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

This study has been completed.
Sponsor:
Information provided by:
Royal Marsden NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT00220103
First received: September 19, 2005
Last updated: December 15, 2009
Last verified: December 2009
History of Changes
  Purpose

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 Intervention Phase
Adenocarcinoma of Oesophagus
 Drug: epirubicin, capecitabine, cisplatin
Procedure: Surgical resection
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pre-operative Epirubicin, Capecitabine (Xeloda) and Cisplatin in Patients With Newly Diagnosed Localised Oesophageal Adenocarcinoma

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Royal Marsden NHS Foundation Trust:

Primary Outcome Measures:
  • Pathological complete response rate

Secondary Outcome Measures:
  • 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
  • Pattern of treatment failure
  • To assess the value of high resolution MRI to depict response to treatment and compare it with EUS and histopathology

Estimated Enrollment: 80
Study Start Date: November 2002
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00220103

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

No publications provided

Responsible Party: Jane Lawrence, Royal Marsden NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT00220103     History of Changes
Other Study ID Numbers: 2185
Study First Received: September 19, 2005
Last Updated: December 15, 2009
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Adenocarcinoma
Adenocarcinoma, Mucinous
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Cystic, Mucinous, and Serous
Capecitabine
Cisplatin
Epirubicin
 Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antibiotics, Antineoplastic
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 23, 2013