Ignite Creation Date:
2025-12-24 @ 11:54 AM
Ignite Modification Date:
2025-12-31 @ 6:44 PM
Study NCT ID:
NCT00509561
Status:
UNKNOWN
Last Update Posted:
2012-12-18
First Post:
2007-07-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cisplatin, Capecitabine, and Radiation Therapy With or Without Cetuximab in Treating Patients With Esophageal Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004938', 'term': 'Esophageal Neoplasms'}, {'id': 'C562730', 'term': 'Adenocarcinoma Of Esophagus'}, {'id': 'D000077277', 'term': 'Esophageal Squamous Cell Carcinoma'}], 'ancestors': [{'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D002294', 'term': 'Carcinoma, Squamous Cell'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D018307', 'term': 'Neoplasms, Squamous Cell'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068818', 'term': 'Cetuximab'}, {'id': 'D000069287', 'term': 'Capecitabine'}, {'id': 'D002945', 'term': 'Cisplatin'}, {'id': 'D011878', 'term': 'Radiotherapy'}], 'ancestors': [{'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}, {'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'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 259}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2008-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-12', 'lastUpdateSubmitDate': '2012-12-17', 'studyFirstSubmitDate': '2007-07-30', 'studyFirstSubmitQcDate': '2007-07-30', 'lastUpdatePostDateStruct': {'date': '2012-12-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-07-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Treatment-failure rate at 24 weeks'}, {'measure': 'Overall survival'}], 'secondaryOutcomes': [{'measure': 'Feasibility'}, {'measure': 'Toxicity'}, {'measure': 'Quality of life'}, {'measure': 'Quality of assurance'}, {'measure': 'Health economics'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['adenocarcinoma of the esophagus', 'squamous cell carcinoma of the esophagus', 'stage IA esophageal cancer', 'stage IB esophageal cancer', 'stage IIA esophageal cancer', 'stage IIB esophageal cancer', 'stage IIIA esophageal cancer', 'stage IIIB esophageal cancer', 'stage IIIC esophageal cancer'], 'conditions': ['Esophageal Cancer']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Drugs used in chemotherapy, such as cisplatin and capecitabine, work in different ways to kill tumor cells or stop them from growing. Radiation therapy uses high-energy x-rays to kill tumor cells. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Cetuximab may also stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether giving cisplatin together with capecitabine and radiation therapy is more effective with or without cetuximab in treating esophageal cancer.\n\nPURPOSE: This randomized phase II/III trial is studying the side effects and how well giving cisplatin together with capecitabine, radiation therapy, and cetuximab works compared with giving cisplatin, capecitabine, and radiation therapy without cetuximab in treating patients with esophageal cancer.', 'detailedDescription': 'OBJECTIVES:\n\nPrimary\n\n* To determine whether the addition of cetuximab to definitive chemoradiotherapy comprising cisplatin, capecitabine, and radiotherapy shows evidence of enhanced overall survival in patients with carcinoma of the esophagus.\n* To determine the safety of this regimen in these patients.\n* To determine the feasibility of this regimen in these patients.\n\nOUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 treatment arms.