Chemotherapy choices in advanced colorectal cancer - a randomised trial comparing two durations and three chemotherapy regimens in the palliative treatment of advanced colorectal cancer

Medical Research Council (MRC) (UK)0 sites905 target enrollmentApril 6, 2000

Overview

No summary available.

Registry

who.int

Start Date

April 6, 2000

End Date

TBD

Last Updated

11 years ago

Study Type

Interventional

Sex

All

Sponsor

Medical Research Council (MRC) (UK)

•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 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