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OpenTrials
Completed

NCT Number: NCT00278304

Radiation Therapy in Treating 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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support

Bethesda, Maryland, 20892-1182, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Brachytherapy

Radiation

radiation therapy

Radiation

Primary outcomes

  1. Feasibility

  2. Comparison of dose-volume estimations based on 3D imaging-based treatment planning, with the traditional point dose method based on orthogonal radiographs

Secondary outcomes

  1. Tolerance

  2. Toxicity

  3. Correlate three-dimensional dose-volume histograms of organs at risk with treatment toxicity

  4. Disease status

  5. Time and patterns of relapse

  6. Survival distributions

Sponsors and collaborators

Lead sponsor

National Cancer Institute (NCI)

Nih

Registry information

Official study title

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

Important dates

Study start
2005
Study completion
2006
First posted
Jan 18, 2006
Registry last updated
Jun 20, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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