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
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- 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
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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. |
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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
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Recruiting |
80 |
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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:
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Both |
18 Years and older |
No |
Contact: David Cunningham |
0208 661 3156 |
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United Kingdom |
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NCT00220103 |
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Royal Marsden NHS Foundation Trust |
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Principal Investigator: |
David Cunningham |
Royal Marsden NHS Foundation Trust |
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Royal Marsden NHS Foundation Trust |
September 2005 |