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Defining the Utility of PET/CT in the Follow-up of Patients With Solid Tumors

NCT ID: NCT00954148

Last Updated: 2010-06-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

53 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2010-06-30

Brief Summary

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This is a comparison, at this VA Hospital,of routine multi-visit and multi-testing for solid tumor recurrence in four tumor groups to a limited scheduled 5 visit history/physical with PET/CT only, over a five year period. The purpose is to show through utilization of the single most sensitive and specific test currently available-PET/CT-that survival for patients in follow-up can be improved.(Plus lowering medical costs and increasing patient confidence and compliance with follow-up appointments).

Detailed Description

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Routine visits would include COLON:14 visits with cea and 6 CTs over a 5 year period plus PET/CT at last visit RECTAL: 14 visits with cea and 6 CTs and 4 procto exams over 5 year period plus PET/CT at last visit HEAD/NECK: 14 visits with 4 CTs and PET/CT at last visit LUNG:12 visits plus 4 CTs and PET/CT at last visit

Limited follow-up ALL GROUPS: a history and physical plus PET/CT at 3 month, 9 month, 18 month, 36 month and 60 month only

Conditions

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Cancer Recurrence Solid Tumors

Keywords

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cancer colorectal head/neck lung PET/CT

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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PET/CT follow-up

PET/CT with history and physical exams at 3,9,18,36,60 months only

Group Type ACTIVE_COMPARATOR

PET/CT

Intervention Type PROCEDURE

5 visits with PET/CT as only testing

conventional follow-up

NCCN recommendations

Group Type OTHER

NCCN recommendations for solid tumor post treatment

Intervention Type PROCEDURE

12-14 visits with exams, blood tests, CTs and PET/CT

Interventions

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PET/CT

5 visits with PET/CT as only testing

Intervention Type PROCEDURE

NCCN recommendations for solid tumor post treatment

12-14 visits with exams, blood tests, CTs and PET/CT

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Completed primary therapy such that no disease is evident at the time of enrollment in the study

Exclusion Criteria

* Patients unable to consent
* Without diagnosis of colorectal cancer
* Non-small cell lung cancer or squamous cell cancer of the head and neck
* Unwilling or unable to participate in the assigned follow-up program
* Having a serum glucose at time of PET/CT greater than 180mg/dl
* Stage IV disease or with evidence of disease recurrence post treatment
* Who are not a candidate for further treatment should a recurrence of disease be identified
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dallas VA Medical Center

FED

Sponsor Role lead

Responsible Party

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VANTXHCS Dallas, TX

Principal Investigators

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James LePage, PH.D

Role: STUDY_CHAIR

ACOS for Research VA North TX Health Care System

Locations

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VA North Texas Health Care System

Dallas, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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09-017

Identifier Type: -

Identifier Source: org_study_id