Status:
COMPLETED
Neoadjuvant Epirubicin, Cisplatin and Capecitabine (ECX) Followed by Definitive Chemoradiation With/Without Surgery for Squamous Cell Carcinoma of the Oesophagus
Lead Sponsor:
Royal Marsden NHS Foundation Trust
Conditions:
Oesophageal Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 rad...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT00220129
Start Date
November 1 2002
Last Update
December 16 2009
Active Locations (1)
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1
Royal Marsden Hospital
Sutton, Surrey, United Kingdom, SM2 5PT