A randomised trial assessing the role of two new agents in the management of advanced colorectal cancer

Not Applicable

Completed

• Conditions: Cancer; Colorectal cancer; Malignant neoplasm of other and ill defined digestive organs

• Registration Number: ISRCTN79877428
• Lead Sponsor: Medical Research Council (MRC) Clinical Trials Unit (UK)

Brief Summary

1. 2005 ASCO Annual Meeting Proceedings abstract in http://meeting.ascopubs.org/cgi/content/abstract/23/16_suppl/3518 2. 2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17630037 3. 2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18509181 4. 2009 results on the association of molecular markers with toxicity outcomes in http://www.ncbi.nlm.nih.gov/pubmed/19858398 5. 2009 results on the effect of KRAS and BRAF mutations on efficacy of treatment agents in http://www.ncbi.nlm.nih.gov/pubmed/19884549

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2000-04-06
• Study Completion: 2003-12-31
• Last Update Posted: 12 November 2018

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 2100

Inclusion Criteria

1. Histologically confirmed adenocarcinoma of the colon or rectum
2. Inoperable disease (either locally advanced, recurrent or metastatic and not suitable for curative surgery or radiotherapy)
3. Measurable or evaluable disease
4. World Health Organization (WHO) performance status zero to two
5. Fit, able and willing to undergo any of the possible trial treatments and to comply with the quality of life questionnaires

Exclusion Criteria

1. White Blood Cells (WBC) less than 4 x 10^9/l
2. Platelets less than 150 x 10^9/l
3. Bilirubin more than 1.25 x Upper Limit of Normal (ULN)
4. Alkaline phosphatase more than 3 x ULN
5. Aspartate aminotransferase (AST) or Alanine aminotransferase (ALT) more than 3 x ULN
6. Renal impairment (calculated Creatinine Clearance [CrCl] less than 60 ml/min, or measured Glomerular Filtration Rate [GFR] below normal range)
7. Serious uncontrolled medical co-morbidity

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Survival from randomisation

Secondary Outcome Measures

Name	Time	Method
1. Time to failure of first-line treatment<br>2. Time to failure of protocol treatment plan<br>3. Objective response rate<br>4. Patient assessment of quality of life and acceptability of treatment, health economics