Radiation Therapy in Treating Patients With Cervical Cancer

NCT ID: NCT00278304

Last Updated: 2013-06-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-09-30
• Study Completion Date: 2006-06-30

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.

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.

Conditions

Cervical Cancer

Study Design

• Primary Study Purpose: TREATMENT

Interventions

brachytherapy

Intervention Type: RADIATION

radiation therapy

Intervention Type: RADIATION

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: lead

Principal Investigators

Shervin Karimpour, MD

Role: PRINCIPAL_INVESTIGATOR

NCI - Radiation Oncology Branch; ROB

Locations

Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support

Bethesda, Maryland, United States

Countries

United States

Other Identifiers

NCI-05-C-0233

Identifier Type: -

Identifier Source: secondary_id

CDR0000454997

Identifier Type: -

Identifier Source: org_study_id

NCT00214396

Identifier Type: -

Identifier Source: nct_alias