PET-CT and Circulating Tumor Cells in Colorectal Cancer

This study is currently recruiting participants.
Verified November 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: November 12, 2013
Last verified: November 2013

June 24, 2010
November 12, 2013
June 2010
June 2014   (final data collection date for primary outcome measure)
Tumor metabolic response via FDG-PET at 4 weeks after chemotherapy [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01163305 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 ]
Not Provided
Not Provided
 
PET-CT and Circulating Tumor Cells in Colorectal Cancer
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.

  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).
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

circulating tumor cells

Probability Sample

patients with metastatic colorectal cancer

  • Colorectal Cancer
  • Metastasis
Drug: Chemotherapy
The majority of patients offered either oxaliplatin or irinotecan-based chemotherapy
metastatic colorectal cancer
Intervention: Drug: Chemotherapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
96
June 2014
June 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
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
Hong Kong
 
NCT01163305
COL016
No
CCTU, Chinese University of Hong Kong
Chinese University of Hong Kong
Not Provided
Principal Investigator: Brigette Ma, MD, FRCP Department of Clinical Oncology, Prince of Wales Hospital, The Chinese University of Hong Kong
Chinese University of Hong Kong
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP