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

NCT00220103 | Completed Phase 2

• 1 other identifier: 2185
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Pathological complete response rate

Secondary Outcomes (7)

• Progression free survival

• Overall survival

• Objective response rate assessed by CT and EUS

• Treatment related toxicity including peri-operative complications

• Time to improvement of dysphagia

Interventions

epirubicin, capecitabine, cisplatin DRUG

Surgical resection PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Royal Marsden NHS Foundation Trust: lead

Study Sites (1)

Royal Marsden NHS Foundation Trust

Sutton, Surrey, United Kingdom

Location

MeSH Terms

Conditions

Adenocarcinoma Of Esophagus

Interventions

Epirubicin; Capecitabine; Cisplatin

Intervention Hierarchy (Ancestors)

Doxorubicin; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• David Cunningham

  Royal Marsden NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 19, 2005
• First Posted: September 22, 2005
• Study Start: November 1, 2002
• Last Updated: December 16, 2009

Record last verified: 2009-12

Locations

GB (1)