Oesophageal Carcinoma
Conditions
Brief summary
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.
Interventions
PROCEDURESurgical Resection
Sponsors
Royal Marsden NHS Foundation Trust
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 2 year overall survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Pattern of treatment failure | — |
| Progression free survival | — |
| Objective clinical response rate assessed by computed tomography (CT), endoscopic ultrasound (EUS) and endoscopic biopsy | — |
| Treatment related toxicity | — |
| Time to improvement of dysphagia | — |
| Proportion of patients not achieving clinical complete response and requiring surgery after chemoradiation | — |
Countries
United Kingdom
Outcome results
None listed