Colorectal cancer Cancer Malignant neoplasm of other and ill defined digestive organs
Conditions
Interventions
This is a five-arm trial in which patients will be randomly allocated to one of five 'treatment plans'. These plans comprise first-line and, in some cases, a second-line chemotherapy treatment plan. T
Sponsors
Medical Research Council (MRC) Clinical Trials Unit (UK)
Eligibility
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Survival from randomisation | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Time to failure of first-line treatment 2. Time to failure of protocol treatment plan 3. Objective response rate 4. Patient assessment of quality of life and acceptability of treatment, health economics | — |
Countries
United Kingdom
Outcome results
None listed