PET-CT and Circulating Tumor Cells in Colorectal Cancer
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ClinicalTrials.gov Identifier: NCT01163305 |
Recruitment Status
:
Completed
First Posted
: July 15, 2010
Last Update Posted
: May 8, 2017
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Condition or disease | Intervention/treatment |
---|---|
Colorectal Cancer Metastasis | Drug: Chemotherapy |
- 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.
- 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 |
Actual Enrollment : | 84 participants |
Observational Model: | Case-Only |
Time Perspective: | Prospective |
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 |
Actual Study Start Date : | June 30, 2010 |
Actual Primary Completion Date : | April 27, 2017 |
Actual Study Completion Date : | April 27, 2017 |

Group/Cohort | Intervention/treatment |
---|---|
metastatic colorectal cancer |
Drug: Chemotherapy
The majority of patients offered either oxaliplatin or irinotecan-based chemotherapy
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- Tumor metabolic response via FDG-PET at 4 weeks after chemotherapy [ Time Frame: 2 years ]
- Overall survival [ Time Frame: 4 years ]
- Progression-free survival [ Time Frame: 4 years ]
- serum carcinoembryonic antigen (CEA) level [ Time Frame: 4 years ]
- Circulating tumor cells level changes at 4 weeks after chemotherapy [ Time Frame: 2 years ]
- RECIST-based tumor response at 10 weeks after chemotherapy [ Time Frame: 2 years ]
Biospecimen Retention: Samples With DNA

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01163305
Hong Kong | |
Department of Clinical Oncology, Prince of Wales Hospital | |
Hong Kong, Hong Kong |
Principal Investigator: | Brigette Ma, MD, FRCP | Department of Clinical Oncology, Prince of Wales Hospital, The Chinese University of Hong Kong |
Responsible Party: | CCTU, Prof. Brigette Ma, Chinese University of Hong Kong |
ClinicalTrials.gov Identifier: | NCT01163305 History of Changes |
Other Study ID Numbers: |
COL016 |
First Posted: | July 15, 2010 Key Record Dates |
Last Update Posted: | May 8, 2017 |
Last Verified: | April 2017 |
Keywords provided by CCTU, Chinese University of Hong Kong:
Identifying an early indicator of drug efficacy |
Additional relevant MeSH terms:
Colorectal Neoplasms Neoplastic Cells, Circulating Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases |
Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases Neoplasm Metastasis Neoplastic Processes Pathologic Processes |