Oesophageal Carcinoma Clinical Trial
Official title:
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
NCT number | NCT00220129 |
Other study ID # | 2186 |
Secondary ID | |
Status | Completed |
Phase | Phase 2 |
First received | September 19, 2005 |
Last updated | December 15, 2009 |
Start date | November 2002 |
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.
Status | Completed |
Enrollment | 16 |
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 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 |
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 Hospital | Sutton | Surrey |
Lead Sponsor | Collaborator |
---|---|
Royal Marsden NHS Foundation Trust |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 2 year overall survival | |||
Secondary | Objective clinical response rate assessed by computed tomography (CT), endoscopic ultrasound (EUS) and endoscopic biopsy | |||
Secondary | Pattern of treatment failure | |||
Secondary | Progression free survival | |||
Secondary | Proportion of patients not achieving clinical complete response and requiring surgery after chemoradiation | |||
Secondary | Treatment related toxicity | |||
Secondary | Time to improvement of dysphagia |
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