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Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II, Phase I	Treatment	Active	Not specified	Other	ID03-0047 NCT00508703

Trial Description

Summary

1. To evaluate maximum variations in position of the vagina and lymph node regions caused by bladder filling and emptying.

2. To accurately measure day-to-day variations in the position of the vaginal vault and pelvic lymph node regions during a 5-week course of intensity modulated pelvic radiation therapy.

3. To evaluate the reproducibility of bladder filling throughout a five-week course of pelvic intensity modulated radiotherapy in patients who have been instructed to use a specified schedule of fluid intake; this will permit up to more accurately define the minimum margins that could safely be used with intensity modulated radiotherapy to the pelvis after hysterectomy.

4. To measure the effect of variations in bladder and rectal volume on the doses that would be delivered to tumor, bladder, rectum, and small bowel using theoretical treatment plans with reduced margins.

5. To evaluate the nature and prevalence of acute and late toxicity and their relation to the volume of tissue irradiated with IMRT.

Further Study Information

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 UTMDACC.

Eligibility 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 the treatment table or CT scanner.

4. Mental status changes or bladder control problems that make the patient unable to comply with bladder-filling instructions.

Trial Contact Information

Trial Lead Organizations/Sponsors

M. D. Anderson Cancer Center at University of Texas

Patricia J. Eifel

Principal Investigator

Patricia J. Eifel, MD

Ph: 713-792-3440

U.S.A.
Texas
	Houston
	M. D. Anderson Cancer Center at University of Texas
		Patricia J. Eifel	Principal Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00508703
Information obtained from ClinicalTrials.gov on March 18, 2009