FOCUS 3A study to determine the feasibility of molecular selection of therapy using KRAS, BRAF and topo-1 in patients with metastatic or locally advanced colorectal cancer. - FOCUS 3-Feasibility of molecular selection using KRAS, BRAF and topo-1
- Conditions
- metastatic or locally advanced colorectal cancerMedDRA version: 9.1Level: LLTClassification code 10052362Term: metastatic colorectal cancer
- Registration Number
- EUCTR2008-008323-15-GB
- Lead Sponsor
- Medical Research Council
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Patient inclusion criteria
1.Male/Female patients at least 18 years or over.
2.Confirmed colorectal adenocarcinoma:
-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
-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. Baseline CT scan must be performed within 4 weeks prior to treatment
5.Adjuvant chemotherapy with 5FU +/- FA, capecitabine or oxaliplatin combinations may have been given, if chemotherapy completed at least 6 months prior to trial entry. QUASAR 2 patients who have continued bevacizumab for 6 months following completion of chemotherapy are eligible immediately following completion of bevacizumab (Avastin).
6.Rectal chemoradiotherapy with 5FU +/- FA or capecitabine may have been given, if completed at least 1 month prior to trial entry
7.Fit to receive any of the treatment regimens proposed as defined by:
-WHO performance status (PS) 0, 1 or 2 and considered by responsible consultant to be fit to undergo combination chemotherapy.
-Baseline laboratory tests (within 1 week prior to randomisation normally):
Neutrophils =1.5 x109/l and platelet count =100 x109/l
Alkaline phosphatase =5 x upper limit of normal (ULN), Serum bilirubin =1.25 x ULN, and serum transaminase (either AST or ALT) =2.5 x ULN
Estimated creatinine clearance =30ml/min or measured GFR (EDTA clearance) =30 ml/min
8.For women of childbearing potential, negative pregnancy test and adequate contraceptive precautions
9.Effective contraception for male patients if the risk of conception exists
10.Written informed consent including consent to the immediate release of tumour blocks for analysis of molecular markers
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
1.Patients expected to be suitable for surgical resection of metastatic disease after response to chemotherapy as decided by MDT. (These patients should be considered for the New-EPOC trial)
2.No 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.:
-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.
-History of severe peptic ulcer disease
-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.
-Nephrotic Syndrome
-Known coagulopathy
-Patients requiring ongoing therapy with ciclosporin-A (due to interaction with irinotecan)
6.Patients requiring ongoing treatment with a contraindicated concomitant medication
7.Patients with another previous or current malignant disease which, in the judgement of the treating investigator, is likely to interfere with FOCUS 3 treatment or assessment of response
8.Patients with known hypersensitivity reactions to any of the components of the study treatments
9.Patients with brain metastases
10.Patients with a personal or family history suggestive of DPD deficiency or with known DPD deficiency
11.History of uncontrolled seizures, central nervous system disorders or psychiatric disability judged by the investigator to be clinically significant precluding informed consent
12.History of surgery <4weeks prior to commencement of cycle 1
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method