PET-CT and Circulating Tumor Cells in Colorectal Cancer

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT01163305

First Posted: July 15, 2010

Last Update Posted: May 8, 2017

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Information provided by (Responsible Party):

CCTU, Chinese University of Hong Kong

Tracking Information

First Submitted Date

June 24, 2010

First Posted Date

July 15, 2010

Last Update Posted Date

May 8, 2017

Actual Start Date

June 30, 2010

Primary Completion Date

April 27, 2017 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures

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

Original Primary Outcome Measures

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

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

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

Enrollment

Completion Date

April 27, 2017

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, Senior)

Accepts Healthy Volunteers

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

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

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