\n\n* Arm I: Patients receive cisplatin IV over 2 hours on days 1, 22, 43, and 64 and oral capecitabine twice daily on days 1-84. Beginning in week 7 patients also undergo radiotherapy 5 days a week for 5 weeks (weeks 7-11). Treatment continues in the absence of disease progression or unacceptable toxicity.\n* Arm II: Patients receive cisplatin and capecitabine and undergo radiotherapy as in arm I. Patients also receive cetuximab IV over 1-2 hours on day 1 in weeks 1-12. Treatment continues in the absence of disease progression or unacceptable toxicity.\n\nQuality of life and health economics are assessed at baseline, during treatment, and at pre-specified time points during follow-up.\n\nAfter completion of study treatment, patients are followed every 3 months for 1 year, every 4 months for 1 year, and then annually for a minimum of 5 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "DISEASE CHARACTERISTICS:\n\n* Histologically confirmed carcinoma of the esophagus\n\n * Adenocarcinoma\n * Squamous cell\n * Undifferentiated carcinoma\n * Siewert type I tumor of the gastroesophageal junction\n* Localized, nonmetastatic disease (T1-4, N0-1) confirmed by endoscopic ultrasound (EUS) and spiral CT scan\n* Total disease length (primary and lymph nodes) \\< 10 cm by EUS\n* Not suitable for surgery (either for medical reasons or patient's choice)\n* No metastatic disease (i.e., M1a or M1b according to UICC TNM version 6)\n* No significant (\\> 2 cm) extension of tumor into the stomach\n\nPATIENT CHARACTERISTICS:\n\n* WHO performance status 0-1\n* Absolute neutrophil count ≥ 1,500/mm³\n* White blood cell count ≥ 2,000/mm³\n* Platelet count ≥ 100,000/mm³\n* Hemoglobin ≥ 10 g/dL (should be corrected to \\> 10 g/dL before treatment)\n* Serum bilirubin ≤ 1.5 times upper limit of normal (ULN)\n* ALT/AST ≤ 2.5 times ULN\n* Alkaline phosphatase ≤ 3 times ULN\n* Glomerular filtration rate \\> 40 mL/min OR \\> 60 mL/min estimated by Cockcroft-Gault formula\n* Adequate cardiac ejection fraction ≥ 40% by MUGA or ECHO\n* FEV\\_1 ≥ 1 L by spirometry\n* Not pregnant\n* Negative pregnancy test\n* Fertile patients must use effective contraception\n* No malignancy within the past 5 years\n* No unstable angina, uncontrolled hypertension, cardiac failure, or other clinically significant cardiac disease\n* No major trauma within the past 4 weeks\n* No known dihydropyrimidine dehydrogenase deficiency\n* No hearing impairment or sensory-motor neuropathy \\> grade 2\n\nPRIOR CONCURRENT THERAPY:\n\n* See Disease Characteristics\n* At least 4 weeks since prior sorivudine and analogues\n* At least 4 weeks since prior major surgery\n* At least 4 weeks since prior monoclonal antibody\n* At least 3 months since prior radiotherapy\n* No prior treatment for invasive esophageal carcinoma or gastroesophageal junction carcinoma (not including photodynamic therapy or laser therapy for high-grade dysplasia/carcinoma in situ)\n* No other prior treatment for this malignancy that would compromise the ability to deliver definitive mediastinal chemoradiotherapy or compromise survival"}, 'identificationModule': {'nctId': 'NCT00509561', 'briefTitle': 'Cisplatin, Capecitabine, and Radiation Therapy With or Without Cetuximab in Treating Patients With Esophageal Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Wales Cancer Trials Unit'}, 'officialTitle': 'A Randomised Phase II/III Multi-Centre Clinical Trial of Definitive Chemotherapy, With or Without Cetuximab, in Carcinoma of the Oesophagus', 'orgStudyIdInfo': {'id': 'CDR0000558804'}, 'secondaryIdInfos': [{'id': 'WCTU-SCOPE-1'}, {'id': 'EU-20739'}, {'id': 'EUDRACT-2006-002241-37'}, {'id': 'ISRCTN47718479'}, {'id': 