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: June 18, 2013
Last verified: April 2006
  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
Study Completion Date: June 2006
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.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: June 18, 2013
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 August 27, 2014