- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00220129
Neoadjuvant Epirubicin, Cisplatin and Capecitabine (ECX) Followed by Definitive Chemoradiation With/Without Surgery for Squamous Cell Carcinoma of the Oesophagus
December 15, 2009 updated by: Royal Marsden NHS Foundation Trust
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
16
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
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Surrey
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Sutton, Surrey, United Kingdom, SM2 5PT
- Royal Marsden Hospital
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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 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
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 |
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2 year overall survival
|
Secondary Outcome Measures
Outcome Measure |
---|
Progression free survival
|
Treatment related toxicity
|
Time to improvement of dysphagia
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Pattern of treatment failure
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Objective clinical response rate assessed by computed tomography (CT), endoscopic ultrasound (EUS) and endoscopic biopsy
|
Proportion of patients not achieving clinical complete response and requiring surgery after chemoradiation
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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
- Digestive System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Head and Neck Neoplasms
- Esophageal Diseases
- Neoplasms, Squamous Cell
- Carcinoma
- Carcinoma, Squamous Cell
- Esophageal Neoplasms
- Esophageal Squamous Cell Carcinoma
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Topoisomerase II Inhibitors
- Topoisomerase Inhibitors
- Antibiotics, Antineoplastic
- Capecitabine
- Epirubicin
Other Study ID Numbers
- 2186
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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