Ignite Creation Date:
2025-12-25 @ 4:15 AM
Ignite Modification Date:
2026-03-09 @ 6:05 AM
Study NCT ID:
NCT00815620
Status:
COMPLETED
Last Update Posted:
2017-03-21
First Post:
2008-12-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Best Therapy for Patients With Neuroendocrine Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018358', 'term': 'Neuroendocrine Tumors'}, {'id': 'D001835', 'term': 'Body Weight'}], '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'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2017-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-20', 'studyFirstSubmitDate': '2008-12-29', 'studyFirstSubmitQcDate': '2008-12-29', 'lastUpdatePostDateStruct': {'date': '2017-03-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-12-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'progression-free survival', 'timeFrame': '2 years'}], 'secondaryOutcomes': [{'measure': 'overall survival, quality of life (EORTC-QLQ30), weight, time of hospitalization, Karnofsky index', 'timeFrame': '2 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['neuroendocrine tumors', 'transcatheter arterial chemoembolization', 'selective internal radiotherapy', 'surgery', 'radio-frequency ablation', 'peptide-receptor radiotherapy', 'progression-free survival', 'quality of life', 'overall survival', 'weight', 'time of hospitalization'], 'conditions': ['Neuroendocrine Tumors']}, 'descriptionModule': {'briefSummary': 'A prospective observational study containing three arms comprising different therapeutic measures to treat patients with neuroendocrine tumors in advanced stages. The therapy arms include local ablative therapy such as TACE or SIRT, surgery and RFA with peptide receptor radiotherapy.', 'detailedDescription': 'Study design:\n\nProspective observational study comparing ablative measures as TACE or SIRT with surgery/RFA and with peptide receptor radio-therapy in patients with advanced well-differentiated neuroendocrine tumors with lymph node or distant metastases (N1, M1) Prospective evaluation Primary end points: time to progression Secondary end points: survival, quality of life (EORTC-QLQ30), weight, time of hospitalization, Karnofsky index) Non-randomized cohort study Number of patients needed in all groups: 70 per group, 210 overall Evaluation of response to therapy every 3-6 months by imaging, clinical status, weight, quality of life, Karnofsky-index Cross-over allowed if therapy changes'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients with neuroendocrine tumors in a tertiary referal center', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Biopsy-proven neuroendocrine tumor (WHO class I-II, TNM grading 1-2)\n* Advanced disease with lymph node or distant metastases (N1, M1) undergoing cytoreduction by surgery/local ablative therapy or peptide receptor radiotherapy\n* curative intent of all therapies possible\n\nExclusion Criteria:\n\n* Undifferentiated neuroendocrine carcinoma (WHO class III, TNM grading 3)\n* secondary tumor\n* advanced carcinoid heart disease requiring surgery'}, 'identificationModule': {'nctId': 'NCT00815620', 'acronym': 'BESTTHERAPYNET', 'briefTitle': 'Best Therapy for Patients With Neuroendocrine Tumors', 'organization': {'class': 'OTHER', 'fullName': 'Zentralklinik Bad Berka'}, 'officialTitle': 'Best Therapy for Patients With Neuroendocrine Tumors', 'orgStudyIdInfo': {'id': 'ZBB-NET-1'}}, 'armsInterventionsModule': {'armGroups': [{'label': '1', 'description': 'patients undergoing local ablative therapy such as transcatheter-arterial chemoembolization or selective interal radiotherapy'}, {'label': '2', 'description': 'patients undergoing surgery or radiofrequency ablation'}, {'label': '3', 'description': 'patients undergoing peptide receptor radiotherapy'}]}, 'contactsLocationsModule': {'locations': [{'zip': '99437', 'city': 'Bad Berka', 'country': 'Germany', 'facility': 'Zentralklinik Bad Berka', 'geoPoint': {'lat': 50.89982, 'lon': 11.28245}}], 'overallOfficials': [{'name': 'Dieter Hörsch, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Zentralklinik Bad Berka GmbH'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zentralklinik Bad Berka', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Senior consultant', 'investigatorFullName': 'Dieter Hoersch MD', 'investigatorAffiliation': 'Zentralklinik Bad Berka'}}}}