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Pre-Operative Epirubicin, Cisplatin, and Capecitabine in Patients With Newly Diagnosed Localised Oesophageal Adenocarcinoma
This study is currently recruiting participants.
Study NCT00220103   Information provided by Royal Marsden NHS Foundation Trust
First Received: September 19, 2005   Last Updated: May 30, 2008   History of Changes
This Tabular View shows the required WHO registration data elements as marked by

September 19, 2005
May 30, 2008
November 2002
Pathological complete response rate
Same as current
Complete list of historical versions of study NCT00220103 on ClinicalTrials.gov Archive Site
  • 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
  • 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
 
Pre-Operative Epirubicin, Cisplatin, and Capecitabine in Patients With Newly Diagnosed Localised Oesophageal Adenocarcinoma
Pre-Operative Epirubicin, Capecitabine (Xeloda) and Cisplatin in Patients With Newly Diagnosed Localised Oesophageal Adenocarcinoma

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.

 
Phase II
Interventional
Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Adenocarcinoma of Oesophagus
  • Drug: epirubicin, capecitabine, cisplatin
  • Procedure: Surgical resection
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
80
 
 

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.
Both
18 Years and older
No
Contact: David Cunningham 0208 661 3156
United Kingdom
 
 
NCT00220103
 
 
Royal Marsden NHS Foundation Trust
 
Principal Investigator: David Cunningham Royal Marsden NHS Foundation Trust
Royal Marsden NHS Foundation Trust
September 2005

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.