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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00508703
First received: July 26, 2007
Last updated: September 29, 2014
Last verified: September 2014
  Purpose

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.


Condition Intervention Phase
Uterine Cancer
Cervical Cancer
Endometrial Cancer
Radiation: Intensity Modulated Radiotherapy (IMRT)
Procedure: CT Scan
Phase 1
Phase 2

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: 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

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 24
Study Start Date: March 2003
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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 Name: Computed Tomography

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.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00508703

Locations
United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Patricia J. Eifel, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00508703     History of Changes
Other Study ID Numbers: ID03-0047
Study First Received: July 26, 2007
Last Updated: September 29, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Uterine Cancer
Cervical Cancer
Endometrial Cancer
Intensity Modulated Radiotherapy
IMRT
Computed Tomography
CT
CT Scan

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Diseases, Female
Genital Neoplasms, Female
Neoplasms
Neoplasms by Site
Urogenital Neoplasms
Uterine Cervical Diseases
Uterine Diseases

ClinicalTrials.gov processed this record on November 25, 2014