A randomised controlled trial comparing standard chemotherapy followed by resection versus Epirubicin, Cisplatin and Xeloda (ECX) chemotherapy followed by resection in patients with resectable adenocarcinoma of the oesophagus
| ISRCTN | ISRCTN01852072 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN01852072 |
| ClinicalTrials.gov (NCT) | NCT00041262 |
| Protocol serial number | OE05 |
| Sponsor | Medical Research Council (MRC) (UK) |
| Funder | Cancer Research UK (CRUK) (UK) |
- Submission date
- 23/06/2004
- Registration date
- 03/08/2004
- Last edited
- 29/10/2021
- 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
Contact information
Prof Derek Alderson
Scientific
Scientific
University Dept of Surgery, Level 7
Bristol Royal Infirmary
Marlborough Street
Bristol
BS2 8HW
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled phase III trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | A randomised controlled trial comparing standard chemotherapy followed by resection versus Epirubicin, Cisplatin and Xeloda (ECX) chemotherapy followed by resection in patients with resectable adenocarcinoma of the oesophagus |
| Study objectives | Randomised controlled phase III trial to compare pre-operative Epirubicin, Cisplatin and Xeloda (ECX) chemotherapy to standard pre-operative chemotherapy, in patients with resectable adenocarcinoma of the oesophagus. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Resectable adenocarcinoma of the oesophagus or oesophago-gastric junction |
| Intervention | Patients with resectable adenocarcinoma of the oesophagus will be randomised to receive: 1. Pre-operative Epirubicin, Cisplatin and Xeloda (ECX) chemotherapy 2. Standard pre-operative chemotherapy |
| Intervention type | Drug |
| Phase | Phase III |
| Drug / device / biological / vaccine name(s) | Epirubicin, cisplatin, capecitabine, fluorouracil |
| Primary outcome measure(s) |
Not provided at time of registration |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/11/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 842 |
| Total final enrolment | 897 |
| Key inclusion criteria | 1. Histologically verified adenocarcinoma of the oesophagus or type 1 and type 2 adenocarcinoma of the oesophago-gastric junction 2. Adenocarcinoma as above, which includes disease staged as T1 N1, T2 N1, T3 N0, and T3 N1 as assessed by spiral computed tomography (CT) or endoscopic ultrasound. T4 tumours that involve only the diaphragm or crura as well as T4 tumours invading the mediastinal pleura only. 3. Tumours with nodal disease (N1) affecting the origin of the left gastric and splenic artery with the coeliac axis (hitherto staged as M1a) 4. World Health Organisation (WHO) performance status 0 or 1 5. Proven respiratory cardiac, hepatic, renal and haematological function to the following levels: forced expiratory volume in 1 second (FEV1) >1.5 litres; cardiac ejection fraction >50% of normal echocardiography; liver function tests not more than 1.5 x normal; glomerular filtration rate ≥60 ml/min; white blood cell count >3 x 10^9/l; platelets >100 x 10^9/l (from the time diagnosis of cancer was first suspected). 6. Written informed consent |
| Key exclusion criteria | Does not match inclusion criteria |
| Date of first enrolment | 01/11/2004 |
| Date of final enrolment | 01/11/2010 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Bristol Royal Infirmary
Bristol
BS2 8HW
United Kingdom
BS2 8HW
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | |
| IPD sharing plan | Not provided at time of registration |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/09/2017 | Yes | No | |
| Abstract results | results | 01/06/2015 | No | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Plain English results | 11/11/2015 | 29/10/2021 | No | Yes |
Editorial Notes
29/10/2021: The following changes have been made:
1. The Cancer Research UK lay results summary has been added.
2. The total final enrolment number has been added.
09/08/2017: Publication reference added.
08/02/2011: The overall trial end date was changed from 01/11/2010 to 01/04/2011 and the target number of participants was changed from 1300 to 842.
