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.