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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01163305

Enrollment

Registered

2010-07-15

Start date

2010-06-30

Completion date

2017-04-27

Last updated

2017-05-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer, Metastasis

Keywords

Identifying an early indicator of drug efficacy

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).

Interventions

DRUGChemotherapy

The majority of patients offered either oxaliplatin or irinotecan-based chemotherapy

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

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

Countries

Hong Kong

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 8, 2026