Adenocarcinoma of Oesophagus Clinical Trial
Official title:
Pre-operative Epirubicin, Capecitabine (Xeloda) and Cisplatin in Patients With Newly Diagnosed Localised Oesophageal Adenocarcinoma
| NCT number | NCT00220103 |
| Other study ID # | 2185 |
| Secondary ID | |
| Status | Completed |
| Phase | Phase 2 |
| First received | September 19, 2005 |
| Last updated | December 15, 2009 |
| Start date | November 2002 |
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.
| Status | Completed |
| Enrollment | 80 |
| Est. completion date | |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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 intent. - 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. |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United Kingdom | Royal Marsden NHS Foundation Trust | Sutton | Surrey |
| Lead Sponsor | Collaborator |
|---|---|
| Royal Marsden NHS Foundation Trust |
United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Pathological complete response rate | |||
| Secondary | Progression free survival | |||
| Secondary | Overall survival | |||
| Secondary | Objective response rate assessed by CT and EUS | |||
| Secondary | Treatment related toxicity including peri-operative complications | |||
| Secondary | Time to improvement of dysphagia | |||
| Secondary | Pattern of treatment failure | |||
| Secondary | To assess the value of high resolution MRI to depict response to treatment and compare it with EUS and histopathology |