Study Stopped
1st years Enrollment #s showed study was not going to meet criteria randomization.
Defining the Utility of PET/CT in the Follow-up of Patients With Solid Tumors
1 other identifier
interventional
53
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2009
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 5, 2009
CompletedFirst Posted
Study publicly available on registry
August 7, 2009
CompletedStudy Start
First participant enrolled
September 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2010
CompletedJune 30, 2010
May 1, 2010
8 months
August 5, 2009
June 29, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Improvement in patient/caregiver compliance in keeping their appointments and completing their tests
5 years
Study Arms (2)
PET/CT follow-up
ACTIVE COMPARATORPET/CT with history and physical exams at 3,9,18,36,60 months only
conventional follow-up
OTHERNCCN recommendations
Interventions
12-14 visits with exams, blood tests, CTs and PET/CT
Eligibility Criteria
You may qualify if:
- Completed primary therapy such that no disease is evident at the time of enrollment in the study
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
VA North Texas Health Care System
Dallas, Texas, 75216, United States
MeSH Terms
Conditions
Study Officials
- STUDY CHAIR
James LePage, PH.D
ACOS for Research VA North TX Health Care System
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
Study Record Dates
First Submitted
August 5, 2009
First Posted
August 7, 2009
Study Start
September 1, 2009
Primary Completion
May 1, 2010
Study Completion
June 1, 2010
Last Updated
June 30, 2010
Record last verified: 2010-05