Neoadjuvant Epirubicin, Cisplatin and Capecitabine (ECX) Followed by Definitive Chemoradiation With/Without Surgery for Squamous Cell Carcinoma of the Oesophagus

Study Overview
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Brief Summary
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This is a study to investigate the efficacy and safety of epirubicin, cisplatin and capecitabine (ECX) as neoadjuvant therapy prior to radical chemoradiotherapy using capecitabine and cisplatin as radio-sensitisers in patients with newly diagnosed localized squamous cell carcinoma of the oesophagus.

Official Title
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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

Conditions
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Oesophageal Carcinoma

Intervention / Treatment
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* Drug: Epirubicin, Cisplatin, Capecitabine
* Procedure: Surgical Resection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age > 18 years. Histologically verified squamous cell carcinoma of the cervical or thoracic oesophagus 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 this indication. 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. Exclusion Criteria: 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 radiotherapy field. 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. 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Epirubicin, Cisplatin, Capecitabine|nan|
|Procedure: Surgical Resection|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 2 year overall survival |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective clinical response rate assessed by computed tomography (CT), endoscopic ultrasound (EUS) and endoscopic biopsy |  |  | 
| Pattern of treatment failure |  |  | 
| Progression free survival |  |  | 
| Proportion of patients not achieving clinical complete response and requiring surgery after chemoradiation |  |  | 
| Treatment related toxicity |  |  | 
| Time to improvement of dysphagia |  |  |