PET-CT and Circulating Tumor Cells in Colorectal Cancer

Colorectal Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01163305
• Other study ID #: COL016
• Status: Completed
• Phase: N/A
• First received: June 24, 2010
• Last updated: May 3, 2017
• Start date: June 30, 2010
• Est. completion date: April 27, 2017

Study information

• Verified date: April 2017
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: April 27, 2017
• Est. primary completion date: April 27, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms
• Metastasis
• Neoplastic Cells, Circulating

Intervention

Drug:
• Chemotherapy
The majority of patients offered either oxaliplatin or irinotecan-based chemotherapy

Locations

Country	Name	City	State
Hong Kong	Department of Clinical Oncology, Prince of Wales Hospital	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tumor metabolic response via FDG-PET at 4 weeks after chemotherapy		2 years
Secondary	Overall survival		4 years
Secondary	Progression-free survival		4 years
Secondary	serum carcinoembryonic antigen (CEA) level		4 years
Secondary	Circulating tumor cells level changes at 4 weeks after chemotherapy		2 years
Secondary	RECIST-based tumor response at 10 weeks after chemotherapy		2 years