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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Neoplasms
Recurrence
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on October 23, 2014