PET-CT and Circulating Tumor Cells in Colorectal Cancer

Tracking Information
First Submitted Date	June 24, 2010
First Posted Date	July 15, 2010
Last Update Posted Date	May 8, 2017
Actual Study Start Date	June 30, 2010
Actual Primary Completion Date	April 27, 2017 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures; (submitted: July 28, 2010)	Tumor metabolic response via FDG-PET at 4 weeks after chemotherapy [ Time Frame: 2 years ]
Original Primary Outcome Measures; (submitted: July 14, 2010)	Tumor metabolic response via FDG-PET at 4 weeks after chemotherapy [ Time Frame: 2 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 ]
Change History	Complete list of historical versions of study NCT01163305 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures; (submitted: July 28, 2010)	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 ]
Original Secondary Outcome Measures; (submitted: July 14, 2010)	Overall survival [ Time Frame: 4 years ]; Progression-free survival [ Time Frame: 4 years ]; serum carcinoembryonic antigen (CEA) level [ Time Frame: 4 years ]
Current Other Outcome Measures	Not Provided
Original Other Outcome Measures	Not Provided
Descriptive Information
Brief Title	PET-CT and Circulating Tumor Cells in Colorectal Cancer
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
Brief Summary	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.
Detailed Description	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.; 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
Study Design	Observational Model: Case-Only; Time Perspective: Prospective
Target Follow-Up Duration	Not Provided
Biospecimen	Retention: Samples With DNA; Description: circulating tumor cells
Sampling Method	Probability Sample
Study Population	patients with metastatic colorectal cancer
Condition	Colorectal Cancer; Metastasis
Intervention	Drug: Chemotherapy; The majority of patients offered either oxaliplatin or irinotecan-based chemotherapy
Study Groups/Cohorts	metastatic colorectal cancer; Intervention: Drug: Chemotherapy
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status	Completed
Actual Enrollment; (submitted: May 3, 2017)	84
Original Estimated Enrollment; (submitted: July 14, 2010)	96
Actual Study Completion Date	April 27, 2017
Actual Primary Completion Date	April 27, 2017 (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years and older (Adult, Older Adult)
Accepts Healthy Volunteers	No
Contacts	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries	Hong Kong
Removed Location Countries
Administrative Information
NCT Number	NCT01163305
Other Study ID Numbers	COL016
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	CCTU, Chinese University of Hong Kong
Study Sponsor	Chinese University of Hong Kong
Collaborators	Not Provided
Investigators	Principal Investigator: Brigette Ma, MD, FRCP Department of Clinical Oncology, Prince of Wales Hospital, The Chinese University of Hong Kong
PRS Account	Chinese University of Hong Kong
Verification Date	April 2017