifiers: NCT00214396
Other Study ID Numbers: CDR0000454997
First Posted: January 18, 2006    Key Record Dates
Last Update Posted: June 20, 2013
Last Verified: April 2006

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
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female