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

Sponsor

Dallas VA Medical Center (U.S. Fed)

Overall Status

Terminated

CT.gov ID

NCT00954148

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

5.9

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Cancer Recurrence Solid Tumors	Procedure: PET/CT Procedure: NCCN recommendations for solid tumor post treatment	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

53 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Diagnostic

Official Title:

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

Study Start Date :

Sep 1, 2009

Actual Primary Completion Date :

May 1, 2010

Actual Study Completion Date :

Jun 1, 2010

Arms and Interventions

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

Arm

Intervention/Treatment

Active Comparator: PET/CT follow-up

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

Procedure: PET/CT

5 visits with PET/CT as only testing

Other: conventional follow-up

NCCN recommendations

Procedure: NCCN recommendations for solid tumor post treatment

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

Outcome Measures

Primary Outcome Measures

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

Improvement in patient/caregiver compliance in keeping their appointments and completing their tests [5 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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