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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00954148
Other study ID # 09-017
Secondary ID
Status Terminated
Phase N/A
First received August 5, 2009
Last updated June 29, 2010
Start date September 2009
Est. completion date June 2010

Study information

Verified date May 2010
Source Dallas VA Medical Center
Contact n/a
Is FDA regulated No
Health authority United States: Federal GovernmentUnited States: Institutional Review Board
Study type Interventional

Clinical Trial 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).


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


Recruitment information / eligibility

Status Terminated
Enrollment 53
Est. completion date June 2010
Est. primary completion date May 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 90 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Diagnostic


Related Conditions & MeSH terms


Intervention

Procedure:
PET/CT
5 visits with PET/CT as only testing
NCCN recommendations for solid tumor post treatment
12-14 visits with exams, blood tests, CTs and PET/CT

Locations

Country Name City State
United States VA North Texas Health Care System Dallas Texas

Sponsors (1)

Lead Sponsor Collaborator
Dallas VA Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
Secondary Improvement in patient/caregiver compliance in keeping their appointments and completing their tests 5 years No
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