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

Completed

• Conditions: Colorectal cancer; Cancer; Colorectal

• Registration Number: ISRCTN82942120
• Lead Sponsor: Medical Research Council (MRC) (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2000-04-06
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 905

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 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Survival

Secondary Outcome Measures

Name	Time	Method
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