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NCT Number: NCT01163305

PET-CT and Circulating Tumor Cells in Colorectal Cancer

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.

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Key information

Conditions

Colorectal Cancer Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Metastasis Neoplasm Metastasis Neoplasms Neoplasms by Site Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms Rectal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Clinical Oncology, Prince of Wales Hospital

Hong Kong

About this study

  • 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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Chemotherapy

Drug

The majority of patients offered either oxaliplatin or irinotecan-based chemotherapy

Primary outcomes

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

    Time frame: 2 years

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2017
Study completion
2017
First posted
Jul 15, 2010
Registry last updated
May 8, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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