PET-CT and Circulating Tumor Cells in Colorectal Cancer

May 3, 2017 updated by: CCTU, Chinese University of Hong Kong

Identifying an Early Indicator of Drug Efficacy in Patients With Advanced Colorectal Cancer - a Prospective Evaluation of Circulating Tumor Cells, Positron-emission Tomography Scan and RECIST Criteria

The purpose of this study is to identify an early indicator of drug efficacy in patients with advanced colorectal cancer - a prospective evaluation of circulating tumor cells, positron-emission tomography scan and RECIST criteria.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

  1. To determine if measuring both tumor metabolic response (via FDG-PET scan) & circulating tumor cells (CirTC) at 4 weeks after starting treatment, is a better predictor of clinical outcome than measuring either modality alone in patients with metastatic colorectal cancer (CRC) who are undergoing first-line oxaliplatin-based chemotherapy.
  2. To determine if a new method of assessing drug response (measuring tumor metabolic response via FDG-PET & CirTC at 4 weeks after starting treatment) better predicts clinical outcome than the conventional method (measuring radiological changes in tumor dimensions at 10 weeks after starting treatment via the 'Response Evaluation Criteria in Solid Tumors' - RECIST).

Study Type

Observational

Enrollment (Actual)

84

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • Department of Clinical Oncology, Prince of Wales Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

patients with metastatic colorectal cancer

Description

Inclusion Criteria:

  • Metastatic colorectal cancer patients not received prior drug treatment for metastatic CRC
  • Age >= 18 years
  • (ECOG) performance status of 0-2
  • Measurable tumor sites by RECIST criteria
  • Adequate bone marrow, renal & hepatic functions

Exclusion Criteria:

  • Patients with diabetes mellitus
  • presence of hyperglycemia
  • Pregnant or lactating patients

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
metastatic colorectal cancer
Drug: Chemotherapy
The majority of patients offered either oxaliplatin or irinotecan-based chemotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Tumor metabolic response via FDG-PET at 4 weeks after chemotherapy
Time Frame: 2 years
2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall survival
Time Frame: 4 years
4 years
Progression-free survival
Time Frame: 4 years
4 years
serum carcinoembryonic antigen (CEA) level
Time Frame: 4 years
4 years
Circulating tumor cells level changes at 4 weeks after chemotherapy
Time Frame: 2 years
2 years
RECIST-based tumor response at 10 weeks after chemotherapy
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese University of Hong Kong

Investigators

  • Principal Investigator: Brigette Ma, MD, FRCP, Department of Clinical Oncology, Prince of Wales Hospital, The Chinese University of Hong Kong

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 30, 2010

Primary Completion (Actual)

April 27, 2017

Study Completion (Actual)

April 27, 2017

Study Registration Dates

First Submitted

June 24, 2010

First Submitted That Met QC Criteria

July 14, 2010

First Posted (Estimate)

July 15, 2010

Study Record Updates

Last Update Posted (Actual)

May 8, 2017

Last Update Submitted That Met QC Criteria

May 3, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • COL016

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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