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

Tracking Information

First Received Date ^ICMJE

June 24, 2010

Last Updated Date

May 14, 2013

Start Date ^ICMJE

June 2010

Estimated Primary Completion Date

June 2014 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Tumor metabolic response via FDG-PET at 4 weeks after chemotherapy [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01163305 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

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 ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

PET-CT and Circulating Tumor Cells in Colorectal Cancer

Official Title ^ICMJE

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 ^ICMJE

Observational

Study Design ^ICMJE

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 ^ICMJE

Colorectal Cancer
Metastasis

Intervention ^ICMJE

Drug: Chemotherapy

The majority of patients offered either oxaliplatin or irinotecan-based chemotherapy

Study Group/Cohort (s)

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 ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

June 2014

Estimated Primary Completion Date

June 2014 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

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

Location Countries ^ICMJE

Hong Kong

Administrative Information

NCT Number ^ICMJE

NCT01163305

Other Study ID Numbers ^ICMJE

COL016

Has Data Monitoring Committee

Responsible Party

CCTU, Chinese University of Hong Kong

Study Sponsor ^ICMJE

Chinese University of Hong Kong

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Brigette Ma, MD, FRCP

Department of Clinical Oncology, Prince of Wales Hospital, The Chinese University of Hong Kong

Information Provided By

Chinese University of Hong Kong

Verification Date

May 2013

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

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