Ignite Creation Date:
2025-12-25 @ 4:04 AM
Ignite Modification Date:
2025-12-26 @ 3:00 AM
Study NCT ID:
NCT01211002
Status:
UNKNOWN
Last Update Posted:
2010-09-29
First Post:
2010-09-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study of Concurrent Chemo-radiotherapy Combined With Recombinant Human Endostatin for Local Advanced Non-small Cell Lung Cancer (NSCLC)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}], 'ancestors': [{'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011878', 'term': 'Radiotherapy'}, {'id': 'D043169', 'term': 'Endostatins'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D043165', 'term': 'Angiostatic Proteins'}, {'id': 'D042501', 'term': 'Angiogenic Proteins'}, {'id': 'D036341', 'term': 'Intercellular Signaling Peptides and Proteins'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D043170', 'term': 'Collagen Type XVIII'}, {'id': 'D024041', 'term': 'Non-Fibrillar Collagens'}, {'id': 'D003094', 'term': 'Collagen'}, {'id': 'D016326', 'term': 'Extracellular Matrix Proteins'}, {'id': 'D012596', 'term': 'Scleroproteins'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 170}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2010-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-09', 'completionDateStruct': {'date': '2012-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2010-09-28', 'studyFirstSubmitDate': '2010-09-27', 'studyFirstSubmitQcDate': '2010-09-28', 'lastUpdatePostDateStruct': {'date': '2010-09-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-09-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'overall survival (OS)', 'timeFrame': '3 years'}], 'secondaryOutcomes': [{'measure': 'quality of life', 'timeFrame': '2 years'}, {'measure': 'objective response rate (ORR)', 'timeFrame': '1 years'}, {'measure': 'disease control rate (DCR)', 'timeFrame': '1 year'}, {'measure': 'progression-free survival (PFS)', 'timeFrame': '2 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Radiotherapy', 'rh-endostatin', 'chemotherapy', 'NSCLC'], 'conditions': ['Non-small Cell Lung Cancer']}, 'descriptionModule': {'briefSummary': 'It is a trials to evaluate the overall survival (OS) of radiotherapy / EP combined with recombinant human endostatin in treatment of locally advanced (Ⅲ A / unresectable Ⅲ B) non-small cell lung cancer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients with pathologically or histologically confirmed and inoperable stage Ⅲ (Ⅲ A or unresectable Ⅲ B) NSCLC;\n2. Patients with ages of 18\\~70 years, general condition ECOG performance scale （PS）≤ 1, weight loss \\<10% during last 6 months;\n3. CT films of patients during last 4 weeks were accessible when patients were selected into the groups, the lesions were measurable; (According to the standard of RECIST1.1, they should have at least one of accurately measurable lesions with the largest diameter ≥ 10mm by spiral CT, PET-CT, with the largest diameter≥ 20mm by ordinary CT and MRI.）\n4. No major organ dysfunction, the function of heart, liver and kidney was normal, laboratory indicators should meet the following requirements: Blood: WBC\\> 4.0 × 109 / L, absolute neutrophil count \\> 1.5 × 109 / L, platelet count\\> 100 × 109 / L, hemoglobin\\> 110g / L; liver function: serum bilirubin was less than 1.5 × maximum normal value ; ALT and AST were less than 1.5 × maximum normal value; BUN, Cr within the normal range; FEV1 \\> 1L or\\> 40% of predicted value;\n5. Patients could understand the circumstances of this study and those who have signed the informed consent form;\n\nExclusion Criteria:\n\n1. Pregnant or lactating women; women of child-bearing age without contraception;\n2. Acute infection or other serious underlying diseases;\n3. Significant neurological, psychiatric history, including dementia which may influence the ability to understand and the informed consent;\n4. Receive the treatment of other experimental trials in the same period; on the medication of other anticancer drugs a the same time; have joined other drug clinical trials 30 days before this clinical trial;\n5. Diabetes without control (blood-glucose is unstable or ≥ 8mol / L after administration);\n6. Patients who are allergic to E. coli preparation;\n7. Patients who are unsuitable to participate in this trial determined by the researchers.'}, 'identificationModule': {'nctId': 'NCT01211002', 'briefTitle': 'Study of Concurrent Chemo-radiotherapy Combined With Recombinant Human Endostatin for Local Advanced Non-small Cell Lung Cancer (NSCLC)', 'organization': {'class': 'OTHER', 'fullName': 'Simcere Pharmaceutical Co., Ltd'}, 'officialTitle': 'The Exploratory Clinical Study of Concurrent Chemo-radiotherapy Combined With Recombinant Human Endostatin (Endostar) for Local Advanced Non-small Cell Lung Cancer (NSCLC (Ⅲ A / Ⅲ B) )', 'orgStudyIdInfo': {'id': 'sim201002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'radiotherapy combined with EP', 'description': 'the dose of radiotherapy is 60-66 Gy / 30-33f.The combination regimen is etoposide (50 mg/m2 day1-5, 29-33) and cisplatin (50 mg/m2 day1, 8, 29, 36) in the 1st, 4th weeks of radiotherapy for 2 courses.', 'interventionNames': ['Radiation: radiotherapy combined with EP']}, {'type': 'EXPERIMENTAL', 'label': 'adiotherapy / EP /recombinant human endostatin', 'description': 'recombinant human endostatin: The number of courses is 3 \\~ 4 and each course last for 28 days.dose:15mg，d1-14, intravenous injection.', 'interventionNames': ['Drug: radiotherapy / EP combined with recombinant human endostatin']}], 'interventions': [{'name': 'radiotherapy combined with EP', 'type': 'RADIATION', 'description': 'Tumor vo lume is 60-66 Gy / 30-33f and the combination regimen is etoposide (50 mg/m2 day1-5, 29-33) and cisplatin (50 mg/m2 day1, 8, 29, 36) in the 1st, 4th weeks of radiotherapy for 2 courses.', 'armGroupLabels': ['radiotherapy combined with EP']}, {'name': 'radiotherapy / EP combined with recombinant human endostatin', 'type': 'DRUG', 'description': 'Anti-vascular targeting therapy The number of courses is 3 \\~ 4 and each course last for 28 days. Recombinant human endostatin（Endostar）：15mg，d1-14, intravenous injection.', 'armGroupLabels': ['adiotherapy / EP /recombinant human endostatin']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Chongqin', 'country': 'China', 'contacts': [{'name': 'zhenzhou yang, M.D.', 'role': 'CONTACT', 'email': 'yangzhenzhou@sohu.com'}, {'name': 'zhenzhou yang, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Daping Hospital'}], 'centralContacts': [{'name': 'Zhenzhou Yang, M.D.', 'role': 'CONTACT', 'email': 'yangzhenzhou@sohu.com'}], 'overallOfficials': [{'name': 'zhenzhou yang, M.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'Daping Hospital and the Research Institute of Surgery of the Third Military Medical University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Simcere Pharmaceutical Co., Ltd', 'class': 'OTHER'}, 'collaborators': [{'name': 'Daping Hospital and the Research Institute of Surgery of the Third Military Medical University', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Zhenzhou Yang M.D.', 'oldOrganization': 'Daping Hospital and Research Institute of Surgery of Third Military Medical University'}}}}