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

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:

MedlinePlus related topics: Colorectal Cancer

U.S. FDA Resources

Further study details as provided by CCTU, Chinese University of Hong Kong:

Primary Outcome Measures:

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

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 ]

Biospecimen Retention: Samples With DNA

circulating tumor cells


Enrollment:	84
Actual Study Start Date:	June 30, 2010
Study Completion Date:	April 27, 2017
Primary Completion Date:	April 27, 2017 (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:

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).

Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01163305

Locations


Hong Kong
Department of Clinical Oncology, Prince of Wales Hospital
Hong Kong, Hong Kong

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


Responsible Party:	CCTU, Prof. Brigette Ma, Chinese University of Hong Kong
ClinicalTrials.gov Identifier:	NCT01163305 History of Changes
Other Study ID Numbers:	COL016
First Submitted:	June 24, 2010
First Posted:	July 15, 2010
Last Update Posted:	May 8, 2017
Last Verified:	April 2017

Keywords provided by CCTU, Chinese University of Hong Kong:


Identifying an early indicator of drug efficacy

Additional relevant MeSH terms:


Colorectal Neoplasms Neoplastic Cells, Circulating Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases	Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases Neoplasm Metastasis Neoplastic Processes Pathologic Processes

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