Ignite Creation Date:
2025-12-24 @ 2:29 PM
Ignite Modification Date:
2025-12-28 @ 8:36 AM
Study NCT ID:
NCT00416559
Status:
UNKNOWN
Last Update Posted:
2013-09-20
First Post:
2006-12-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Observation of Young Patients With Localized Neuroblastoma Who Have Undergone Surgery Only
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009447', 'term': 'Neuroblastoma'}], 'ancestors': [{'id': 'D018241', 'term': 'Neuroectodermal Tumors, Primitive, Peripheral'}, {'id': 'D018242', 'term': 'Neuroectodermal Tumors, Primitive'}, {'id': 'D018302', 'term': 'Neoplasms, Neuroepithelial'}, {'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': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D057832', 'term': 'Watchful Waiting'}], 'ancestors': [{'id': 'D017063', 'term': 'Outcome Assessment, Health Care'}, {'id': 'D010043', 'term': 'Outcome and Process Assessment, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'primaryPurpose': 'SUPPORTIVE_CARE'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 140}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2004-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-05', 'lastUpdateSubmitDate': '2013-09-19', 'studyFirstSubmitDate': '2006-12-27', 'studyFirstSubmitQcDate': '2006-12-27', 'lastUpdatePostDateStruct': {'date': '2013-09-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-12-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety and efficacy'}], 'secondaryOutcomes': [{'measure': 'Predictive factors of relapse and survival'}]}, 'conditionsModule': {'keywords': ['long-term effects secondary to cancer therapy in children', 'localized resectable neuroblastoma', 'localized unresectable neuroblastoma', 'regional neuroblastoma'], 'conditions': ['Long-term Effects Secondary to Cancer Therapy in Children', 'Neuroblastoma']}, 'descriptionModule': {'briefSummary': "RATIONALE: Observation is closely monitoring a patient's condition and not giving treatment until symptoms appear or change. Observation may help doctors see how effective surgery is in treating neuroblastoma.\n\nPURPOSE: This phase II trial is studying how well surgery alone works in treating young patients with localized neuroblastoma.", 'detailedDescription': 'OBJECTIVES:\n\nPrimary\n\n* Evaluate the safety and efficacy of surgical treatment alone in young patients with stage 2 neuroblastoma without N-myc amplification (NMA).\n\nSecondary\n\n* Determine predictive factors of relapse and survival of patients with stage 1, 2A, or 2B neuroblastoma without NMA who have undergone surgery only.\n\nOUTLINE: This is a nonrandomized, multicenter study.\n\nPatients with stage 1 or 2 disease and no N-myc amplification (NMA) undergo observation comprising clinical evaluation, ultrasound or CT scan of the abdomen, and chest x-ray periodically for up to 5 years. All other patients undergo additional therapy and follow-up according to national standards. Patients who develop recurrent disease or disease progression may undergo surgical resection, preceded or followed by chemotherapy, according to national standards.\n\nPROJECTED ACCRUAL: A total of 140 patients will be accrued for this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically confirmed neuroblastoma or ganglioneuroblastoma\n* Meets 1 of the following International Neuroblastoma Staging System (INSS) criteria:\n\n * Stage 1\n * Stage 2A or 2B meeting 1 of the following criteria:\n\n * With or without N-myc amplification\n * No evaluation of NMA\n * Symptomatic spinal cord compression\n * Stage 3\\*\n * Dumbbell syndrome with clinical signs of spinal cord compression\\*\n* NOTE: \\*These patients are eligible for the study but do not undergo observation; instead they will undergo standard treatment\n* Has undergone complete or gross surgical resection OR diagnostic surgical or needle biopsy\n* No metastases within 1 month of diagnosis\n\n * No skin metastases by clinical examination and MIBG scan\n * Normal liver by CT scan or ultrasonography\n * Normal chest X-ray (in case of nonthoracic primary site)\n\nPATIENT CHARACTERISTICS:\n\n* Not specified\n\nPRIOR CONCURRENT THERAPY:\n\n* See Disease Characteristics\n* Prior steroids allowed\n* No prior chemotherapy'}, 'identificationModule': {'nctId': 'NCT00416559', 'briefTitle': 'Observation of Young Patients With Localized Neuroblastoma Who Have Undergone Surgery Only', 'organization': {'class': 'NIH', 'fullName': 'National Cancer Institute (NCI)'}, 'officialTitle': 'Phase II Trial of Surgery as the Only Treatment for INSS Stage 2A & 2B Neuroblastoma', 'orgStudyIdInfo': {'id': 'CDR0000454574'}, 'secondaryIdInfos': [{'id': 'CCLG-NB-1995-06'}, {'id': 'EU-20596'}, {'id': 'CCLG-94-01'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'clinical observation', 'type': 'OTHER'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Bruno De Bernardi, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Istituto Giannina Gaslini'}, {'name': 'Jean Marie Michon, MD', 'affiliation': 'Institut Curie'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Children's Cancer and Leukaemia Group", 'class': 'OTHER'}}}}