Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000776000
Ethics application status
Approved
Date submitted
7/09/2010
Date registered
16/09/2010
Date last updated
15/02/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
The use of novel protein biomarkers in predicting clinical outcomes in patients with localised and metastatic colorectal cancer
Scientific title
The use of novel protein biomarkers in predicting clinical outcomes in patients with localised and metastatic colorectal cancer
Secondary ID [1] 252651 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Colorectal cancer 258146 0
Condition category
Condition code
Cancer 258325 258325 0 0
Bowel - Back passage (rectum) or large bowel (colon)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Predictive biomarker (plasma proteomics) study.

This is a prognostic/ predictive factor study investigating the utility of plasma proteomics in predicting toxicity and patient outcomes for patients with metastatic colorectal cancer. Plasma (2 10ml Tubes) is collected at 4 time points- (1) day 7-10 prior to chemotherapy, (2) prior to starting chemotherapy at day 1, (3) Day 3 of chemotherapy and (4) Day 15 of chemotherapy.

The decision to take either at Day 7 or 10 prior to chemotherapy is dependent on the day patients are reviewed in clinic and/ or convenience. This timepoint is to make sure there is no variation at this time period and the day of starting chemotherapy.

The types of chemotherapy are 5-fluorouracil based infusional chemotherapy which are undertaken on a 14 day cycle. In general, patients receiving adjuvant chemotherapy have 12 cycles (6 months of chemotherapy). There is no set number of cycles of chemotherapy for patients with metastatic disease and is physician discreation and ondividual patient response. In general, patients receive at least 4 cycles of chemotherapy prior to evaluation of response. This study is also recruiting patients not having chemotherapy and investigating the role of protoemics in predicting the development of cancer cachexia.
Intervention code [1] 257160 0
Other interventions
Intervention code [2] 257218 0
Diagnosis / Prognosis
Comparator / control treatment
Nil
Control group
Uncontrolled

Outcomes
Primary outcome [1] 259178 0
Haematological and non-haematological toxicity after first 2 cycles of chemotherapy.

Haemotological assessment will be performed through collection of full blood count and assessed using the National Cancer Institute (NCI) Toxicity Criteria. Similarly, non-haematological tooxicity will be assessed using NCI criteria thorugh patients diaries and interview with clinical trials staff.
Timepoint [1] 259178 0
At the end of cycle 1 (at Day 15) and end of cycle 2 (day 29) of chemotherapy
Secondary outcome [1] 265524 0
Response rate (for patients with metastatic disease)
Timepoint [1] 265524 0
Response rate after 4 cycles of treatment
Assessment through radiological scans (computed tomography or CT) by an independet reviewer using specified criteria.
Secondary outcome [2] 265552 0
Progression free survival
Timepoint [2] 265552 0
Time of progression based on radiologial scans as above. Patients are followed up for evidence of progression/death every 8 weeks (for those with metastatic disease) or 16 weeks (those with locally advanced disease).
Secondary outcome [3] 265553 0
Overall survival
Timepoint [3] 265553 0
Time of progression based on radiologial scans as above. Patients are followed up for evidence of progression/death every 8 weeks (for those with metastatic disease) or 16 weeks (those with locally advanced disease).

Eligibility
Key inclusion criteria
Patients with biopsy proven metastatic or locally advanced colorectal cancer starting chemotherapy involving infusional 5-fluoroouracil or

Patients with biopsy proven metastatic colorectal cancer for symotomatic management only

AND

Eastern Cooperative Oncology Group (ECOG) performance status 0-2 AND
age over 18 years AND
ability to comply and provide informed written consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Pior chemotherapy for metastatic colorectal cancer or adjuvant chemotherapy in the last 6 months

Other active malignancy

Active autoimmune, inflammatory disease or infection

Symptoms and signs of cancer cachexia

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
26/11/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 257615 0
Government body
Name [1] 257615 0
Cancer Institute NSW
Country [1] 257615 0
Australia
Primary sponsor type
Government body
Name
Cancer Institute NSW
Address
Australian Technology Park
Biomedical Building
Suite 101
1 Central Avenue (off Garden Road)
EVELEIGH NSW 2015
Australia
Country
Australia
Secondary sponsor category [1] 256837 0
None
Name [1] 256837 0
Address [1] 256837 0
Country [1] 256837 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
This study is investigating the utility of a novel technique called 'proteomics' using serial blood samples to see if there are differences in plasma proteins whicn are able to predict toxicity and patient response to chemotherapy for patients with colorectal cancer.

The hypothesis is that proteomic techniques are able to
(1) identify patients more likely to respond to chemotherapy and predict overall outcome
(2) identify patients more likely to expereince side effects and
(3) predict the development of cancer cachexia in patients with metastatic colorectal cancer

The intervention is the collection of blood samples at 4 time points during chemotherapy or observation. In addition there will be standard care (radiological and nutritional assessment) plus follow up as set out by the trial protocol.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31618 0
Address 31618 0
Country 31618 0
Phone 31618 0
Fax 31618 0
Email 31618 0
Contact person for public queries
Name 14865 0
Wei Chua
Address 14865 0
Sydney Cancer Centre
Department of Medical Oncology
Building 76, Hospital Road
Concord Repatriation General Hospital
Concord NSW 2139
Country 14865 0
Australia
Phone 14865 0
612 9767 6354
Fax 14865 0
Email 14865 0
weic@med.usyd.edu.au
Contact person for scientific queries
Name 5793 0
Stephen J Clarke
Address 5793 0
Sydney Cancer Centre
Department of Medical Oncology
Building 76, Hospital Road
Concord Repatriation General Hospital
Concord NSW 2139
Country 5793 0
Australia
Phone 5793 0
612 9767 6775
Fax 5793 0
Email 5793 0
stephen.clarke@sydney.edu.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.