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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


N/A
18 Years
N/A
Open (Enrolling)
Both
Colorectal Cancer, Metastasis

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Trial Information

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


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).


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

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

Tumor metabolic response via FDG-PET at 4 weeks after chemotherapy

Outcome Time Frame:

2 years

Safety Issue:

Yes

Principal Investigator

Brigette Ma, MD, FRCP

Investigator Role:

Principal Investigator

Investigator Affiliation:

Department of Clinical Oncology, Prince of Wales Hospital, The Chinese University of Hong Kong

Authority:

Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee

Study ID:

COL016

NCT ID:

NCT01163305

Start Date:

June 2010

Completion Date:

June 2014

Related Keywords:

  • Colorectal Cancer
  • Metastasis
  • Identifying an early indicator of drug efficacy
  • Colorectal Neoplasms
  • Neoplastic Cells, Circulating
  • Neoplasm Metastasis

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