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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


Phase 1/Phase 2
N/A
N/A
Open (Enrolling)
Female
Uterine Cancer, Cervical Cancer, Endometrial Cancer

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Trial Information

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 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.


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.

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

Maximum variations in position of the vagina and lymph node regions caused by bladder filling and emptying

Outcome Time Frame:

2 Years (every 3 months for first year and 4 months for second year)

Safety Issue:

No

Principal Investigator

Patricia J. Eifel, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

ID03-0047

NCT ID:

NCT00508703

Start Date:

March 2003

Completion Date:

Related Keywords:

  • Uterine Cancer
  • Cervical Cancer
  • Endometrial Cancer
  • Uterine Cancer
  • Cervical Cancer
  • Endometrial Cancer
  • Intensity Modulated Radiotherapy
  • IMRT
  • Computed Tomography
  • CT
  • CT Scan
  • Endometrial Neoplasms
  • Uterine Cervical Neoplasms
  • Uterine Neoplasms
  • Adenoma

Name

Location

U.T.M.D. Anderson Cancer CenterHouston, Texas  77030