Cancer Recurrence, Solid Tumors
Conditions
Keywords
cancer, colorectal, head/neck, lung, PET/CT
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
Interventions
PROCEDUREPET/CT
5 visits with PET/CT as only testing
PROCEDURENCCN recommendations for solid tumor post treatment
12-14 visits with exams, blood tests, CTs and PET/CT
Sponsors
Dallas VA Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | Time frame |
|---|---|
| Improvement in patient/caregiver compliance in keeping their appointments and completing their tests | 5 years |
Countries
United States
Outcome results
None listed