Radiation Therapy in Treating Patients With Cervical Cancer - Full Text View

Sponsored by:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00278304

Purpose

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.

Condition	Intervention	Phase
Cervical Cancer	Radiation: brachytherapy Radiation: radiation therapy	Phase II

MedlinePlus related topics: Cancer Radiation Therapy X-Rays

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment
Official Title:	A Pilot Study of MR-Guided High Dose Rate Brachytherapy With MR Image Acquisition for Patients With Cervical Cancer

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Feasibility [ Designated as safety issue: No ]
Comparison of dose-volume estimations based on 3D imaging-based treatment planning, with the traditional point dose method based on orthogonal radiographs [ Designated as safety issue: No ]

Secondary Outcome Measures:

Tolerance [ Designated as safety issue: Yes ]
Toxicity [ Designated as safety issue: Yes ]
Correlate three-dimensional dose-volume histograms of organs at risk with treatment toxicity [ Designated as safety issue: Yes ]
Disease status [ Designated as safety issue: No ]
Time and patterns of relapse [ Designated as safety issue: No ]
Survival distributions [ Designated as safety issue: No ]

Estimated Enrollment:	20
Study Start Date:	September 2005

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00278304

Locations

United States, Maryland
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
Bethesda, Maryland, United States, 20892-1182

Sponsors and Collaborators

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Shervin Karimpour, MD

NCI - Radiation Oncology Branch; ROB

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000454997, NCI-05-C-0233
Study First Received:	January 16, 2006
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00278304 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

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

Study placed in the following topic categories:

Epidermoid Carcinoma
Squamous Cell Carcinoma
Adenocarcinoma

Carcinoma, Squamous Cell
Carcinoma, Adenosquamous
Carcinoma

ClinicalTrials.gov processed this record on May 07, 2009