Neoadjuvant Epirubicin, Cisplatin and Capecitabine (ECX) Followed by Definitive Chemoradiation With/Without Surgery for Squamous Cell Carcinoma of the Oesophagus
This study has been completed.
Information provided by:
Royal Marsden NHS Foundation Trust
First received: September 19, 2005
Last updated: December 15, 2009
Last verified: December 2009
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.
Drug: Epirubicin, Cisplatin, Capecitabine
Procedure: Surgical Resection
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||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
Primary Outcome Measures:
Secondary Outcome Measures:
- 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
| Study Start Date:
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00220129
|Royal Marsden Hospital
|Sutton, Surrey, United Kingdom, SM2 5PT |
Royal Marsden NHS Foundation Trust
||Royal Marsden NHS Foundation Trust
No publications provided
||Jane Lawrence, Royal Marsden NHS Foundation Trust
History of Changes
|Other Study ID Numbers:
|Study First Received:
||September 19, 2005
||December 15, 2009
||United Kingdom: Medicines and Healthcare Products Regulatory Agency
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on December 10, 2013
Carcinoma, Squamous Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Squamous Cell
Digestive System Diseases
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Physiological Effects of Drugs
Molecular Mechanisms of Pharmacological Action