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Clinical Trials/NCT00954148
NCT00954148
Terminated
Not Applicable

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

Dallas VA Medical Center1 site in 1 country53 target enrollmentSeptember 2009

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cancer Recurrence
Sponsor
Dallas VA Medical Center
Enrollment
53
Locations
1
Primary Endpoint
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
Status
Terminated
Last Updated
15 years ago

Overview

Brief Summary

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

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

Registry
clinicaltrials.gov
Start Date
September 2009
End Date
June 2010
Last Updated
15 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

Time Frame: 5 years

Secondary Outcomes

  • Improvement in patient/caregiver compliance in keeping their appointments and completing their tests(5 years)

Study Sites (1)

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