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

This study has been completed.

Sponsor:

Collaborator:

National Cancer Institute (NCI)

Information provided by:

Memorial Sloan-Kettering Cancer Center

ClinicalTrials.gov Identifier:

NCT00020891

First received: July 11, 2001

Last updated: January 17, 2013

Last verified: January 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

July 11, 2001

Last Updated Date

January 17, 2013

Start Date ^ICMJE

March 2001

Primary Completion Date

June 2006 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Treatment accuracy [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00020891 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Reduction in the proportion of patients with large target positioning errors using CT guided procedure [ Designated as safety issue: No ]
Organ motion and setup errors [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Multiple CT scans may improve the accuracy of radiation therapy for prostate cancer.

PURPOSE: Phase I trial to study the effectiveness of multiple CT scans in guiding the treatment of patients who have prostate cancer and are undergoing radiation therapy.

Detailed Description

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.

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.

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

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Primary Purpose: Diagnostic

Condition ^ICMJE

Prostate Cancer

Intervention ^ICMJE

Procedure: computed tomography
Radiation: radiation therapy

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

Completion Date

Not Provided

Primary Completion Date

June 2006 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

DISEASE CHARACTERISTICS:

Undergoing external beam intensity-modulated radiotherapy for prostate cancer
Able to maintain treatment position for about 40 minutes

PATIENT CHARACTERISTICS:

Age:

Not specified

Performance status:

Not specified

Life expectancy:

Not specified

Hematopoietic:

Not specified

Hepatic:

Not specified

Renal:

Not specified

PRIOR CONCURRENT THERAPY:

Biologic therapy:

Not specified

Chemotherapy:

Not specified

Endocrine therapy:

Not specified

Radiotherapy:

See Disease Characteristics

Surgery:

Not specified

Gender

Male

Ages

Not Provided

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00020891

Other Study ID Numbers ^ICMJE

01-022, P30CA008748, MSKCC-01022, NCI-G01-1968

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Memorial Sloan-Kettering Cancer Center

Collaborators ^ICMJE

National Cancer Institute (NCI)

Investigators ^ICMJE

Study Chair:

Michael Lovelock, PhD

Memorial Sloan-Kettering Cancer Center

Information Provided By

Memorial Sloan-Kettering Cancer Center

Verification Date

January 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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