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PET-CT and Circulating Tumor Cells in Colorectal Cancer

This study is currently recruiting participants.
Verified May 2013 by Chinese University of Hong Kong
Sponsor:
Information provided by (Responsible Party):
CCTU, Chinese University of Hong Kong
ClinicalTrials.gov Identifier:
NCT01163305
First received: June 24, 2010
Last updated: May 14, 2013
Last verified: May 2013
History of Changes
  Purpose

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
Metastasis
 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:

U.S. FDA Resources

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 ] [ Designated as safety issue: Yes ]

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

Biospecimen Retention:   Samples With DNA

circulating tumor cells


Estimated Enrollment: 96
Study Start Date: June 2010
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (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).
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

patients with metastatic colorectal cancer

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01163305

Contacts
Contact: Brigette Ma, MD, FRCP 2632 ext 1042 brigette@clo.cuhk.edu.hk
Contact: Rosalie Ho, RN 2632 ext 1135 rosalie@clo.cuhk.edu.hk

Locations
Hong Kong
Department of Clinical Oncology, Prince of Wales Hospital Recruiting
Hong Kong, Hong Kong
Contact: Brigette Ma, MD, FRCP     2632 ext 1042     brigette@clo.cuhk.edu.hk    
Contact: Rosalie Ho, RN     2632 ext 1135     rosalie@clo.cuhk.edu.hk    
Sub-Investigator: Anthony Chan, MD, FRCP            
Sub-Investigator: Ann King, MD            
Sub-Investigator: Cesar Wong, PhD            
Sponsors and Collaborators
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
  More Information

No publications provided

Responsible Party: CCTU, Prof. Brigette Ma, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT01163305     History of Changes
Other Study ID Numbers: COL016
Study First Received: June 24, 2010
Last Updated: May 14, 2013
Health Authority: Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee

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

Additional relevant MeSH terms:
Colorectal Neoplasms
Neoplastic Cells, Circulating
Neoplasm Metastasis
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
 Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Neoplastic Processes
Pathologic Processes

ClinicalTrials.gov processed this record on May 16, 2013