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

This study has been completed.

Sponsor:

Information provided by:

Royal Marsden NHS Foundation Trust

ClinicalTrials.gov Identifier:

NCT00220129

First received: September 19, 2005

Last updated: December 15, 2009

Last verified: December 2009

History of Changes

Tracking Information

First Received Date ^ICMJE

September 19, 2005

Last Updated Date

December 15, 2009

Start Date ^ICMJE

November 2002

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

2 year overall survival

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00220129 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Objective clinical response rate assessed by computed tomography (CT), endoscopic ultrasound (EUS) and endoscopic biopsy
Pattern of treatment failure
Progression free survival
Proportion of patients not achieving clinical complete response and requiring surgery after chemoradiation
Treatment related toxicity
Time to improvement of dysphagia

Original Secondary Outcome Measures ^ICMJE

Objective clinical response rate assessed by CT, EUS and endoscopic biopsy
Pattern of treatment failure
Progression free survival
Proportion of patients not achieving clinical complete response and require surgery after chemoradiation
Treatment related toxicity
Time to improvement of dysphagia

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Oesophageal Carcinoma

Intervention ^ICMJE

Drug: Epirubicin, Cisplatin, Capecitabine
Procedure: Surgical Resection

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

Not Provided

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United Kingdom

Administrative Information

NCT Number ^ICMJE

NCT00220129

Other Study ID Numbers ^ICMJE

2186

Has Data Monitoring Committee

Responsible Party

Jane Lawrence, Royal Marsden NHS Foundation Trust

Study Sponsor ^ICMJE

Royal Marsden NHS Foundation Trust

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

David Cunningham

Royal Marsden NHS Foundation Trust

Information Provided By

Royal Marsden NHS Foundation Trust

Verification Date

December 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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