FOCUS 2: Drug treatment for bowel cancer - making the best choices when a milder treatment is needed

• Register: ISRCTN
• Last refreshed on: 12 November 2018
• Main ID: ISRCTN21221452
• Date of registration: 02/11/2005
• Prospective Registration: No
• Primary sponsor: Medical Research Council (UK)
• Public title: FOCUS 2: Drug treatment for bowel cancer - making the best choices when a milder treatment is needed
• Scientific title: FOCUS 2: Drug treatment for bowel cancer - making the best choices when a milder treatment is needed
• Date of first enrolment: 29/01/2004
• Target sample size: 460
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN21221452
• Study type: Interventional
• Study design: Randomised controlled trial (Treatment)
• Phase: Not Applicable

Countries of recruitment

United Kingdom

Contacts

• Name: Matthew Seymour

Key inclusion & exclusion criteria

Inclusion criteria: 1. Confirmed colorectal adenocarcinoma: Either previous or current histologically confirmed primary adenocarcinoma of colon or rectum & clinical/radiological evidence of advanced/metastatic disease or histologically/cytologically confirmed metastatic adenocarcinoma, with clinical/radiological evidence of colorectal primary tumour
2. Unidimensionally measurable disease (Response Evaluation Criteria in Solid Tumors [RECIST] criteria)
3. No previous systemic palliative chemotherapy for metastatic disease. (Adjuvant chemotherapy with 5-fluorouracil (5FU) +/- folinic acid (FA) allowed if completed >4 months prior to trial entry. Rectal chemoradiotherapy with 5FU +/- FA allowed if completed >1 month prior to trial entry.)
4. WHO performance status 0, 1 or 2
5. Baseline laboratory tests (within 1 week prior to randomisation): white blood cell count (WBC) >3 x 10^9/l and platelet count >100 x 10^9/l, serum bilirubin =3 x upper limit of normal (ULN), and serum transaminase (either aspartate aminotransferase [AST] or alanine aminotransferase [ALT]) =2.5 x ULN either estimated creatinine clearance >50 ml/min or measured glomerular filtration rate (GFR) (ethylene diamine tetraacetic acid [EDTA] clearance) >30 ml/min. Patients with GFR of 30-49 ml/min, if allocated oxaliplatin and/or capecitabine receive 25% reduced dose.
6. For women: negative pregnancy test and adequate contraceptive precautions
7. Informed Consent
Exclusion criteria: 1. Patients who are fit and suitable for full-dose combination chemotherapy e.g. suitable and willing to be entered into the main FOCUS trial or equivalent; eligible and suitable for 1st-line combination as per NICE guidance
2. Patients who are unfit for the reduced-dose treatments in this protocol e.g. severe uncontrolled concurrent medical illness (including poorly-controlled angina or very recent myocardial infarction [MI]) likely to interfere with protocol treatments; any psychiatric or neurological condition which is felt likely to compromise the patient's ability to give informed consent or to comply with oral edication; partial or complete bowel obstruction; pre-existing neuropathy (>grade 1)
3. Patients requiring ongoing treatment with a contraindicated concomitant medication
4. Patients with another previous or current malignant disease which, in the judgement of the treating consultant, is likely to interfere with FOCUS2 treatment or assessment of response

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Advanced Colorectal Cancer
Cancer
Colorectal

Intervention(s)

Plan D: MdG (80% Standard Treatment) for 12 weeks, usually 6 cycles. 14 day cycle where drug is only given on days 1 and 2. At 6-week review (cycle 4), a dose increase to full dose may be considered at the clinician's discretion. At approximately 14 weeks a clinical/radiological review should be done to determine if the outcome of treatment has been 'Treatment benefit' or 'No treatment benefit'. Patients with 'No treatment benefit' may be considered for second-line therapy. If they are considered suitable for second-line therapy they should then be given OxMdG 2nd-line.

Plan E: OxMdG (80% Standard Treatment) for 12 weeks, usually 6 cycles. 14 day cycle. At 6-week review (cycle 4), a dose increase to full dose may be considered at the clinician's discretion.

Plan F: Cap (80% Standard Treatment) for 12 weeks, usually 4 cycles. 21 day cycle. At 6-week review (cycle 3), a dose increase to full dose may be considered at the clinician's discretion. At approximately 14 weeks a clinical/radiological review should be done to determine if the outcome of treatment has been 'Treatment benefit' or 'No treatment benefit'. Patients with 'No treatment benefit' may be considered for second-line therapy. If they are considered suitable for second-line therapy they should then be given OxCap 2nd-line.

Plan G: OxCap (80% Standard Treatment) for 12 weeks, usually 4 cycles. 21 day cycle. At 6-week review (cycle 4), a dose increase to full dose may be considered at the clinician's discretion.

Primary Outcome(s)

The principal outcome measures are progression-free survival (for the oxaliplatin comparison) and QoL (for the FU/capecitabine comparison).

Secondary Outcome(s)

Secondary outcome measures (both randomisations) also include Limited Health Assessments (LHA), chemotherapy toxicity/adverse events, overall failure-free survival and overall survival. Baseline CHA will be correlated with outcome in each treatment arm to identify thresholds for treatment benefit. Cross-trial comparisons will be made with FOCUS, which shares two treatment arms.

Secondary ID(s)

CR09

NCT00070213

Source(s) of Monetary Support

Cancer Research UK (CRUK) Ref: C6003/A3830

Ethics review

Status:
Approval date:
Contact:

Not provided at time of registration.

Results

• Results available: Yes
• Date Completed: 31/01/2007