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

Study Overview
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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

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

Conditions
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Cancer Recurrence, Solid Tumors

Intervention / Treatment
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* Procedure: PET/CT
* Procedure: NCCN recommendations for solid tumor post treatment


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: PET/CT follow-up<br>PET/CT with history and physical exams at 3,9,18,36,60 months only | Procedure: PET/CT<br>* 5 visits with PET/CT as only testing<br>|
| Other: conventional follow-up<br>NCCN recommendations | Procedure: NCCN recommendations for solid tumor post treatment<br>* 12-14 visits with exams, blood tests, CTs and PET/CT<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ThatPET/CT will be superior (15% improvement) to conventional methods of follow-up in terms of 5 year survival, cost and time to identification of new disease |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in patient/caregiver compliance in keeping their appointments and completing their tests |  | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cancer, colorectal, head/neck, lung, PET/CT