MDACC Study Summary ID03-0047

Study Summary
No. ID03-0047:.......Gynecology......Patricia J. Eifel......Radiation Oncology

Study Summary Title



Study Summary Number:	ID03-0047

Study Title:	A pilot study of intensity modulated radiotherapy (IMRT) to the pelvis post-hysterectomy with analysis of the clinical target volume motion and its relation to position and volume of the bladder and rectum during the course of radiotherapy for use in optimization of margin size.

Physician

New Patient Referral



Name:	Patricia J. Eifel	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Radiation Oncology	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-563-6930 Contact us about clinical trials

General Information



Disease Group:	Gynecology	Supported By:	N/A

Phase of Study:	Phase I/Phase II	Return Visit:	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.)

Treatment Agents:	Radiation	Home Care:	N/A

Treatment Loc:	Only at MDACC

Estimated Length of Stay in Houston:	outpatient treatment - no anticipated hospitalization


Description/ Intervention:	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 Objectives / Outcomes

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

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.

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.

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.

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

Study Status Information



Study Activation / Registration Date:	03/05/2003

IRB Review and Approval Date:	02/19/2003

Study Type:	Diagnostic

Recruitment Status:	Closed

Projected Accrual:	24

Enrollment Eligibility

If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

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.

Links

Registration Number: NCT00508703
Study Information on Clinical Trials Registry (clinicaltrials.gov)