PET-CT and Circulating Tumor Cells in Colorectal Cancer
This study is currently recruiting participants.
(see Contacts and Locations)
Verified January 2016 by Chinese University of Hong Kong
Sponsor:
Chinese University of Hong Kong
Information provided by (Responsible Party):
CCTU, Chinese University of Hong Kong
ClinicalTrials.gov Identifier:
NCT01163305
First received: June 24, 2010
Last updated: January 28, 2016
Last verified: January 2016
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Colorectal Cancer Metastasis |
Drug: Chemotherapy |
| Study Type: | Observational |
| Study Design: | 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 |
Resource links provided by NLM:
Further study details as provided by Chinese University of Hong Kong:
Primary Outcome Measures:
- Tumor metabolic response via FDG-PET at 4 weeks after chemotherapy [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Overall survival [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
- Progression-free survival [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
- serum carcinoembryonic antigen (CEA) level [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
- Circulating tumor cells level changes at 4 weeks after chemotherapy [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
- RECIST-based tumor response at 10 weeks after chemotherapy [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
Biospecimen Retention: Samples With DNA
circulating tumor cells
| Estimated Enrollment: | 96 |
| Study Start Date: | June 2010 |
| Estimated Study Completion Date: | June 2016 |
| Estimated Primary Completion Date: | June 2016 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
| metastatic colorectal cancer |
Drug: Chemotherapy
The majority of patients offered either oxaliplatin or irinotecan-based chemotherapy
|
Detailed Description:
- 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).
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Study Population
patients with metastatic colorectal cancer
Criteria
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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01163305
Please refer to this study by its ClinicalTrials.gov identifier: NCT01163305
Contacts
| Contact: Brigette Ma, MD, FRCP | 2632 ext 1042 | brigette@clo.cuhk.edu.hk | |
| Contact: Rosalie Ho, RN | 2632 ext 1135 | rosalie@clo.cuhk.edu.hk |
Locations
| Hong Kong | |
| Department of Clinical Oncology, Prince of Wales Hospital | Recruiting |
| Hong Kong, Hong Kong | |
| Contact: Brigette Ma, MD, FRCP 2632 ext 1042 brigette@clo.cuhk.edu.hk | |
| Contact: Rosalie Ho, RN 2632 ext 1135 rosalie@clo.cuhk.edu.hk | |
| Sub-Investigator: Anthony Chan, MD, FRCP | |
| Sub-Investigator: Ann King, MD | |
| Sub-Investigator: Cesar Wong, PhD | |
Sponsors and Collaborators
Chinese University of Hong Kong
Investigators
| Principal Investigator: | Brigette Ma, MD, FRCP | Department of Clinical Oncology, Prince of Wales Hospital, The Chinese University of Hong Kong |
More Information
| Responsible Party: | CCTU, Prof. Brigette Ma, Chinese University of Hong Kong |
| ClinicalTrials.gov Identifier: | NCT01163305 History of Changes |
| Other Study ID Numbers: | COL016 |
| Study First Received: | June 24, 2010 |
| Last Updated: | January 28, 2016 |
| Health Authority: | Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee |
Keywords provided by 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 |
ClinicalTrials.gov processed this record on September 28, 2016