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| NB: The information displayed below does not replace the protocol. The latest protocol version should always be consulted before making clinical decisions. |
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OE05
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A randomised controlled trial comparing standard chemotherapy followed by resection versus ECX chemotherapy followed by resection in patients with resectable adenocarcinoma of the oesophagus
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Topic
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Cancer
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Portfolio Eligibility
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Funded by UKCRC partner
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ISRCTN
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01852072
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EudraCT
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2004-000241-37
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MREC N° |
04/6/05
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UKCRN ID |
854
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WHO ID
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Study Type |
Interventional
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Design Type |
Treatment
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Disease(s) |
Oesophagus
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Phase |
III
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Current Status
| Open |
| Closure Date | 31/03/2010 |
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Sample Size
| 1300 |
| Accrual to Date |
 50% |
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Geographical Scope
| UK Multi-Centre |
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Lead Country
| England (also active in Scotland and Wales) |
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Open to new sites
| Yes, within and outside lead country |
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Main Inclusion Criteria
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1. Histologically verified adenocarcinoma of the oesophagus or type 1 and type 2 adenocarcinoma of the oesophago-gastric junction [17].
2. Adenocarcinoma as above, which includes disease staged as T1 N1, T2 N1, T3 N0, and T3 N1 as assessed by spiral CT and endoscopic ultrasound (EUS). Also T4 tumours that
(i) involve only the diaphragm or crura OR
(ii) invade only the mediastinal pleura.
3. Tumours with nodal disease (N1) affecting the origin of the left gastric and splenic artery with the coeliac axis (hitherto staged as M1a) can be included.
4. WHO performance status 0 or 1 (Appendix I).
5. Proven respiratory and cardiac function, to the following levels: FEV1 >1.5 litres; cardiac ejection fraction >50% on echocardiography or MUGA. These assessments must be performed within 4 weeks prior to randomisation.
6. Proven hepatic, renal and haematological function to the following levels: liver function tests not more than 1.5 x normal; glomerular filtration rate ?60ml/minute; white blood
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Main Exclusion Criteria
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1. Uncontrolled angina pectoris, myocardial infarction within 6 months, heart failure, clinically significant uncontrolled cardiac arrhythmias, or any patient with a clinically significant abnormal ECG. Patients with abnormal left ventricular ejection fraction (LVEF) determined on MUGA scan or echocardiography, including areas of abnormal contractility, should also be excluded.
2. Oesophageal tumours staged as T1 N0 and stage T2 N0.
3. Patients with any previous treatment for oesophageal carcinoma.
4. Type 3 oesophago-gastric tumours. Lower limit of endoscopically visible primary tumour should not involve stomach for more than 2cm and no evidence of full thickness disease below the diaphragm on laparoscopy.
5. T4 tumours invading contiguous structures other than diaphragm, crura or mediastinal pleura.
6. Patients with disease in any of the following areas on the CT scan, EUS or other staging investigation:
a) Evidence of metastases in liver, lung, bone or other distant metastases.
b)
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Chief Investigator(s)
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| Prof Derek Alderson | Prof David Cunningham |
| Ms Sally Stenning |
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Further details, please contact
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Mr Paul Cortissos
Medical Research Council
222 Euston Road
London
NW1 2DA
UNITED KINGDOM
Tel: 0207 6704795
Fax: 0207 670 4949
pbc@ctu.mrc.ac.uk
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Funder(s) |
Cancer Research UK
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Sponsor(s) |
Medical Research Council
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