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Radiation Therapy in Treating Patients With Cervical Cancer

Primary Purpose

Cervical Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
brachytherapy
radiation therapy
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cervical Cancer focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Tolerance
Toxicity
Correlate three-dimensional dose-volume histograms of organs at risk with treatment toxicity
Disease status
Time and patterns of relapse
Survival distributions

Full Information

First Posted
January 16, 2006
Last Updated
June 18, 2013
Sponsor
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00278304
Brief Title
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

2. Study Status

Record Verification Date
April 2006
Overall Recruitment Status
Completed
Study Start Date
September 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Radiation
Intervention Name(s)
brachytherapy
Intervention Type
Radiation
Intervention Name(s)
radiation therapy
Primary Outcome Measure Information:
Title
Feasibility
Title
Comparison of dose-volume estimations based on 3D imaging-based treatment planning, with the traditional point dose method based on orthogonal radiographs
Secondary Outcome Measure Information:
Title
Tolerance
Title
Toxicity
Title
Correlate three-dimensional dose-volume histograms of organs at risk with treatment toxicity
Title
Disease status
Title
Time and patterns of relapse
Title
Survival distributions

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shervin Karimpour, MD
Organizational Affiliation
NCI - Radiation Oncology Branch; ROB
Official's Role
Principal Investigator
Facility Information:
Facility Name
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892-1182
Country
United States

12. IPD Sharing Statement

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Radiation Therapy in Treating Patients With Cervical Cancer

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