PET-CT and Circulating Tumor Cells in Colorectal Cancer

Completed

• Conditions: Colorectal Cancer; Metastasis
• Interventions: Drug: Chemotherapy

• Registration Number: NCT01163305
• Lead Sponsor: Chinese University of Hong Kong

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

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 Timeline

• Study First Submitted: 2010-06-24
• Study Start: 2010-06-30
• Study First Submitted QC: 2010-07-14
• Study First Posted: 2010-07-15
• Status Verified: 2017-04
• Primary Completion: 2017-04-27
• Study Completion: 2017-04-27
• Last Update Submitted: 2017-05-03
• Last Update Posted: 2017-05-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 84

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

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Exclusion Criteria

• Patients with diabetes mellitus
• presence of hyperglycemia
• Pregnant or lactating patients

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
metastatic colorectal cancer	Chemotherapy	-

Primary Outcome Measures

Name	Time	Method
Tumor metabolic response via FDG-PET at 4 weeks after chemotherapy	2 years

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Department of Clinical Oncology, Prince of Wales Hospital; 🇭🇰 Hong Kong, Hong Kong