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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00220103
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : December 16, 2009
Information provided by:
Royal Marsden NHS Foundation Trust

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.

Condition or disease Intervention/treatment Phase
Adenocarcinoma of Oesophagus Drug: epirubicin, capecitabine, cisplatin Procedure: Surgical resection Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pre-operative Epirubicin, Capecitabine (Xeloda) and Cisplatin in Patients With Newly Diagnosed Localised Oesophageal Adenocarcinoma
Study Start Date : November 2002

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Pathological complete response rate

Secondary Outcome Measures :
  1. Progression free survival
  2. Overall survival
  3. Objective response rate assessed by CT and EUS
  4. Treatment related toxicity including peri-operative complications
  5. Time to improvement of dysphagia
  6. Pattern of treatment failure
  7. To assess the value of high resolution MRI to depict response to treatment and compare it with EUS and histopathology

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00220103

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United Kingdom
Royal Marsden NHS Foundation Trust
Sutton, Surrey, United Kingdom
Sponsors and Collaborators
Royal Marsden NHS Foundation Trust
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Principal Investigator: David Cunningham Royal Marsden NHS Foundation Trust

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Responsible Party: Jane Lawrence, Royal Marsden NHS Foundation Trust Identifier: NCT00220103     History of Changes
Other Study ID Numbers: 2185
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: December 16, 2009
Last Verified: December 2009
Additional relevant MeSH terms:
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Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Antineoplastic Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors