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Phase II Study of Patient Positioning Using Multiple CT Scans in Patients With Prostate Cancer Undergoing External Beam Radiotherapy

Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

CT Scans in Guiding the Treatment of Patients With Prostate Cancer Who are Undergoing Radiation Therapy

Basic Trial Information

Phase
Type
Status
Age
Sponsor
Protocol IDs

Phase II

Diagnostic, Treatment

Completed

Not specified

NCI

MSKCC-01022
NCI-G01-1968, NCT00020891

Objectives

Compare the accuracy of radiotherapy delivery using multiple CT scans to guide patient positioning vs the standard portal image guided procedure in patients with prostate cancer undergoing external beam radiotherapy.
Determine the reduction in the proportion of patients with large target positioning errors using the CT-guided procedure.
Determine organ motion and setup errors over the course of radiotherapy in order to develop efficient clinical intervention strategies in these patients.

Entry Criteria

Disease Characteristics:

Undergoing external beam intensity-modulated radiotherapy for prostate cancer

Able to maintain treatment position for about 40 minutes

Prior/Concurrent Therapy:

Biologic therapy:

Not specified

Chemotherapy:

Not specified

Endocrine therapy:

Not specified

Radiotherapy:

See Disease Characteristics

Surgery:

Not specified

Patient Characteristics:

Age:

Not specified

Performance status:

Not specified

Life expectancy:

Not specified

Hematopoietic:

Not specified

Hepatic:

Not specified

Renal:

Not specified

Expected Enrollment

A total of 25 patients will be accrued for this study within 2 years.

Outcomes

Primary Outcome(s)

Treatment accuracy

Secondary Outcome(s)

Reduction in the proportion of patients with large target positioning errors using CT guided procedure
Organ motion and setup errors

Outline

Patients undergo radiotherapy over 9 weeks. Patients undergo a CT scan immediately prior to receiving radiotherapy on treatment days 3-8 and then weekly thereafter. On 3 different days, patients also undergo CT scan immediately after radiotherapy. If the CT scans indicate a correction that exceeds the action level currently in effect, then beginning with the next treatment, the patient's position with respect to the radiation field is adjusted.

Trial Contact Information

Trial Lead Organizations

Memorial Sloan-Kettering Cancer Center

Michael Lovelock, PhD, Protocol chair
Ph: 212-639-6032; 800-525-2225

Registry Information

Official Title		The Use Of Multiple CT Scans To Reduce Target Positioning Errors In Patients Undergoing External Beam Radiotherapy Treatment For Prostate Cancer

Trial Start Date		2001-03-13

Registered in ClinicalTrials.gov		NCT00020891

Date Submitted to PDQ		2001-05-07

Information Last Verified		2006-08-15

NCI Grant/Contract Number		CA08748

Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.