Clinical trial NCT00278304: Radiation Therapy in Treating Patients With Cervical Cancer
Official title: A Pilot Study of MR-Guided High Dose Rate Brachytherapy With MR Image Acquisition for Patients With Cervical Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cervical Cancer
Keywords: 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
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2006-01-18
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Feasibility
measure: Comparison of dose-volume estimations based on 3D imaging-based treatment planning, with the traditional point dose method based on orthogonal radiographs
Secondary outcomes:
measure: Tolerance
measure: Toxicity
measure: Correlate three-dimensional dose-volume histograms of organs at risk with treatment toxicity
measure: Disease status
measure: Time and patterns of relapse
measure: Survival distributions
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
state: Maryland
Study officials:
affiliation: NCI - Radiation Oncology Branch; ROB
name: Shervin Karimpour, MD
role: PRINCIPAL_INVESTIGATOR
References: