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To investigate the efficacy and safety of epirubicin, cisplatin and capecitabine as neoadjuvant therapy prior to radical resection in patients with newly diagnosed operable oesophageal adenocarcinoma.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| epirubicin, capecitabine, cisplatin | Drug | |||
| Surgical resection | Procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Pathological complete response rate |
| Measure | Description | Time Frame |
|---|---|---|
| Progression free survival | ||
| Overall survival | ||
| Objective response rate assessed by CT and EUS |
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Inclusion Criteria:
Exclusion Criteria:
The presence of locally advanced or metastatic disease precluding curative surgical resection (T4 or Stage IV or M1a-b)
Total dysphagia (O'Rourke's swallowing function scoring system 5) precluding swallowing of capecitabine even when crushed
Medical or psychiatric conditions that compromise the patient's ability to give informed consent.
Patients with disease in any of the following areas on the basis of CT scan and/or endoscopic ultrasound:
New York Heart Association classification Grade III or IV.
Uncontrolled angina pectoris.
Pregnancy or breast feeding.
Impaired renal function with measured creatinine clearance less than 60 ml/min.
Known malabsorption syndromes.
Patients with a known hypersensitivity to 5-FU or with a dihydropyrimidine dehydrogenase (DPD) deficiency.
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| Name | Affiliation | Role |
|---|---|---|
| David Cunningham | Royal Marsden NHS Foundation Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal Marsden NHS Foundation Trust | Sutton | Surrey | United Kingdom |
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| Treatment related toxicity including peri-operative complications |
| Time to improvement of dysphagia |
| Pattern of treatment failure |
| To assess the value of high resolution MRI to depict response to treatment and compare it with EUS and histopathology |
| ID | Term |
|---|---|
| C562730 | Adenocarcinoma Of Esophagus |
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| ID | Term |
|---|---|
| D015251 | Epirubicin |
| D000069287 | Capecitabine |
| D002945 | Cisplatin |
| ID | Term |
|---|---|
| D004317 | Doxorubicin |
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005472 | Fluorouracil |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
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