Back to resultsDefining the Utility of PET/CT in the Follow-up of Patients With Solid Tumors
Primary Purpose
Cancer Recurrence, Solid Tumors
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PET/CT
NCCN recommendations for solid tumor post treatment
Sponsored by
About this trial
This is an interventional diagnostic trial for Cancer Recurrence focused on measuring cancer, colorectal, head/neck, lung, PET/CT
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
Sites / Locations
- VA North Texas Health Care System
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Other
Arm Label
PET/CT follow-up
conventional follow-up
Arm Description
PET/CT with history and physical exams at 3,9,18,36,60 months only
NCCN recommendations
Outcomes
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
Secondary Outcome Measures
Improvement in patient/caregiver compliance in keeping their appointments and completing their tests
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00954148
Brief Title
Defining the Utility of PET/CT in the Follow-up of Patients With Solid Tumors
Official Title
Defining the Utility of PET/CT in the Follow-up of Patients With Solid Tumors
Study Type
Interventional
2. Study Status
Record Verification Date
May 2010
Overall Recruitment Status
Terminated
Why Stopped
1st years Enrollment #s showed study was not going to meet criteria randomization.
Study Start Date
September 2009 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
June 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Dallas VA Medical Center
4. Oversight
Data Monitoring Committee
No
5. 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).
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer Recurrence, Solid Tumors
Keywords
cancer, colorectal, head/neck, lung, PET/CT
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
53 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PET/CT follow-up
Arm Type
Active Comparator
Arm Description
PET/CT with history and physical exams at 3,9,18,36,60 months only
Arm Title
conventional follow-up
Arm Type
Other
Arm Description
NCCN recommendations
Intervention Type
Procedure
Intervention Name(s)
PET/CT
Intervention Description
5 visits with PET/CT as only testing
Intervention Type
Procedure
Intervention Name(s)
NCCN recommendations for solid tumor post treatment
Intervention Description
12-14 visits with exams, blood tests, CTs and PET/CT
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
Improvement in patient/caregiver compliance in keeping their appointments and completing their tests
Time Frame
5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James LePage, PH.D
Organizational Affiliation
ACOS for Research VA North TX Health Care System
Official's Role
Study Chair
Facility Information:
Facility Name
VA North Texas Health Care System
City
Dallas
State/Province
Texas
ZIP/Postal Code
75216
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Defining the Utility of PET/CT in the Follow-up of Patients With Solid Tumors
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