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

December 15, 2009 updated by: Royal Marsden NHS Foundation Trust

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Surrey
      • Sutton, Surrey, United Kingdom
        • Royal Marsden NHS Foundation Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Pathological complete response rate

Secondary Outcome Measures

Outcome Measure
Overall survival
Progression free survival
Objective response rate assessed by CT and EUS
Treatment related toxicity including peri-operative complications
Time to improvement of dysphagia
Pattern of treatment failure
To assess the value of high resolution MRI to depict response to treatment and compare it with EUS and histopathology

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Royal Marsden NHS Foundation Trust

Investigators

  • Principal Investigator: David Cunningham, Royal Marsden NHS Foundation Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2002

Study Registration Dates

First Submitted

September 19, 2005

First Submitted That Met QC Criteria

September 19, 2005

First Posted (Estimate)

September 22, 2005

Study Record Updates

Last Update Posted (Estimate)

December 16, 2009

Last Update Submitted That Met QC Criteria

December 15, 2009

Last Verified

December 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2185

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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