Pre-operative Epirubicin, Cisplatin, and Capecitabine in Patients With Newly Diagnosed Localised Oesophageal Adenocarcinoma

NCT ID: NCT00220103

Last Updated: 2009-12-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-11-30

Brief Summary

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.

Conditions

Adenocarcinoma of Oesophagus

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

epirubicin, capecitabine, cisplatin

Intervention Type: DRUG

Surgical resection

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Royal Marsden NHS Foundation Trust

OTHER

Sponsor Role: lead

Responsible Party

Royal Marsden NHS Foundation Trust

Principal Investigators

David Cunningham

Role: PRINCIPAL_INVESTIGATOR

Royal Marsden NHS Foundation Trust

Locations

Royal Marsden NHS Foundation Trust

Sutton, Surrey, United Kingdom

Countries

United Kingdom

Other Identifiers

2185

Identifier Type: -

Identifier Source: org_study_id