Radiation Therapy in Treating Patients With Cervical Cancer

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: Cervical Cancer
• Intervention / Treatment: Radiation: radiation therapy; Radiation: brachytherapy

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

Study Locations

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

Participation Criteria

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

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

• Sponsor: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Shervin Karimpour, MD, NCI - Radiation Oncology Branch; ROB

Study record dates

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: cervical squamous cell carcinoma; stage IIB cervical cancer; stage III cervical cancer; stage IVA cervical cancer; stage IB cervical cancer; stage IIA cervical cancer; stage IVB cervical cancer; cervical adenocarcinoma; cervical adenosquamous cell carcinoma
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Uterine Neoplasms; Genital Neoplasms, Female; Uterine Cervical Diseases; Uterine Diseases; Uterine Cervical Neoplasms
• Other Study ID Numbers: CDR0000454997; NCI-05-C-0233