A randomised controlled trial to determine the feasibility of molecular selection of therapy using KRAS, BRAF and topo-1 in patients with metastatic or locally advanced colorectal cancer

Medical Research Council (UK)0 sites240 target enrollmentJuly 24, 2009

Overview

Registry

who.int

Start Date

July 24, 2009

End Date

March 31, 2011

Last Updated

3 years ago

Study Type

Interventional

Sex

All

Sponsor

Medical Research Council (UK)

•Amendments as of 09/02/2010:
•Please note that as of the above date, point 4 below was updated as follows:
•4\. Unidimensionally measurable disease (Response Evaluation Criteria in Solid Tumours \[RECIST] criteria). Baseline computed tomography (CT) scan must be performed within 5 weeks prior to treatment.
•Initial inclusion criteria at time of registration:
•1\. Male/female patients aged at least 18 years or over
•2\. Confirmed colorectal adenocarcinoma:
•2\.1\. Either previous or current histologically confirmed primary adenocarcinoma of colon or rectum, together with clinical or radiological evidence of locally advanced disease or metastatic disease or both
•2\.2\. Or histologically confirmed metastatic adenocarcinoma, together with clinical and/or radiological evidence of colorectal primary tumour
•3\. Inoperable metastatic or locoregional disease
•4\. Unidimensionally measurable disease (Response Evaluation Criteria in Solid Tumours \[RECIST] criteria). Baseline computed tomography (CT) scan must be performed within 4 weeks prior to treatment.

•1\. Patients expected to be suitable for surgical resection of metastatic disease after response to chemotherapy as decided by the multidisciplinary team (MDT)
•2\. Previous systemic chemotherapy for metastatic disease
•3\. Pregnant or lactating women
•4\. Inability to attend or comply with treatment or follow\-up scheduling
•5\. Patients who are unfit for the chemotherapy regimens in this protocol, e.g.:
•5\.1\. Severe uncontrolled concurrent medical illness (including poorly controlled angina, uncontrolled hypertension or very recent myocardial infarction (MI) (i.e. in previous 3 months), likely to interfere with protocol treatments
•5\.2\. History of severe peptic ulcer diseases
•5\.3\. Any psychiatric or neurological condition which is felt likely to compromise the patient's ability to give informed consent or to comply with oral medication
•5\.4\. Nephrotic syndrome
•5\.5\. Known coagulopathy