Neoadjuvant Epirubicin, Cisplatin and Capecitabine (ECX) Followed by Definitive Chemoradiation With/Without Surgery for Squamous Cell Carcinoma of the Oesophagus

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: NCT00220129
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : December 16, 2009
Information provided by:
Royal Marsden NHS Foundation Trust

Brief Summary:
This is a study to investigate the efficacy and safety of epirubicin, cisplatin and capecitabine (ECX) as neoadjuvant therapy prior to radical chemoradiotherapy using capecitabine and cisplatin as radio-sensitisers in patients with newly diagnosed localized squamous cell carcinoma of the oesophagus.

Condition or disease Intervention/treatment Phase
Oesophageal Carcinoma Drug: Epirubicin, Cisplatin, Capecitabine Procedure: Surgical Resection Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Neoadjuvant Epirubicin, Cisplatin and Capecitabine (Xeloda) [ECX] Followed by Definitive Chemoradiation With or Without Surgery for Patients With Newly Diagnosed Localized Squamous Cell Carcinoma of the Oesophagus
Study Start Date : November 2002

Primary Outcome Measures :
  1. 2 year overall survival

Secondary Outcome Measures :
  1. Objective clinical response rate assessed by computed tomography (CT), endoscopic ultrasound (EUS) and endoscopic biopsy
  2. Pattern of treatment failure
  3. Progression free survival
  4. Proportion of patients not achieving clinical complete response and requiring surgery after chemoradiation
  5. Treatment related toxicity
  6. Time to improvement of dysphagia

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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 squamous cell carcinoma of the cervical or thoracic oesophagus
  • American Joint Committee on Cancer (AJCC) Stage I-III (T1-3 N0-1 M0) (33), as assessed by spiral or multi-slice computed tomography (CT) and endoscopic ultrasound, where radical chemoradiation would be considered with curative intent.
  • No previous chemotherapy, radiotherapy or other investigational drug treatment for this indication.
  • World Health Organization (WHO) performance status 0,1 or 2.
  • Adequate bone marrow function with platelets > 100 x 10^9/l; white blood cells (WBC) > 3 x 10^9/l; neutrophils > 1.5 x 10^9/l at the time of study entry.
  • Serum bilirubin < 35 micromol/l.
  • Serum creatinine < 180 micromol/l and measured creatinine clearance over 60 ml/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 chemoradiation (T4 or Stage IV or M1a-b) or disease not encompassable in a radical radiotherapy field.
  • 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.
  • Intracerebral metastases or meningeal carcinomatosis.
  • 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.
  • Previous investigational study drug
  • Known malabsorption syndromes
  • Patients with a known hypersensitivity to fluorouracil (5-FU) or with a dihydropyrimidine dehydrogenase (DPD) deficiency
  • Hearing loss

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): NCT00220129

United Kingdom
Royal Marsden Hospital
Sutton, Surrey, United Kingdom, SM2 5PT
Sponsors and Collaborators
Royal Marsden NHS Foundation Trust
Principal Investigator: David Cunningham Royal Marsden NHS Foundation Trust

Responsible Party: Jane Lawrence, Royal Marsden NHS Foundation Trust Identifier: NCT00220129     History of Changes
Other Study ID Numbers: 2186
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: December 16, 2009
Last Verified: December 2009

Additional relevant MeSH terms:
Carcinoma, Squamous Cell
Esophageal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Squamous Cell
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Antineoplastic Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors