Pre-operative chemotherapy for cancer of the oesophagus
| ISRCTN | ISRCTN43987580 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN43987580 |
| Protocol serial number | OE02 |
| Sponsor | Medical Research Council (MRC) (UK) |
| Funder | Medical Research Council (MRC) (UK) |
- Submission date
- 28/02/2001
- Registration date
- 28/02/2001
- Last edited
- 22/02/2010
- 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 James Lyddiard
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 | To investigate in patients considered to have resectable cancer of the oesophagus whether pre-operative chemotherapy: 1. Prolongs survival 2. Affects physical well-being |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Cancer |
| Intervention | 1. One group receives pre-operative chemotherapy followed by surgery 2. The other group = Control group receives surgery alone |
| Intervention type | Other |
| Primary outcome measure(s) |
Survival time |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 30/06/1998 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 800 |
| Key inclusion criteria | 1. Tumour considered resectable 2. No evidence of cervical lymph node involvement or metastases 3. Creatinine clearance ≥60 ml/min 4. Total white blood cell count ≥3.5 x 109l 5. Platelet count ≥100 x 109l 6. No indication for urgent resection 7. No previous chemotherapy, radiotherapy or surgery for current oesophageal cancer 8. No other previous or concomitant malignant disease |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/02/1992 |
| Date of final enrolment | 30/06/1998 |
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 | long term results | 20/10/2009 | Yes | No |
