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Pre-operative Epirubicin, Capecitabine (Xeloda) and Cisplatin in Patients With Newly Diagnosed Localised Oesophageal Adenocarcinoma

Phase 2
18 Years
Not Enrolling
Adenocarcinoma of Oesophagus

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Trial Information

Pre-operative Epirubicin, Capecitabine (Xeloda) and Cisplatin in Patients With Newly Diagnosed Localised Oesophageal Adenocarcinoma

Inclusion Criteria:

- Age > 18 years.

- Histologically verified adenocarcinoma of the thoracic oesophagus or type 1, 2 and 3
tumours of the oesophagogastric junction (type 1 refers to lower oesophageal, type 2
refers to cardial and type 3 refers to subcardinal cancers).

- AJCC Stage II-III (T2-3 N0-1 M0) (28), as assessed by spiral or multi-slice CT and
endoscopic ultrasound, where primary surgery would be considered with curative

- No previous chemotherapy, radiotherapy or other investigational drug treatment for
this indication.

- WHO performance status 0,1 or 2.

- Adequate bone marrow function with platelets > 100 x 109/l; WBC > 3 x 109/l;
neutrophils > 1.5 x 109/l at the time of study entry.

- Serum bilirubin < 35 mol/l.

- Serum creatinine < 180 mol/l and measured creatinine clearance over 60ml/min.

- No concurrent uncontrolled medical condition.

- No previous malignant disease other than non-melanotic skin cancer or carcinoma in
situ of the uterine cervix in the last 10 years.

- Life expectancy > 3 months.

- Adequate contraceptive precautions if relevant.

- Informed written consent.

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:

- Evidence of liver, lung or other distant metastases

- Para-aortic/coeliac lymphadenopathy > 1cm diameter on CT, > 6mm diameter on EUS

- Invasion of airways, aorta, pericardium, or lung

- 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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Pathological complete response rate

Principal Investigator

David Cunningham

Investigator Role:

Principal Investigator

Investigator Affiliation:

Royal Marsden NHS Foundation Trust


United Kingdom: Medicines and Healthcare Products Regulatory Agency

Study ID:




Start Date:

November 2002

Completion Date:

Related Keywords:

  • Adenocarcinoma of Oesophagus
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous