Radiation Therapy in Treating Patients With Cervical Cancer

June 18, 2013 updated by: National Cancer Institute (NCI)

A Pilot Study of MR-Guided High Dose Rate Brachytherapy With MR Image Acquisition for Patients With Cervical Cancer

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Bethesda, Maryland, United States, 20892-1182
        • Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Feasibility
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

Outcome Measure
Toxicity
Disease status
Tolerance
Correlate three-dimensional dose-volume histograms of organs at risk with treatment toxicity
Time and patterns of relapse
Survival distributions

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Shervin Karimpour, MD, NCI - Radiation Oncology Branch; ROB

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2005

Study Completion (Actual)

June 1, 2006

Study Registration Dates

First Submitted

January 16, 2006

First Submitted That Met QC Criteria

January 16, 2006

First Posted (Estimate)

January 18, 2006

Study Record Updates

Last Update Posted (Estimate)

June 20, 2013

Last Update Submitted That Met QC Criteria

June 18, 2013

Last Verified

April 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000454997
  • NCI-05-C-0233

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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