'CTA-17853/0202/001-0001'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Chemo-radiotherapy', 'interventionNames': ['Drug: capecitabine', 'Drug: cisplatin', 'Radiation: radiation therapy']}, {'type': 'EXPERIMENTAL', 'label': 'Chemo-radiotherapy plus cetuximab', 'interventionNames': ['Biological: cetuximab', 'Drug: capecitabine', 'Drug: cisplatin', 'Radiation: radiation therapy']}], 'interventions': [{'name': 'cetuximab', 'type': 'BIOLOGICAL', 'armGroupLabels': ['Chemo-radiotherapy plus cetuximab']}, {'name': 'capecitabine', 'type': 'DRUG', 'armGroupLabels': ['Chemo-radiotherapy', 'Chemo-radiotherapy plus cetuximab']}, {'name': 'cisplatin', 'type': 'DRUG', 'armGroupLabels': ['Chemo-radiotherapy', 'Chemo-radiotherapy plus cetuximab']}, {'name': 'radiation therapy', 'type': 'RADIATION', 'armGroupLabels': ['Chemo-radiotherapy', 'Chemo-radiotherapy plus cetuximab']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'B12 2TH', 'city': 'Birmingham', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Queen Elizabeth Hospital at University Hospital of Birmingham NHS Trust', 'geoPoint': {'lat': 52.48142, 'lon': -1.89983}}, {'zip': 'B75 7RR', 'city': 'Birmingham', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Good Hope Hospital', 'geoPoint': {'lat': 52.48142, 'lon': -1.89983}}, {'zip': 'BN2 5BE', 'city': 'Brighton', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Sussex Cancer Centre at Royal Sussex County Hospital', 'geoPoint': {'lat': 50.82838, 'lon': -0.13947}}, {'zip': 'BS2 8ED', 'city': 'Bristol', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Bristol Haematology and Oncology Centre', 'geoPoint': {'lat': 51.45523, 'lon': -2.59665}}, {'zip': 'CB2 2QQ', 'city': 'Cambridge', 'state': 'England', 'country': 'United Kingdom', 'facility': "Addenbrooke's Hospital", 'geoPoint': {'lat': 52.2, 'lon': 0.11667}}, {'zip': 'CA2 7HY', 'city': 'Carlisle', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Cumberland Infirmary', 'geoPoint': {'lat': 54.8951, 'lon': -2.9382}}, {'zip': 'GL53 7AN', 'city': 'Cheltenham', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Gloucestershire Oncology Centre at Cheltenham General Hospital', 'geoPoint': {'lat': 51.90006, 'lon': -2.07972}}, {'zip': 'GL53 7AN', 'city': 'Cheltenham', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Gloucestershire Royal Hospital', 'geoPoint': {'lat': 51.90006, 'lon': -2.07972}}, {'zip': 'CV2 2DX', 'city': 'Coventry', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Walsgrave Hospital', 'geoPoint': {'lat': 52.40656, 'lon': -1.51217}}, {'zip': 'DN2 5LT', 'city': 'Doncaster', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Doncaster Royal Infirmary', 'geoPoint': {'lat': 53.52285, 'lon': -1.13116}}, {'zip': 'CM20 1QX', 'city': 'Essex', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Princess Alexandra Hospital'}, {'zip': 'EX2 5DW', 'city': 'Exeter', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Royal Devon and Exeter Hospital', 'geoPoint': {'lat': 50.7236, 'lon': -3.52751}}, {'zip': 'DN33 2BA', 'city': 'Grimsby', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Diana Princess of Wales Hospital', 'geoPoint': {'lat': 53.56539, 'lon': -0.07553}}, {'zip': 'GU2 7XX', 'city': 'Guildford', 'state': 'England', 'country': 'United Kingdom', 'facility': "St. Luke's Cancer Centre at Royal Surrey County Hospital", 'geoPoint': {'lat': 51.23536, 'lon': -0.57427}}, {'zip': 'HU8 9HE', 'city': 'Hull', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Princess Royal Hospital at Hull and East Yorkshire NHS Trust', 'geoPoint': {'lat': 53.7446, 'lon': -0.33525}}, {'zip': 