Colorectal cancer Cancer Colorectal
Conditions
Interventions
Patients with advanced colorectal cancer are randomised between three groups:
1. De Gramont bolus and infusion 5FU and folinic acid regimen
2. Lokich continuous infusion 5FU regimen
3. 'Tomudex' iv b
Sponsors
Medical Research Council (MRC) (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: First randomisation inclusion: 1. Histologically confirmed adenocarcinoma of the colon or rectum 2. Patients with either: locally advanced disease at presentation suitable only for palliative chemotherapy; metastatic disease at presentation suitable only for palliative chemotherapy; recurrent locally advanced or metastatic disease, now only suitable for palliative chemotherapy. If systemic chemotherapy was given previously this must have been 5-Flurouracil (5FU) based adjuvant therapy (eg QUASAR) and completed more than six months prior to trial entry. Disease not limited to a previously irradiated area. 3. Objectively or subjectively evaluable disease 4. Adequate bone marrow function 5. Adequate renal function with serum creatinine 1.25 x upper limit of normal and creatinine clearance more than 65 ml if serum creatinine exceeds upper limit of normal 6. World Health Organisation (WHO) performance status of 0 - 2, with life expectancy more than three months 7. Patient able and willing to complete QoL questionnaires Second randomisation: All patients in the trial should be randomised to stop or continue chemotherapy after 12 weeks (see 'Exclusions' below for exceptions)
Exclusion criteria
Exclusion criteria: Exclusion for second randomisation: 1. Patients with progressive disease on clinical or radiological evidence (more than a 25% increase in size of an existing lesion, or new lesions), or death 2. Patients who have stopped chemotherapy because of toxicity 3. Patient choice
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Quality of life, palliation of symptoms, toxicity, psychological impact, functional status, social functioning, global quality of life, subsidiary response rate health economics acceptability of treatment to patients | — |
Countries
United Kingdom
Outcome results
None listed