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PET-CT and Circulating Tumor Cells in Colorectal Cancer

This study has been completed.
Information provided by (Responsible Party):
CCTU, Chinese University of Hong Kong Identifier:
First received: June 24, 2010
Last updated: May 3, 2017
Last verified: April 2017
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.

Condition Intervention
Colorectal Cancer
Drug: Chemotherapy

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: 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

Resource links provided by NLM:

Further study details as provided by Chinese University of Hong Kong:

Primary Outcome Measures:
  • Tumor metabolic response via FDG-PET at 4 weeks after chemotherapy [ Time Frame: 2 years ]

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

Biospecimen Retention:   Samples With DNA
circulating tumor cells

Enrollment: 84
Actual Study Start Date: June 30, 2010
Study Completion Date: April 27, 2017
Primary Completion Date: April 27, 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
metastatic colorectal cancer Drug: Chemotherapy
The majority of patients offered either oxaliplatin or irinotecan-based chemotherapy

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).

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
patients with metastatic colorectal cancer

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01163305

Hong Kong
Department of Clinical Oncology, Prince of Wales Hospital
Hong Kong, Hong Kong
Sponsors and Collaborators
Chinese University of Hong Kong
Principal Investigator: Brigette Ma, MD, FRCP Department of Clinical Oncology, Prince of Wales Hospital, The Chinese University of Hong Kong
  More Information

Responsible Party: CCTU, Prof. Brigette Ma, Chinese University of Hong Kong Identifier: NCT01163305     History of Changes
Other Study ID Numbers: COL016
Study First Received: June 24, 2010
Last Updated: May 3, 2017

Keywords provided by Chinese University of Hong Kong:
Identifying an early indicator of drug efficacy

Additional relevant MeSH terms:
Colorectal Neoplasms
Neoplastic Cells, Circulating
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Neoplasm Metastasis
Neoplastic Processes
Pathologic Processes processed this record on May 22, 2017