Treatment Monitoring of Advanced Colorectal Cancer With 18F-FDG PET/CT

Colorectal Cancer Clinical Trial

— RESCORE  

Official title:

Treatment Monitoring of Advanced Colorectal Cancer With 18F-FDG PET/CT

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00823810
• Other study ID #: RESCORE
• Status: Terminated
• Phase: N/A
• First received: January 15, 2009
• Last updated: October 8, 2014
• Start date: December 2008
• Est. completion date: December 2011

Study information

• Verified date: October 2014
• Source: Turku University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Finnish Medicines Agency
• Study type: Interventional

Clinical Trial Summary

Measuring tumor response to treatment based on computed tomography (CT) and/or magnetic resonance imaging (MRI) has been a widely debated issue (response criteria in solid tumors [RECIST] and World Health Organization criteria). Furthermore, early identification of nonresponding patients is of great importance because the rates of response of common malignant solid tumors to chemotherapy are in the range of only 20-30%. Therefore, quantitative imaging of tumor metabolism with 18F-FDG PET/CT may provide important advantages and thus reduce side effects and costs of ineffective therapy. However, the evidence to date for the use of 18F-FDG-PET/CT with this indication is limited.

The purpose of the present trial is to determine the impact of 18F-FDG PET/CT in the management of advanced colorectal cancer. The aim is also to confirm whether a metabolic response can be used as a surrogate end point in monitoring treatment response in this cancer type.

The study consists of 40 patients with advanced colorectal cancer patients. All patients will be studied with 18F-FDG PET/CT combined with diagnostic contrast enhanced abdominal CT before the start of chemotherapy and re-evaluated 4-5 weeks after the initiation of therapy. Effect of this metabolic and anatomic change in therapy are evaluated and correlated to survival, morbidity, and treatment -related costs. Histopathologic confirmation of response is evaluated whenever possible. The data will be collected between 2008 and 2012.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 20
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 80 Years

Eligibility

Inclusion Criteria:

• Age 40 to 80 years old

• Language spoken: Finnish or Swedish

• Performance status: Karnofsky score 70 or better or WHO performance status 2 or better

• earlier diagnosed (histologically confirmed) colorectal cancer with discovered metastases at operation

• Earlier diagnosed and treated colorectal cancer with discovered recurrence in the follow up

• Mental status: Patients must be able to understand the meaning of the study

• Informed consent: The patient must sign the appropriate Ethical Committee (EC) approved informed consent documents in the presence of the designated staff

Exclusion Criteria:

• Prior medical history: Patient must have no history of serious cardiovascular, liver or kidney disease

• Vulnerable study subjects such as described in Finnish law concerning clinical studies (disabled, children, pregnant or breast-feeding women, prisoners) will not be included.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Other:
• PET/CT
18F-FDG PET/CT

Locations

Country	Name	City	State
Finland	Turku University Hospital	Turku

Sponsors (1)

Lead Sponsor	Collaborator
Turku University Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival		2 years	No
Secondary	Time to progression		One year	No

External Links

•   Turku PET Centre