Ignite Creation Date:
2025-12-25 @ 12:14 AM
Ignite Modification Date:
2025-12-28 @ 1:08 AM
Study NCT ID:
NCT03802058
Status:
TERMINATED
Last Update Posted:
2023-04-28
First Post:
2019-01-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Concurrent Nab-P/Carboplatin and Thoracic Radiotherapy in Squamous Cell Lung Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}, {'id': 'D002294', 'term': 'Carcinoma, Squamous Cell'}], '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'}, {'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': 'C520255', 'term': '130-nm albumin-bound paclitaxel'}, {'id': 'D016190', 'term': 'Carboplatin'}], 'ancestors': [{'id': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'whyStopped': 'The study was halted because enrollment was too slow', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2019-03-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2021-12-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-04-27', 'studyFirstSubmitDate': '2019-01-06', 'studyFirstSubmitQcDate': '2019-01-09', 'lastUpdatePostDateStruct': {'date': '2023-04-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-01-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PFS (progression-free survival )', 'timeFrame': '5 years from patient enrollment', 'description': 'PFS is defined as time from the start of treatment to death, progression of disease, or the last follow-up data, whichever comes first. Progression is evaluated using Response Evaluation Criteria In Solid Tumors (RECIST) 1.1. PFS will be analyzed using the Kaplan-Meier method.'}], 'secondaryOutcomes': [{'measure': 'ORR (Overall Response Rate )', 'timeFrame': 'one month after the end of all treatment', 'description': 'The number of participants that achieve either a complete response (CR) or a partial response (PR). Response is evaluated using Response Evaluation Criteria In Solid Tumors (RECIST) 1.1.'}, {'measure': 'LCR (Local Control Rate)', 'timeFrame': 'one month after the end of all treatment', 'description': 'The number of participants that achieve either a complete response (CR) , a partial response (PR) or stable disease(SD).'}, {'measure': 'OS (Overall survival)', 'timeFrame': '5 years from patient enrollment', 'description': 'Overall survival is defined as time from the start of treatment until death. Overall survival will be analyzed using the Kaplan-Meier method.'}, {'measure': 'Number of participants with adverse events as assessed by CTCAE v4.0', 'timeFrame': '5 years from patient enrollment', 'description': 'The adverse events(AE) is evaluated by National Cancer Institute- Common Terminology Criteria for Adverse Events(NCI -CTCAE) 4.02.'}, {'measure': 'Patient quality of life (QOL)', 'timeFrame': '5 years from patient enrollment', 'description': 'Measured by the Functional Assessment of Cancer Therapy - Lung (FACT-L).The total range of scores:0-144,and higher values represent a better outcome.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Carcinoma, Non-Small-Cell Lung', 'Squamous Cell Carcinoma']}, 'descriptionModule': {'briefSummary': 'Nab-paclitaxel and carboplatin showed better treatment response compared with cremophor-based paclitaxel and carboplatin as first-line therapy in advanced non-small cell lung cancer, especially for squamous cell cancer. This study is conducted to evaluate the efficacy and safety of nab-paclitaxel, carboplatin and concurrent radiotherapy in patients with local advanced inoperable squamous cell lung cancer.', 'detailedDescription': 'This study was conducted to explore the efficacy and safety of concurrent concurrent nab-paclitaxel, carboplatin and thoracic radiotherapy in inoperable local advanced squamous cell lung cancer. Patients will be given nab-paclitaxel weekly at a dose of 40mg/m2, in combination with carboplatin (AUC 2) weekly during concurrent chemoradiotherapy. Thoracic radiation was administered at a dose of 60-66 Gy/30-33 fractions, both 3 dimensional conformal and intensity modulated radiation therapy are allowed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age: 18 Years to 70 Years\n* Performance status of 0 to 1 on the Eastern Cooperative Oncology Group (ECOG) Scale.\n* Previously untreated, histological documented, inoperable stage III squamous cell carcinoma of lung, excluding those with pericardial, pleural effusion, and those with contralateral hilar or contralateral supraclavicular lymph nodes.\n* Patients must have measurable disease according to RECIST criteria, and all detectable tumor can be encompassed by radiation therapy fields.\n* Patient must have adequate blood, liver, lungs and kidney function within the requirements of this study.\n* Female patients of child-bearing potential must test negative for pregnancy at the time of enrollment based on a serum pregnancy test. Male and female patients must agree to use a reliable method of birth control during and for 3 months following the last dose of study drug.\n* Patients must sign a study-specific informed consent form prior to study entry.\n\nExclusion Criteria:\n\n* Complete tumor resection, recurrent disease, or those patients eligible for definitive surgery.\n* Previous chemotherapy or previous biologic response modifiers for current lung cancer.\n* Patient has previously had thoracic radiation therapy.\n* Prior or concurrent malignancy except non-melanomatous skin cancer unless disease-free for five years or more.\n* Serious concomitant disorders that would compromise the safety of the patient, or compromise the patient's ability to complete the study, at the discretion of the investigator.\n* History of significant neurological or mental disorder, including seizures or dementia."}, 'identificationModule': {'nctId': 'NCT03802058', 'briefTitle': 'Concurrent Nab-P/Carboplatin and Thoracic Radiotherapy in Squamous Cell Lung Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Wuhan University'}, 'officialTitle': 'Concurrent Nab--paclitaxel/Carboplatin and Thoracic Radiotherapy in Inoperable Stage III Squamous Cell Lung Cancer', 'orgStudyIdInfo': {'id': 'Nab-P RT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Nab-paclitaxel', 'description': 'Nab-paclitaxel and carboplatin for Injection; thoracic radiation therapy', 'interventionNames': ['Drug: Nab-paclitaxel', 'Drug: Carboplatin', 'Radiation: Thoracic radiation therapy']}], 'interventions': [{'name': 'Nab-paclitaxel', 'type': 'DRUG', 'otherNames': ['Nab-P'], 'description': 'Nab-paclitaxel 40mg/m2 for Injection weekly', 'armGroupLabels': ['Nab-paclitaxel']}, {'name': 'Carboplatin', 'type': 'DRUG', 'otherNames': ['CBP'], 'description': 'Carboplatin AUC=2 for Injection weekly', 'armGroupLabels': ['Nab-paclitaxel']}, {'name': 'Thoracic radiation therapy', 'type': 'RADIATION', 'otherNames': ['RT'], 'description': 'Thoracic radiation therapy 60-66Gy/30-33 fractions,both three-dimensional conformal and intensity modulated radiation therapy are allowed', 'armGroupLabels': ['Nab-paclitaxel']}]}, 'contactsLocationsModule': {'locations': [{'zip': '430071', 'city': 'Wuhan', 'state': 'Hubei', 'country': 'China', 'facility': 'Zhongnan Hospital of Wuhan University', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}], 'overallOfficials': [{'name': 'Conghua Xie, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wuhan University'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': '2 years after the end of the study', 'ipdSharing': 'YES', 'description': 'all IPD can be shared by all researchers who participate in this study by e-mail contact', 'accessCriteria': 'Researchers who participate in this study'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wuhan University', 'class': 'OTHER'}, 'collaborators': [{'name': 'CSPC Ouyi Pharmaceutical Co., Ltd.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'director of Department of Radiation and Medical Oncology, Zhongnan Hospital', 'investigatorFullName': 'Conghua Xie,MD,PhD', 'investigatorAffiliation': 'Wuhan University'}}}}