Ignite Creation Date:
2025-12-24 @ 7:24 PM
Ignite Modification Date:
2025-12-25 @ 5:04 PM
Study NCT ID:
NCT00220103
Status:
COMPLETED
Last Update Posted:
2009-12-16
First Post:
2005-09-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pre-operative Epirubicin, Cisplatin, and Capecitabine in Patients With Newly Diagnosed Localised Oesophageal Adenocarcinoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'C562730', 'term': 'Adenocarcinoma Of Esophagus'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015251', 'term': 'Epirubicin'}, {'id': 'D000069287', 'term': 'Capecitabine'}, {'id': 'D002945', 'term': 'Cisplatin'}], 'ancestors': [{'id': 'D004317', 'term': 'Doxorubicin'}, {'id': 'D003630', 'term': 'Daunorubicin'}, {'id': 'D018943', 'term': 'Anthracyclines'}, {'id': 'D009279', 'term': 'Naphthacenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D000617', 'term': 'Aminoglycosides'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D005472', 'term': 'Fluorouracil'}, {'id': 'D014498', 'term': 'Uracil'}, {'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D003853', 'term': 'Deoxyribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D017671', 'term': 'Platinum Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-12', 'lastUpdateSubmitDate': '2009-12-15', 'studyFirstSubmitDate': '2005-09-19', 'studyFirstSubmitQcDate': '2005-09-19', 'lastUpdatePostDateStruct': {'date': '2009-12-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-22', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pathological complete response rate'}], 'secondaryOutcomes': [{'measure': 'Progression free survival'}, {'measure': 'Overall survival'}, {'measure': 'Objective response rate assessed by CT and EUS'}, {'measure': 'Treatment related toxicity including peri-operative complications'}, {'measure': 'Time to improvement of dysphagia'}, {'measure': 'Pattern of treatment failure'}, {'measure': 'To assess the value of high resolution MRI to depict response to treatment and compare it with EUS and histopathology'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Adenocarcinoma of Oesophagus']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age \\> 18 years.\n* 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).\n* 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.\n* No previous chemotherapy, radiotherapy or other investigational drug treatment for this indication.\n* WHO performance status 0,1 or 2.\n* 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.\n* Serum bilirubin \\< 35 mol/l.\n* Serum creatinine \\< 180 mol/l and measured creatinine clearance over 60ml/min.\n* No concurrent uncontrolled medical condition.\n* No previous malignant disease other than non-melanotic skin cancer or carcinoma in situ of the uterine cervix in the last 10 years.\n* Life expectancy \\> 3 months.\n* Adequate contraceptive precautions if relevant.\n* Informed written consent.\n\nExclusion Criteria:\n\n* The presence of locally advanced or metastatic disease precluding curative surgical resection (T4 or Stage IV or M1a-b)\n* Total dysphagia (O'Rourke's swallowing function scoring system 5) precluding swallowing of capecitabine even when crushed\n* Medical or psychiatric conditions that compromise the patient's ability to give informed consent.\n* Patients with disease in any of the following areas on the basis of CT scan and/or endoscopic ultrasound:\n\n * Evidence of liver, lung or other distant metastases\n * Para-aortic/coeliac lymphadenopathy \\> 1cm diameter on CT, \\> 6mm diameter on EUS\n * Invasion of airways, aorta, pericardium, or lung\n* New York Heart Association classification Grade III or IV.\n* Uncontrolled angina pectoris.\n* Pregnancy or breast feeding.\n* Impaired renal function with measured creatinine clearance less than 60 ml/min.\n* Known malabsorption syndromes.\n* Patients with a known hypersensitivity to 5-FU or with a dihydropyrimidine dehydrogenase (DPD) deficiency."}, 'identificationModule': {'nctId': 'NCT00220103', 'briefTitle': 'Pre-operative Epirubicin, Cisplatin, and Capecitabine in Patients With Newly Diagnosed Localised Oesophageal Adenocarcinoma', 'organization': {'class': 'OTHER', 'fullName': 'Royal Marsden NHS Foundation Trust'}, 'officialTitle': 'Pre-operative Epirubicin, Capecitabine (Xeloda) and Cisplatin in Patients With Newly Diagnosed Localised Oesophageal Adenocarcinoma', 'orgStudyIdInfo': {'id': '2185'}}, 'armsInterventionsModule': {'interventions': [{'name': 'epirubicin, capecitabine, cisplatin', 'type': 'DRUG'}, {'name': 'Surgical resection', 'type': 'PROCEDURE'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Sutton', 'state': 'Surrey', 'country': 'United Kingdom', 'facility': 'Royal Marsden NHS Foundation Trust', 'geoPoint': {'lat': 51.35, 'lon': -0.2}}], 'overallOfficials': [{'name': 'David Cunningham', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Royal Marsden NHS Foundation Trust'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Royal Marsden NHS Foundation Trust', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Jane Lawrence', 'oldOrganization': 'Royal Marsden NHS Foundation Trust'}}}}