The use of novel protein biomarkers in predicting clinical outcomes in patients with localised and metastatic colorectal cancer

Not Applicable

Recruiting

• Conditions: Colorectal cancer; Cancer - Bowel - Back passage (rectum) or large bowel (colon)

• Registration Number: ACTRN12610000776000
• Lead Sponsor: Cancer Institute NSW

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-09-16
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 200

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

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

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Haematological and non-haematological toxicity after first 2 cycles of chemotherapy.<br><br>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.[At the end of cycle 1 (at Day 15) and end of cycle 2 (day 29) of chemotherapy]

Secondary Outcome Measures

Name	Time	Method
Response rate (for patients with metastatic disease)[Response rate after 4 cycles of treatment<br>Assessment through radiological scans (computed tomography or CT) by an independet reviewer using specified criteria.];Progression free survival[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).];Overall survival[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).]