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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2011 by Turku University Hospital
Sponsor:
Information provided by:
Turku University Hospital
ClinicalTrials.gov Identifier:
NCT00823810
First received: January 15, 2009
Last updated: November 10, 2011
Last verified: November 2011
  Purpose

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.


Condition Intervention
Colorectal Cancer
Other: PET/CT

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Treatment Monitoring of Advanced Colorectal Cancer With 18F-FDG PET/CT

Resource links provided by NLM:


Further study details as provided by Turku University Hospital:

Primary Outcome Measures:
  • Survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to progression [ Time Frame: One year ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: December 2008
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Colorectal cancer Other: PET/CT
18F-FDG PET/CT

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  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: NCT00823810

Contacts
Contact: Marko P Seppänen, MD, PhD +358 2 3130492 Marko.Seppanen@tyks.fi
Contact: Raija Ristamäki, MD, PhD +358 2 313 0000 Raija.Ristamaki@tyks.fi

Locations
Finland
Turku University Hospital Recruiting
Turku, Finland, 20521
Contact: Raija Ristamaki, MD,PhD       Raija.Ristamaki@tyks.fi   
Principal Investigator: Marko Seppänen, MD, PhD         
Sponsors and Collaborators
Turku University Hospital
  More Information

Additional Information:
No publications provided

Responsible Party: Marko Seppänen, Turku University Hospital
ClinicalTrials.gov Identifier: NCT00823810     History of Changes
Other Study ID Numbers: RESCORE
Study First Received: January 15, 2009
Last Updated: November 10, 2011
Health Authority: Finland: Finnish Medicines Agency

Keywords provided by Turku University Hospital:
Colorectal cancer
Response to treatment
FDG PET/CT

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on August 28, 2014