'LS16 6QB', 'city': 'Leeds', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Cookridge Hospital', 'geoPoint': {'lat': 53.79648, 'lon': -1.54785}}, {'zip': 'LE1 5WW', 'city': 'Leicester', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Leicester Royal Infirmary', 'geoPoint': {'lat': 52.6386, 'lon': -1.13169}}, {'zip': 'LN2 5QY', 'city': 'Lincoln', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Lincoln County Hospital', 'geoPoint': {'lat': 53.22683, 'lon': -0.53792}}, {'zip': 'L7 8XP', 'city': 'Liverpool', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Royal Liverpool University Hospital', 'geoPoint': {'lat': 53.41058, 'lon': -2.97794}}, {'zip': 'L9 7AL', 'city': 'Liverpool', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Aintree University Hospital', 'geoPoint': {'lat': 53.41058, 'lon': 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'country': 'United Kingdom', 'facility': 'Clatterbridge Centre for Oncology'}, {'zip': 'TS4 3BW', 'city': 'Middlesbrough', 'state': 'England', 'country': 'United Kingdom', 'facility': 'James Cook University Hospital', 'geoPoint': {'lat': 54.57623, 'lon': -1.23483}}, {'zip': 'NE4 6BE', 'city': 'Newcastle upon Tyne', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Northern Centre for Cancer Treatment at Newcastle General Hospital', 'geoPoint': {'lat': 54.97328, 'lon': -1.61396}}, {'zip': 'HA6 2RN', 'city': 'Northwood', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Mount Vernon Cancer Centre at Mount Vernon Hospital', 'geoPoint': {'lat': 51.61162, 'lon': -0.42454}}, {'zip': 'NG5 1PB', 'city': 'Nottingham', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Nottingham City Hospital', 'geoPoint': {'lat': 52.9536, 'lon': -1.15047}}, {'zip': 'PE3 6DA', 'city': 'Peterborough', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Peterborough 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'country': 'United Kingdom', 'facility': 'Ninewells Hospital', 'geoPoint': {'lat': 56.46913, 'lon': -2.97489}}, {'zip': 'EH4 2XU', 'city': 'Edinburgh', 'state': 'Scotland', 'country': 'United Kingdom', 'facility': 'Edinburgh Cancer Centre at Western General Hospital', 'geoPoint': {'lat': 55.95206, 'lon': -3.19648}}, {'zip': 'G12 0YN', 'city': 'Glasgow', 'state': 'Scotland', 'country': 'United Kingdom', 'facility': 'Beatson West of Scotland Cancer Centre', 'geoPoint': {'lat': 55.86515, 'lon': -4.25763}}, {'zip': '1V2 3UJ', 'city': 'Inverness', 'state': 'Scotland', 'country': 'United Kingdom', 'facility': 'Raigmore Hospital', 'geoPoint': {'lat': 57.47908, 'lon': -4.22398}}, {'zip': 'CF14 2TL', 'city': 'Cardiff', 'state': 'Wales', 'country': 'United Kingdom', 'facility': 'Velindre Cancer Center at Velindre Hospital', 'geoPoint': {'lat': 51.48, 'lon': -3.18}}, {'zip': 'LL 18 5UJ', 'city': 'Rhyl, Denbighshire', 'state': 'Wales', 'country': 'United Kingdom', 'facility': 'Glan Clwyd Hospital', 'geoPoint': {'lat': 53.31929, 'lon': -3.49228}}, {'zip': 'SA2 8QA', 'city': 'Swansea', 'state': 'Wales', 'country': 'United Kingdom', 'facility': 'Singleton Hospital', 'geoPoint': {'lat': 51.62079, 'lon': -3.94323}}, {'zip': 'LL13 7TD', 'city': 'Wrexham', 'state': 'Wales', 'country': 'United Kingdom', 'facility': 'Wrexham Maelor Hospital', 'geoPoint': {'lat': 53.04664, 'lon': -2.99132}}], 'overallOfficials': [{'name': 'Tom Crosby, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Velindre NHS Trust'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wales Cancer Trials Unit', 'class': 'OTHER'}, 'collaborators': [{'name': 'Cancer Research UK', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}