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


Phase 2
18 Years
N/A
Not Enrolling
Female
Cervical Cancer

Thank you

Trial Information

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


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.

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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Outcome Measure:

Feasibility

Safety Issue:

No

Principal Investigator

Shervin Karimpour, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

NCI - Radiation Oncology Branch; ROB

Authority:

United States: Federal Government

Study ID:

CDR0000454997

NCT ID:

NCT00278304

Start Date:

September 2005

Completion Date:

June 2006

Related Keywords:

  • Cervical Cancer
  • 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
  • Uterine Cervical Neoplasms

Name

Location

Warren Grant Magnuson Clinical Center - NCI Clinical Studies SupportBethesda, Maryland  20892-1182