NCT01163305

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2010

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 24, 2010

Completed
6 days until next milestone

Study Start

First participant enrolled

June 30, 2010

Completed
15 days until next milestone

First Posted

Study publicly available on registry

July 15, 2010

Completed
6.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 27, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 27, 2017

Completed
Last Updated

May 8, 2017

Status Verified

April 1, 2017

Enrollment Period

6.8 years

First QC Date

June 24, 2010

Last Update Submit

May 3, 2017

Conditions

Colorectal CancerMetastasis

Keywords

Identifying an early indicator of drug efficacy

Outcome Measures

Primary Outcomes (1)

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

    2 years

Secondary Outcomes (5)

  • Overall survival

    4 years

  • Progression-free survival

    4 years

  • serum carcinoembryonic antigen (CEA) level

    4 years

  • Circulating tumor cells level changes at 4 weeks after chemotherapy

    2 years

  • RECIST-based tumor response at 10 weeks after chemotherapy

    2 years

Study Arms (1)

metastatic colorectal cancer

Drug: Chemotherapy

Interventions

ChemotherapyDRUG

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

metastatic colorectal cancer

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

patients with metastatic colorectal cancer

You may qualify if:

  • 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

You may not qualify if:

  • Patients with diabetes mellitus
  • presence of hyperglycemia
  • Pregnant or lactating patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Clinical Oncology, Prince of Wales Hospital

Hong Kong, Hong Kong

Location

Biospecimen

Retention: SAMPLES WITH DNA

circulating tumor cells

MeSH Terms

Conditions

Colorectal NeoplasmsNeoplasm Metastasis

Interventions

Drug Therapy

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Brigette Ma, MD, FRCP

    Department of Clinical Oncology, Prince of Wales Hospital, The Chinese University of Hong Kong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Brigette Ma

Study Record Dates

First Submitted

June 24, 2010

First Posted

July 15, 2010

Study Start

June 30, 2010

Primary Completion

April 27, 2017

Study Completion

April 27, 2017

Last Updated

May 8, 2017

Record last verified: 2017-04

Locations

HK(1)