Ignite Creation Date:
2025-12-24 @ 10:52 PM
Ignite Modification Date:
2025-12-25 @ 8:21 PM
Study NCT ID:
NCT00332969
Status:
COMPLETED
Last Update Posted:
2017-03-31
First Post:
2006-06-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy of Octreotide Treatment in Patients With Primary Inoperable Thymoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013945', 'term': 'Thymoma'}, {'id': 'D004194', 'term': 'Disease'}, {'id': 'D009369', 'term': 'Neoplasms'}], 'ancestors': [{'id': 'D018193', 'term': 'Neoplasms, Complex and Mixed'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D013953', 'term': 'Thymus Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015282', 'term': 'Octreotide'}], 'ancestors': [{'id': 'D010456', 'term': 'Peptides, Cyclic'}, {'id': 'D047028', 'term': 'Macrocyclic Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-11', 'lastUpdateSubmitDate': '2017-03-30', 'studyFirstSubmitDate': '2006-06-01', 'studyFirstSubmitQcDate': '2006-06-01', 'lastUpdatePostDateStruct': {'date': '2017-03-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2006-06-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Shrinkage of tumor size and diameter of 3 respectively 6 months', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'Resection status after 3 respectively 6 months', 'timeFrame': '3 - 6 months'}]}, 'conditionsModule': {'keywords': ['Open label', 'phase II', 'disease', 'clinical trial', 'Octreotide', 'thymoma', 'cancer', 'tumor'], 'conditions': ['Thymoma']}, 'referencesModule': {'references': [{'pmid': '27992479', 'type': 'RESULT', 'citation': 'Kirzinger L, Boy S, Marienhagen J, Schuierer G, Neu R, Ried M, Hofmann HS, Wiebe K, Strobel P, May C, Kleylein-Sohn J, Baierlein C, Bogdahn U, Marx A, Schalke B. Octreotide LAR and Prednisone as Neoadjuvant Treatment in Patients with Primary or Locally Recurrent Unresectable Thymic Tumors: A Phase II Study. PLoS One. 2016 Dec 16;11(12):e0168215. doi: 10.1371/journal.pone.0168215. eCollection 2016.'}]}, 'descriptionModule': {'briefSummary': 'This study will investigate the efficacy of treatment with octroetide in patients with primary inoperable thymoma to reduce tumor size.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Male or female patients aged \\>18 years\n2. Inoperability of thymic tumor. Inoperability is defined as at least adherence of the tumor to the neighbour organs, suspicious to infiltrate neighbour organs so that R0 resection cannot be expected.\n3. Positive result in SMS-szintigraphy,\n4. Thymomas of all WHO based histological subtypes (Rosai, 1999; Travis 2004) at Masaoka stage III based on histological examination of core biopsies or resection specimens.\n5. Patients with and without thymoma associated paraneoplastic syndrome\n6. Demonstrated tolerance to a test dose of s.c. octreotide injection at Visit 1.\n\nExclusion Criteria:\n\n1. Performance status 0,1, or 2 (ECOG)\n2. Symptomatic cholelithiasis,\n3. Pretreatment with octreotide (longn acting release) within the 3 months\n4. Patient has received any other investigational agents within 28 days of first day of study drug dosing\n5. Patient is \\< 5 years free of another primary malignancy except: if the other primary malignancy is not currently clinically significant nor requiring active intervention, or if other primary malignancy is a basal cell skin cancer or a cervical carcinoma in situ. Existence of any other malignant disease is not allowed\n6. Grade III/IV cardiac problems as defined by the New York Heart Association Criteria. (i.e., congestive heart failure, myocardial infarction within 6 months of study)\n\nOther protocol-defined inclusion/exclusion criteria apply'}, 'identificationModule': {'nctId': 'NCT00332969', 'briefTitle': 'Efficacy of Octreotide Treatment in Patients With Primary Inoperable Thymoma', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'Efficacy of Medical Treatment With Octreotide in Patients With Primary Inoperable Thymoma to Reduce Tumor Size', 'orgStudyIdInfo': {'id': 'CSMS995ADE13'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sandostatin', 'interventionNames': ['Drug: Octreotide']}], 'interventions': [{'name': 'Octreotide', 'type': 'DRUG', 'armGroupLabels': ['Sandostatin']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Regensburg', 'country': 'Germany', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 49.01513, 'lon': 12.10161}}], 'overallOfficials': [{'name': 'Novartis Pharmaceuticals', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novartis Pharmeceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}