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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
Sponsor:
Information provided by (Responsible Party):
CCTU, Chinese University of Hong Kong

Study Description
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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.

Condition or disease Intervention/treatment
Colorectal Cancer Metastasis Drug: Chemotherapy

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).

Study Design
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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

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts
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Group/Cohort Intervention/treatment
metastatic colorectal cancer Drug: Chemotherapy
The majority of patients offered either oxaliplatin or irinotecan-based chemotherapy


Outcome Measures
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Primary Outcome Measures :
  1. Tumor metabolic response via FDG-PET at 4 weeks after chemotherapy [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Overall survival [ Time Frame: 4 years ]
  2. Progression-free survival [ Time Frame: 4 years ]
  3. serum carcinoembryonic antigen (CEA) level [ Time Frame: 4 years ]
  4. Circulating tumor cells level changes at 4 weeks after chemotherapy [ Time Frame: 2 years ]
  5. RECIST-based tumor response at 10 weeks after chemotherapy [ Time Frame: 2 years ]

Biospecimen Retention:   Samples With DNA
circulating tumor cells

Eligibility Criteria
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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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
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
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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


Locations
Hong Kong
Department of Clinical Oncology, Prince of Wales Hospital
Hong Kong, Hong Kong
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
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations 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
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