Ignite Creation Date:
2025-12-25 @ 4:17 AM
Ignite Modification Date:
2025-12-26 @ 3:17 AM
Study NCT ID:
NCT05816720
Status:
COMPLETED
Last Update Posted:
2023-04-18
First Post:
2023-01-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Retrospective Analysis of Patients Re-treated With Lutetium-177 DOTATATE (Lutathera®)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018358', 'term': 'Neuroendocrine Tumors'}], 'ancestors': [{'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C447941', 'term': 'lutetium Lu 177 dotatate'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 31}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2022-01-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-04-16', 'studyFirstSubmitDate': '2023-01-30', 'studyFirstSubmitQcDate': '2023-04-16', 'lastUpdatePostDateStruct': {'date': '2023-04-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression-free survival', 'timeFrame': 'Up to approximately 11 years', 'description': 'Time from the index date of treatment or re-treatment with lutetium-177 DOTATATE until the date of progression or death'}, {'measure': 'Overall survival', 'timeFrame': 'Up to approximately 11 years', 'description': 'Time from the index date of treatment or re-treatment with lutetium-177 DOTATATE until the date of death'}, {'measure': 'Percentage of patients with treatment response', 'timeFrame': 'Up to approximately 11 years', 'description': 'Best overall response was defined per Response Evaluation Criteria In Solid Tumors (RECIST), 1.1. Overall response: complete response (CR) + partial response (PR); CR; PR; stable disease (SD); and progressive disease (PD)'}], 'secondaryOutcomes': [{'measure': 'Number of patients with adverse events (AEs)', 'timeFrame': 'Up to approximately 11 years'}, {'measure': 'Mean change from baseline in white blood cell (WBC) count', 'timeFrame': 'Up to approximately 11 years'}, {'measure': 'Mean change from baseline in hemoglobin', 'timeFrame': 'Up to approximately 11 years'}, {'measure': 'Mean change from baseline in absolute neutrophil count (ANC)', 'timeFrame': 'Up to approximately 11 years'}, {'measure': 'Mean change from baseline in lymphocyte count', 'timeFrame': 'Up to approximately 11 years'}, {'measure': 'Mean change from baseline in platelet count', 'timeFrame': 'Up to approximately 11 years'}, {'measure': 'Mean change from baseline in alkaline phosphatase (ALP)', 'timeFrame': 'Up to approximately 11 years'}, {'measure': 'Mean change from baseline in alanine aminotransferase (ALT)', 'timeFrame': 'Up to approximately 11 years'}, {'measure': 'Mean change from baseline in aspartate aminotransferase (AST)', 'timeFrame': 'Up to approximately 11 years'}, {'measure': 'Mean change from baseline in albumin', 'timeFrame': 'Up to approximately 11 years'}, {'measure': 'Mean change from baseline in bilirubin', 'timeFrame': 'Up to approximately 11 years'}, {'measure': 'Mean change from baseline in creatinine', 'timeFrame': 'Up to approximately 11 years'}, {'measure': 'Mean change from baseline in estimated glomerular filtration rate (eGFR)', 'timeFrame': 'Up to approximately 11 years'}, {'measure': 'Mean change from baseline in cromogranin A', 'timeFrame': 'Up to approximately 11 years'}, {'measure': 'Mean change from baseline in pancreatic polypeptide', 'timeFrame': 'Up to approximately 11 years'}, {'measure': 'Mean change from baseline in pancreastatin', 'timeFrame': 'Up to approximately 11 years'}, {'measure': 'Number of patients who received other treatments prior to initial treatment with lutetium-177 DOTATATE', 'timeFrame': 'Prior to initial treatment with lutetium-177 DOTATATE'}, {'measure': 'Number of patients who received lutetium-177 DOTATATE, categorized by number of doses', 'timeFrame': 'Up to approximately 11 years'}, {'measure': 'Number of patients who received lutetium-177 DOTATATE, categorized by treatment stage', 'timeFrame': 'Up to approximately 11 years'}, {'measure': 'Quantity of lutetium-177 DOTATATE administered, categorized by treatment stage', 'timeFrame': 'Up to approximately 11 years'}]}, 'conditionsModule': {'conditions': ['Neuroendocrine Tumor']}, 'descriptionModule': {'briefSummary': 'This was a retrospective non-interventional study evaluating the medical records of patients with neuroendocrine tumor (NET) re-treated with lutetium-177 DOTATATE at a single United States institution - the Excel Diagnostics \\& Nuclear Oncology Center in Houston, Texas. Initial treatment was defined as the initial regimen of up to 4 doses of Lutetium-177 DOTATATE received by each patient; re-treatment was defined as any additional dose(s) of lutetium-177 DOTATATE given after the patient progressed following the initial treatment, with a minimum time interval of 6 months between the initial treatment and re-treatment.\n\nThe study period was from 01 January 2010 to 30 June 2021. The index date was the date of the first ever treatment with lutetium-177 DOTATATE, and the index re-treatment date was the date of the first re-treatment dose of lutetium-177 DOTATATE received. The index (identification) period was from 01 July 2010 to 31 December 2020 to account for minimum 6-month baseline and follow-up periods. Patients were followed from the index date to the occurrence of one of the following events (whichever came first):\n\n1. Date of death - the date at which a patient was reported in the database as having died\n2. Last month active - the last recorded mention of the patient in the dataset\n3. End of data window - end of the dataset Patient characteristics were assessed at both the index date and the index re-treatment date. Real-world effectiveness and safety outcomes were also assessed from the index date and from the index re-treatment date.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This was a retrospective, noninterventional cohort study', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria\n\n* Diagnosis of any NET\n* Evidence of re-treatment with lutetium-177 DOTATATE\n\n * Documentation of initial treatment with a regimen of up to 4 doses of lutetium-177 DOTATATE, followed by evidence of progression, and then ≥1 subsequent dose of lutetium-177 DOTATATE\n * Minimum of 6 months between the end of the initial treatment doses and the first re-treatment dose\n\nExclusion criteria\n\n• \\<18 years of age'}, 'identificationModule': {'nctId': 'NCT05816720', 'briefTitle': 'Retrospective Analysis of Patients Re-treated With Lutetium-177 DOTATATE (Lutathera®)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'Retrospective Analysis of Patients Re-treated With Lutetium-177 DOTATATE (Lutathera®)', 'orgStudyIdInfo': {'id': 'CAAA601A1US08'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Initial treatment', 'description': 'Patients who received initial treatment with lutetium-177 DOTATATE', 'interventionNames': ['Drug: Lutetium-177 DOTATATE']}, {'label': 'Re-treatment', 'description': 'Patients who received re-treatment with lutetium-177 DOTATATE', 'interventionNames': ['Drug: Lutetium-177 DOTATATE']}, {'label': 'Additional re-treatment', 'description': 'Patients who received additional re-treatment with lutetium-177 DOTATATE', 'interventionNames': ['Drug: Lutetium-177 DOTATATE']}], 'interventions': [{'name': 'Lutetium-177 DOTATATE', 'type': 'DRUG', 'otherNames': ['Lutathera®'], 'description': 'Intravenous administration', 'armGroupLabels': ['Additional re-treatment', 'Initial treatment', 'Re-treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77042', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Excel Diagnostics & Nuclear Oncology Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Novartis Pharmaceuticals', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novartis Pharmaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}