Radiation Therapy in Treating Patients With Cervical Cancer

National Cancer Institute (NCI)

Status and phase: Completed; Phase 2

Conditions: Cervical Cancer

Treatments: Radiation: radiation therapy; Radiation: brachytherapy

Study type: Interventional

Funder types: NIH

Identifiers

NCT00278304

NCI-05-C-0233

CDR0000454997

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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