Neoadjuvant Epirubicin, Cisplatin and Capecitabine (Xeloda) [ECX] Followed by Definitive Chemoradiation With or Without Surgery for Patients With Newly Diagnosed Localized Squamous Cell Carcinoma of the Oesophagus
- Age > 18 years.
- Histologically verified squamous cell carcinoma of the cervical or thoracic
- American Joint Committee on Cancer (AJCC) Stage I-III (T1-3 N0-1 M0) (33), as
assessed by spiral or multi-slice computed tomography (CT) and endoscopic ultrasound,
where radical chemoradiation would be considered with curative intent.
- No previous chemotherapy, radiotherapy or other investigational drug treatment for
- World Health Organization (WHO) performance status 0,1 or 2.
- Adequate bone marrow function with platelets > 100 x 10^9/l; white blood cells (WBC)
> 3 x 10^9/l; neutrophils > 1.5 x 10^9/l at the time of study entry.
- Serum bilirubin < 35 micromol/l.
- Serum creatinine < 180 micromol/l and measured creatinine clearance over 60 ml/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.
- The presence of locally advanced or metastatic disease precluding curative
chemoradiation (T4 or Stage IV or M1a-b) or disease not encompassable in a radical
- 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
- Intracerebral metastases or meningeal carcinomatosis.
- 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.
- Previous investigational study drug
- Known malabsorption syndromes
- Patients with a known hypersensitivity to fluorouracil (5-FU) or with a
dihydropyrimidine dehydrogenase (DPD) deficiency
- Hearing loss