Ignite Creation Date:
2025-12-25 @ 3:32 AM
Ignite Modification Date:
2025-12-26 @ 2:15 AM
Study NCT ID:
NCT01463605
Status:
COMPLETED
Last Update Posted:
2021-02-04
First Post:
2011-10-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Nimotuzumab Combined With Radiotherapy for Older Patients With Esophageal Cancer: a Single, Non-control Clinical Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004938', 'term': 'Esophageal Neoplasms'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C501466', 'term': 'nimotuzumab'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 46}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2020-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-02', 'studyFirstSubmitDate': '2011-10-30', 'studyFirstSubmitQcDate': '2011-11-01', 'lastUpdatePostDateStruct': {'date': '2021-02-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-11-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety of Nimotuzumab combined with Radiotherapy for older patients', 'timeFrame': '2 years', 'description': 'To observe the adverse events during the treatment'}], 'secondaryOutcomes': [{'measure': 'Efficacy of Nimotuzumab combined with Radiotherapy for older esophageal cancer patients', 'timeFrame': '3 years', 'description': 'To observe the response rate, progress-free survival and overall survival'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['radiotherapy', 'targeted therapy', 'esophageal cancer', 'older'], 'conditions': ['Esophageal Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.elsevierhealth.com/journals/ctrv', 'label': 'This review discuss pre-clinical data and the rationale for targeting these pathways and summarize the results of clinical trials to-date.'}, {'url': 'http://www.ncbi.nlm.nih.gov/sites/entrez', 'label': 'Changing healthcare practice of older adults with late-stage non-small cell lung cancer: practical considerations of targeted therapy in primary care and oncology.'}]}, 'descriptionModule': {'briefSummary': 'For patients who are unable to receive surgery or having local advanced esophageal cancer stages, concurrent chemoradiotherapy is recommended. But radiotherapy is the main strategy for older patients because of their chemoradiotherapy intolerance. The whole world focused on targeted therapy which has strong specialties and mild toxicities. So combined targeted therapy and radiotherapy may be a novel strategy for older patients with esophageal cancer. Nimotuzumab is a EGFR monoclonal antibody. This clinical trial is to study the effect and safety of Nimotuzumab in combined with radiotherapy for older patients with esophageal cancer. All patients receive intensity modulated radiotherapy with conventional fraction. Nimotuzumab with 200mg is given weekly for all patients during radiotherapy.', 'detailedDescription': 'Study Design Primary Purpose: To evaluate the response rate, progression-free survival, overall survival and complications.\n\nStudy Phase: Phase II Intervention Model: Targeted therapy combined with radiotherapy Number of Arms: One Masking: No Allocation: 30 patients for one single group Enrollment: 30 patients\n\nEligibility Criteria Inclusion Criteria: 1. ≥ 70 year-old, 2. Thoracic segment esophageal cancer with stage II to IV (supraclavicular lymph node metastasis only), 3. No previous surgery, radiotherapy or chemotherapy of cancer was allowed, 4. Estimated survival time ≥ 3 months, 5. KPS \\> 60, 6. No serious diseases of important organs, 7. Signed consent forms voluntarily.\n\nExclusion Criteria: 1. Psychopath, 2. History of other malignant disease which has not been cured, 3. Joining other clinical trial prior this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '70 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. patients aged 70 years or older;\n2. treatment naive patients with histologically proven thoracic-segment EC that was inoperable and who could not tolerate CCRT;\n3. stage II-IV disease (supraclavicular lymph node metastasis only), according to the 6th American Joint Committee on Cancer TNM staging system;\n4. estimated survival time ≥3 months;\n5. Karnofsky performance score ≥70;\n6. adequate bone marrow, as well as hepatic and renal function;\n7. voluntary written consent provided prior to treatment.\n\nExclusion Criteria:\n\n1. esophagobronchial or esophagomediastinal fistula;\n2. patients who had joined other clinical trials prior to this treatment;\n3. serious heart, liver, and/or kidney insufficiency;\n4. serious infectious disease;\n5. relapse disease or distant metastasis;\n6. recently diagnosed neoplastic diseases;\n7. previous receipt of surgery, chemotherapy, or radiotherapy for EC.'}, 'identificationModule': {'nctId': 'NCT01463605', 'briefTitle': 'Nimotuzumab Combined With Radiotherapy for Older Patients With Esophageal Cancer: a Single, Non-control Clinical Trial', 'organization': {'class': 'UNKNOWN', 'fullName': 'ChineseAMS'}, 'officialTitle': 'Nimotuzumab Combined With Radiotherapy for Older Patients With Esophageal Cancer: a Single, Non-control Phase II Clinical Trial', 'orgStudyIdInfo': {'id': '11-49/484'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'radiotherapy', 'description': 'It is just a single group assignment', 'interventionNames': ['Drug: Nimotuzumab']}], 'interventions': [{'name': 'Nimotuzumab', 'type': 'DRUG', 'description': 'Nimotuzumab 200mg,once per week,for 5 to 6 weeks', 'armGroupLabels': ['radiotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100021', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Cancer Hospital, Chinese Academy of Medical Sciences', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'overallOfficials': [{'name': 'Liang Jun, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Radiation Oncology, Cancer Hospital, Chinese Academy of Medical Sciences'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chinese Academy of Medical Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Radiation Oncology, Cancer Hospital, Chinese Academy of Medical Sciences', 'investigatorFullName': 'Liang Jun', 'investigatorAffiliation': 'Chinese Academy of Medical Sciences'}}}}