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

Primary Purpose

Adenocarcinoma of Oesophagus

Status
Completed
Phase
Phase 2
Locations
United Kingdom
Study Type
Interventional
Intervention
epirubicin, capecitabine, cisplatin
Surgical resection
Sponsored by
Royal Marsden NHS Foundation Trust
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adenocarcinoma of Oesophagus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Royal Marsden NHS Foundation Trust

Outcomes

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

Full Information

First Posted
September 19, 2005
Last Updated
December 15, 2009
Sponsor
Royal Marsden NHS Foundation Trust
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1. Study Identification

Unique Protocol Identification Number
NCT00220103
Brief Title
Pre-operative Epirubicin, Cisplatin, and Capecitabine in Patients With Newly Diagnosed Localised Oesophageal Adenocarcinoma
Official Title
Pre-operative Epirubicin, Capecitabine (Xeloda) and Cisplatin in Patients With Newly Diagnosed Localised Oesophageal Adenocarcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
December 2009
Overall Recruitment Status
Completed
Study Start Date
November 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Royal Marsden NHS Foundation Trust

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adenocarcinoma of Oesophagus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
epirubicin, capecitabine, cisplatin
Intervention Type
Procedure
Intervention Name(s)
Surgical resection
Primary Outcome Measure Information:
Title
Pathological complete response rate
Secondary Outcome Measure Information:
Title
Progression free survival
Title
Overall survival
Title
Objective response rate assessed by CT and EUS
Title
Treatment related toxicity including peri-operative complications
Title
Time to improvement of dysphagia
Title
Pattern of treatment failure
Title
To assess the value of high resolution MRI to depict response to treatment and compare it with EUS and histopathology

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Cunningham
Organizational Affiliation
Royal Marsden NHS Foundation Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royal Marsden NHS Foundation Trust
City
Sutton
State/Province
Surrey
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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

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