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 个研究点目标入组 905 人开始时间: 2000年4月6日最近更新: 2015年1月13日

适应症

试验速览

暂无简介。

•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

发起方

Medical Research Council (MRC) (UK)