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PET-CT and Circulating Tumor Cells in Colorectal Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Chinese University of Hong Kong
Sponsor:
Information provided by (Responsible Party):
CCTU, Chinese University of Hong Kong
ClinicalTrials.gov Identifier:
NCT01163305
First received: June 24, 2010
Last updated: May 21, 2014
Last verified: May 2014
  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: December 2014
Estimated Primary Completion Date: December 2014 (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:
  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).
  Eligibility

Ages Eligible for Study:   18 Years and older
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

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

No publications provided

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: May 21, 2014
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
Colonic Diseases
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Neoplasm Metastasis
Neoplasms
Neoplasms by Site
Neoplastic Processes
Pathologic Processes
Rectal Diseases

ClinicalTrials.gov processed this record on November 25, 2014