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.

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer; Metastasis
• Intervention / Treatment: Drug: Chemotherapy

Detailed Description

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).

• Study Type: Observational
• Enrollment (Actual): 84

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

patients with metastatic colorectal cancer

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
metastatic colorectal cancer	Drug: Chemotherapy; The majority of patients offered either oxaliplatin or irinotecan-based chemotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Tumor metabolic response via FDG-PET at 4 weeks after chemotherapy	2 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Overall survival	4 years
Progression-free survival	4 years
serum carcinoembryonic antigen (CEA) level	4 years
Circulating tumor cells level changes at 4 weeks after chemotherapy	2 years
RECIST-based tumor response at 10 weeks after chemotherapy	2 years

Collaborators and Investigators

• Sponsor: 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

Study record dates

Study Major Dates

• Study Start (Actual): June 30, 2010
• Primary Completion (Actual): April 27, 2017
• Study Completion (Actual): April 27, 2017

Study Registration Dates

• First Submitted: June 24, 2010
• First Submitted That Met QC Criteria: July 14, 2010
• First Posted (Estimate): July 15, 2010

Study Record Updates

• Last Update Posted (Actual): May 8, 2017
• Last Update Submitted That Met QC Criteria: May 3, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: Identifying an early indicator of drug efficacy
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Neoplastic Processes; Neoplasm Metastasis; Colorectal Neoplasms; Neoplastic Cells, Circulating
• Other Study ID Numbers: COL016