Chemotherapy choices in advanced colorectal cancer - a randomised trial comparing two durations and three chemotherapy regimens in the palliative treatment of advanced colorectal cancer
| ISRCTN | ISRCTN82942120 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN82942120 |
| Protocol serial number | CR06 |
| Sponsor | Medical Research Council (MRC) (UK) |
| Funder | Medical Research Council (MRC) (UK) |
- Submission date
- 06/04/2000
- Registration date
- 06/04/2000
- Last edited
- 30/07/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Dionne Cain
Scientific
Scientific
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | This trial aims to address two questions in the palliative treatment of patients with advanced colorectal cancer, namely: 1. Are the three chemotherapy regimens equivalent in terms of survival, and if so are there differences in the levels of quality of life (QoL) experienced by the patients? 2. In patients with stable or responding disease at 12 weeks, is there a survival benefit if chemotherapy is continued indefinitely, compared to a policy of stopping chemotherapy at 12 weeks, and what are the quality of life implications? |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Colorectal cancer |
| Intervention | 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 bolus. After 12 weeks their status is reassessed and those patients with responding or stable disease are randomised to one of two groups: 1. STOP chemotherapy, retreating on progression if appropriate 2. CONTINUE chemotherapy, with 12-weekly review, until disease progression, or unacceptable toxicity |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | fluorouracil, leucovorin calcium, raltitrexed |
| Primary outcome measure(s) |
Survival |
| Key secondary outcome measure(s) |
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 |
| Completion date | 10/05/1999 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 905 |
| Key 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) |
| Key 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 |
| Date of first enrolment | 10/05/1996 |
| Date of final enrolment | 10/05/1999 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
MRC Clinical Trials Unit
London
NW1 2DA
United Kingdom
NW1 2DA
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 08/02/2003 | Yes | No |
