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

Not Applicable

Terminated

• Conditions: Cancer Recurrence; Solid Tumors
• Interventions: Procedure: PET/CT; Procedure: NCCN recommendations for solid tumor post treatment

• Registration Number: NCT00954148
• Lead Sponsor: Dallas VA Medical Center

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

Study Timeline

• Study First Submitted: 2009-08-05
• Study First Submitted QC: 2009-08-06
• Study First Posted: 2009-08-07
• Study Start: 2009-09
• Status Verified: 2010-05
• Primary Completion: 2010-05
• Study Completion: 2010-06
• Last Update Submitted: 2010-06-29
• Last Update Posted: 2010-06-30

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 53

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PET/CT follow-up	PET/CT	PET/CT with history and physical exams at 3,9,18,36,60 months only
conventional follow-up	NCCN recommendations for solid tumor post treatment	NCCN recommendations

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Improvement in patient/caregiver compliance in keeping their appointments and completing their tests	5 years

Trial Locations

Locations (1)

VA North Texas Health Care System; 🇺🇸 Dallas, Texas, United States