Ignite Creation Date:
2025-12-25 @ 1:43 AM
Ignite Modification Date:
2026-01-06 @ 12:42 PM
Study NCT ID:
NCT00953394
Status:
COMPLETED
Last Update Posted:
2009-08-06
First Post:
2009-08-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
5FU and Octreotide Long-acting Release (LAR) for Neuroendocrine Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018358', 'term': 'Neuroendocrine Tumors'}, {'id': 'D018278', 'term': 'Carcinoma, Neuroendocrine'}], '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': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 29}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-08', 'completionDateStruct': {'date': '2006-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-08-05', 'studyFirstSubmitDate': '2009-08-05', 'studyFirstSubmitQcDate': '2009-08-05', 'lastUpdatePostDateStruct': {'date': '2009-08-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-08-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'disease free survival', 'timeFrame': '50 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['octreotide LAR', 'neuroendocrine carcinoma', 'metronomic 5fluorouracil'], 'conditions': ['Neuroendocrine Tumors']}, 'referencesModule': {'references': [{'pmid': '19886987', 'type': 'DERIVED', 'citation': 'Brizzi MP, Berruti A, Ferrero A, Milanesi E, Volante M, Castiglione F, Birocco N, Bombaci S, Perroni D, Ferretti B, Alabiso O, Ciuffreda L, Bertetto O, Papotti M, Dogliotti L. Continuous 5-fluorouracil infusion plus long acting octreotide in advanced well-differentiated neuroendocrine carcinomas. A phase II trial of the Piemonte oncology network. BMC Cancer. 2009 Nov 3;9:388. doi: 10.1186/1471-2407-9-388.'}]}, 'descriptionModule': {'briefSummary': 'Well differentiated neuroendocrine carcinomas have low proliferative activity and conventional chemotherapy is not recommended. Metronomic chemotherapy, i.e. the frequent administration of cytotoxic drugs at low doses, has demonstrated antiangiogenetic properties. Since well differentiated NE carcinomas are highly vascular, there is a rationale for testing metronomic chemotherapy in this clinical setting.\n\nA phase II study was designed to test the activity of protracted 5-fluorouracil (5FU) infusion plus long-acting release (LAR) octreotide for patients with neuroendocrine carcinoma.', 'detailedDescription': 'Metastatic or locally advanced well differentiated neuroendocrine carcinoma were treated with 5Fluorouracil protracted intravenous infusion (200 mg/m2 daily) plus Octreotide LAR (20 mg monthly).\n\nPrimary Endpoint: the response to treatment, evaluated according to the RECIST criteria.\n\nSecondary Endpoints:\n\n* toxicity, graded according to the NCI-CTG criteria;\n* symptomatic response: evaluated according to the changes in both the frequency and intensity of symptoms;\n* biochemical response: evaluated considering the changes in the tumor marker levels (circulating Chromogranin A);\n* time to progression and survival: were measured from the date of treatment start to the date of progression and the date of last follow-up or death, respectively.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* histological diagnosis of well-differentiated neuroendocrine carcinoma according to the World Health Organization (WHO) classification;\n* locally advanced or metastatic disease not amenable to surgery with radical intent;\n* at least one measurable target lesion;\n* radiological documentation of progressive disease;\n* ECOG performance status grade \\<=2;\n* life expectancy \\>12 weeks;\n* adequate bone marrow reserve;\n* adequate hepatic and renal function;\n* ability to comply with the protocol procedures (including geographic accessibility);\n* written informed consent.\n\nExclusion Criteria:\n\n* non-malignant systemic disease or conditions that precluded patients from receiving the study therapy;\n* second primary malignancies and previous systemic antineoplastic treatment including somatostatin analogues;\n* history of prior malignancy, excepted for cured non-melanoma skin cancer, and cured in situ cervical carcinoma.'}, 'identificationModule': {'nctId': 'NCT00953394', 'briefTitle': '5FU and Octreotide Long-acting Release (LAR) for Neuroendocrine Tumors', 'organization': {'class': 'OTHER', 'fullName': 'University of Turin, Italy'}, 'officialTitle': 'Continuous 5-fluorouracil Infusion Plus Long Acting Octreotide in Advanced Well Differentiated Neuroendocrine Carcinomas. A Phase II Trial of the Piemonte Oncology Network.', 'orgStudyIdInfo': {'id': 'EudraCT 2004-003963-58'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'treatment arm', 'description': 'continuous 5 fluouracil infusion plus long-acting octreotide', 'interventionNames': ['Drug: continuous 5 fluouracil infusion plus long-acting octreotide']}], 'interventions': [{'name': 'continuous 5 fluouracil infusion plus long-acting octreotide', 'type': 'DRUG', 'otherNames': ['metronomic 5 fluouracil infusion plus long-acting octreotide'], 'description': 'long-acting octreotide acetate at a dose of 20 mg was administered intramuscularly every 4 weeks. 5fluorouracil was given as a protracted continuous infusion without interruption at a daily dose of 200 mg/m2 of body-surface area through an elastomeric pump connected to a central venous access.', 'armGroupLabels': ['treatment arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '12051', 'city': 'Alba', 'state': 'Cuneo', 'country': 'Italy', 'facility': 'Federico Castiglione', 'geoPoint': {'lat': 44.6999, 'lon': 8.0347}}, {'zip': '12037', 'city': 'Saluzzo', 'state': 'Cuneo', 'country': 'Italy', 'facility': 'Davide Perroni', 'geoPoint': {'lat': 44.64671, 'lon': 7.49309}}, {'zip': '62027', 'city': 'San Severino Marche', 'state': 'Macerata', 'country': 'Italy', 'facility': 'Benedetta Ferretti', 'geoPoint': {'lat': 43.23028, 'lon': 13.1799}}, {'zip': '10015', 'city': 'Ivrea', 'state': 'Torino', 'country': 'Italy', 'facility': 'Sebastiano Bombaci', 'geoPoint': {'lat': 45.46723, 'lon': 7.87617}}, {'zip': '10043', 'city': 'Orbassano', 'state': 'Torino', 'country': 'Italy', 'facility': 'Anna Ferrero', 'geoPoint': {'lat': 45.00547, 'lon': 7.53813}}, {'zip': '28100', 'city': 'Novara', 'country': 'Italy', 'facility': 'Oscar Alabiso', 'geoPoint': {'lat': 45.44694, 'lon': 8.62118}}, {'zip': '10126', 'city': 'Torino', 'country': 'Italy', 'facility': 'Enrica Milanesi', 'geoPoint': {'lat': 44.88856, 'lon': 11.99138}}], 'overallOfficials': [{'name': 'Alfredo Berruti, PHD', 'role': 'STUDY_CHAIR', 'affiliation': 'Medical oncology, Department of Clinical and Biological Sciences, University of Turin'}, {'name': 'Luigi Dogliotti, PHD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Medical oncology, Department of Clinical and Biological Sciences, University of Turin'}, {'name': 'Libero Ciuffreda, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centro Oncologico Ematologico Subalpino, Azienda Ospedaliera Molinette, Torino'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Turin, Italy', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Alfredo Berruti', 'oldOrganization': 'Dipartimento di Scienze Cliniche e Biologiche'}}}}