Intensity Modulated Radiotherapy (IMRT) for the Pelvis Post-Hysterectomy

September 11, 2017 updated by: M.D. Anderson Cancer Center

Pilot Study of Intensity Modulated Radiotherapy (IMRT) to Pelvis Post-Hysterectomy With Analysis of Clinical Target Volume Motion and Relation to Position and Volume of Bladder and Rectum During Course of Radiotherapy for Use in Optimization of Margin Size

The goal of this clinical research study is to use CT scans to find any changes in position of the vagina and pelvic lymph node areas during the course of IMRT radiation therapy. Treatment can then be adjusted in order to "spare" as much normal tissue as possible during radiation therapy. Another goal is to study the side effects of IMRT radiation therapy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The standard radiotherapy technique for delivering radiation therapy to the pelvis following a hysterectomy involves a technique which also causes a large amount of normal tissue to receive radiation. This can cause both early and late side effects, which may be severe. The new technique of intensity modulated radiotherapy (IMRT) has been used to help spare normal tissue, especially tissue of the small bowel. This is an advanced new technology that delivers the high-dose of radiation to the target area but avoids the normal tissue. Using CT scans, the target is outlined by the doctors before treatment. However, sometimes organs in the pelvis move throughout the course of treatment. Using CT scans during treatment and re-outlining the target may help to deliver more radiation to the cancer tissues and less to the surrounding normal areas.

During the study, you will have additional CT scans that will be performed on a special scanner in the radiation treatment room. You also will have additional CT scans twice a week during the 5 weeks of radiation treatment. The first 12 participants enrolled will receive the standard radiation therapy taking into account the maximum possible movements of the bladder. No adjustments will be made according to the results of the additional CT scans. The next 12 participants may have their radiation therapy adjusted according to the CT scans in an effort to target less of the normal tissue without missing cancer tissue. To reduce movement of your bladder due to different amounts of fluid in your bladder, you will be asked to drink 3 glasses of water before treatment and to come for treatment with a full bladder.

The volumes of your bladder and rectum will also be studied, and any side effects of the treatment will be recorded. You will be asked to fill out a short questionnaire about the side effects of your treatment 3 times per week during treatment. It should take around 5 minutes to complete the questionnaire.

Patients will be followed for at least 2 years. (Every 3 months for 1 year and 4 months for second year according to usual clinic practice.)

This is an investigational study. IMRT radiation therapy is an approved method of treating some types of cancer. However, adjusting the radiation treatment according to the movement of the internal organs is investigational. Initial CT scans for treatment planning are part of standard treatment. Up to 24 participants will take part in this study. All will be enrolled at M. D. Anderson.

Study Type

Observational

Enrollment (Actual)

24

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • University of Texas MD Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Women treated with a hysterectomy for carcinoma of the uterine cervix or endometrium who require post-operative radiation or chemoradiation therapy because of positive pelvic lymph nodes or other high-risk local findings.

Description

Inclusion Criteria:

  1. Patients who have been treated with a hysterectomy for carcinoma of the uterine cervix or endometrium who require post-operative radiation or chemoradiation therapy because of positive pelvic lymph nodes or other high-risk local findings.
  2. Patients must have no evidence of metastatic disease outside of the pelvis.
  3. Patients must have a Karnofsky Performance Status of >60.
  4. The patient must be able to understand the protocol and sign a study-specific informed consent. .

Exclusion Criteria:

  1. Karnofsky Performance Status < 60.
  2. Patients with para-aortic nodal disease or who require extended field radiotherapy beyond the pelvis.
  3. Obese patients who exceed the size limits of hte treatment table or CT scanner.
  4. Mental status changes or bladder control problems that make the patient unable to comply with bladder-filling instructions.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
CT Scan + IMRT Radiation Therapy
Radiation: Intensity Modulated Radiotherapy (IMRT)
Dose of 45Gy
Procedure: CT Scan
CT Scans: Twice a week during the 5 weeks of radiation treatment.
Other Names:
  • Computed Tomography

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Maximum variations in position of the vagina and lymph node regions caused by bladder filling and emptying
Time Frame: 2 Years (every 3 months for first year and 4 months for second year)
2 Years (every 3 months for first year and 4 months for second year)

Secondary Outcome Measures

Outcome Measure
Time Frame
Day-to-day variations in position of vaginal vault and pelvic lymph node regions
Time Frame: During a 5-week course of intensity modulated pelvic radiation therapy
During a 5-week course of intensity modulated pelvic radiation therapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M.D. Anderson Cancer Center

Investigators

  • Principal Investigator: Patricia J. Eifel, MD, M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 5, 2003

Primary Completion (ACTUAL)

September 8, 2017

Study Completion (ACTUAL)

September 8, 2017

Study Registration Dates

First Submitted

July 26, 2007

First Submitted That Met QC Criteria

July 26, 2007

First Posted (ESTIMATE)

July 30, 2007

Study Record Updates

Last Update Posted (ACTUAL)

September 12, 2017

Last Update Submitted That Met QC Criteria

September 11, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ID03-0047

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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