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

This study has been terminated.
(1st years Enrollment #s showed study was not going to meet criteria randomization.)
Sponsor:
Information provided by:
Dallas VA Medical Center
ClinicalTrials.gov Identifier:
NCT00954148
First received: August 5, 2009
Last updated: June 29, 2010
Last verified: May 2010
History of Changes
  Purpose

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 Intervention
Cancer Recurrence
Solid Tumors
 Procedure: PET/CT
Procedure: NCCN recommendations for solid tumor post treatment

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Defining the Utility of PET/CT in the Follow-up of Patients With Solid Tumors

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by Dallas VA Medical Center:

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 [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Improvement in patient/caregiver compliance in keeping their appointments and completing their tests [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Enrollment: 53
Study Start Date: September 2009
Study Completion Date: June 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
conventional follow-up
NCCN recommendations
 Procedure: NCCN recommendations for solid tumor post treatment
12-14 visits with exams, blood tests, CTs and PET/CT

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

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00954148

Locations
United States, Texas
VA North Texas Health Care System
Dallas, Texas, United States, 75216
Sponsors and Collaborators
Dallas VA Medical Center
Investigators
Study Chair: James LePage, PH.D ACOS for Research VA North TX Health Care System
  More Information

No publications provided

Responsible Party: Thomas Anthony, MD Chief of Surgery, VANTXHCS Dallas, TX
ClinicalTrials.gov Identifier: NCT00954148     History of Changes
Other Study ID Numbers: 09-017
Study First Received: August 5, 2009
Last Updated: June 29, 2010
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by Dallas VA Medical Center:
cancer
colorectal
head/neck
lung
PET/CT

Additional relevant MeSH terms:
Recurrence
Neoplasms
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on May 19, 2013