FOCUS 3 - Feasibility of molecular selection using K-ras and topo-1.

• Research type

  Research Study

• Full title

  FOCUS 3 A study to determine the feasibility of molecular selection of therapy using K-ras and topo-1 in patients with metastatic or locally advanced colorectal cancer.

• IRAS ID

  14301

• Sponsor organisation

  Medical Research Council

• Eudract number

  2008-008323-15

• ISRCTN Number

  pending

• Research summary

  There are now molecular tests that can be done on tumour samples from patients with advanced colorectal cancer which may help selection of the best treatment options for an individual patient. FOCUS 3 will look at the feasibility of this approach in the UK NHS setting. 240 patients will be randomised to the trial at 20 centres across the UK.Two tests will be performed on the tumour before a patient is considered eligible for randomisation: the first will assess the levels of a protein called topo-1 and the second will assess K-ras status. K-ras is one of the genes often altered in colorectal cancer. About half of patients with colorectal cancer have low levels of topo-1 and half have high levels. Similarly, about 40% of patients with colorectal cancer have a change (mutation) in the K-ras gene and 60% do not. When the tests are completed, the cancer will be classed as one of four molecular types, and thus give four sub-groups of patients:<ul> <li style="color: Type 1: low topo-1, K-ras normal</li> <li style="color: Type 2: low topo-1, K-ras mutation</li> <li style="color: Type 3: high topo-1, K-ras normal</li> <li style="color: Type 4: high topo-1, K-ras mutation</li></ul>Within each subgroup each patient will be randomised to one of 3 arms; a control arm which is common to each of the 4 subgroups and two alternative, research arms. The control arm (A) is irinotecan anflurouracil. The two alternative research arms will depend on the molecular type of the tumour and will include the following regimens: (Bflurouracil, (C) irinotecan, oxaliplatin anflurouracil, (D)irinotecanflurouracil and cetuximab, and (E) irinotecanflurouracil and bevacizumab.The primary aims of the trial are to test the feasibility of testing tumour samples before randomisation and will look at whether results of the tests can be provided within 10 working days to allow randomisation.

• REC name

  Wales REC 3

• REC reference

  09/MRE09/28

• Date of REC Opinion

  26 May 2009

• REC opinion

  Further Information Favourable Opinion