Ignite Creation Date:
2025-12-24 @ 4:53 PM
Ignite Modification Date:
2026-02-23 @ 9:23 PM
Study NCT ID:
NCT00360750
Status:
UNKNOWN
Last Update Posted:
2013-09-17
First Post:
2006-08-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Chemotherapy With or Without Radiation Therapy or Observation in Treating Young Patients With Advanced Retinoblastoma Who Have Undergone Surgery to Remove the Eye
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Ireland']}, 'conditionBrowseModule': {'meshes': [{'id': 'D012175', 'term': 'Retinoblastoma'}], 'ancestors': [{'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'}, {'id': 'D019572', 'term': 'Retinal Neoplasms'}, {'id': 'D005134', 'term': 'Eye Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D015785', 'term': 'Eye Diseases, Hereditary'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D012164', 'term': 'Retinal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016190', 'term': 'Carboplatin'}, {'id': 'D003561', 'term': 'Cytarabine'}, {'id': 'D005047', 'term': 'Etoposide'}, {'id': 'D014750', 'term': 'Vincristine'}, {'id': 'D057832', 'term': 'Watchful Waiting'}, {'id': 'D017024', 'term': 'Chemotherapy, Adjuvant'}, {'id': 'D011878', 'term': 'Radiotherapy'}], 'ancestors': [{'id': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D001087', 'term': 'Arabinonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D011034', 'term': 'Podophyllotoxin'}, {'id': 'D013764', 'term': 'Tetrahydronaphthalenes'}, {'id': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D005960', 'term': 'Glucosides'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D014748', 'term': 'Vinca Alkaloids'}, {'id': 'D046948', 'term': 'Secologanin Tryptamine Alkaloids'}, {'id': 'D026121', 'term': 'Indole Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D054836', 'term': 'Indolizidines'}, {'id': 'D007212', 'term': 'Indolizines'}, {'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'}, {'id': 'D003131', 'term': 'Combined Modality Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D004358', 'term': 'Drug Therapy'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT'}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2005-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-06', 'lastUpdateSubmitDate': '2013-09-16', 'studyFirstSubmitDate': '2006-08-03', 'studyFirstSubmitQcDate': '2006-08-03', 'lastUpdatePostDateStruct': {'date': '2013-09-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-08-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Outcome data compared to historical controls'}, {'measure': 'Disease-free and overall survival in children undergoing observation after enucleation'}, {'measure': 'Toxicity'}]}, 'conditionsModule': {'keywords': ['intraocular retinoblastoma', 'extraocular retinoblastoma'], 'conditions': ['Retinoblastoma']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Drugs used in chemotherapy, such as carboplatin, vincristine, etoposide, and cytarabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving chemotherapy with or without radiation therapy after surgery may kill any tumor cells that remain after surgery. Sometimes, after surgery, the tumor does not need more treatment until it progresses. In this case, observation may be sufficient.\n\nPURPOSE: This clinical trial is studying how well chemotherapy with or without radiation therapy or observation works in treating young patients with advanced retinoblastoma who have undergone surgery to remove the eye.', 'detailedDescription': 'OBJECTIVES:\n\n* Compare outcome data in children with advanced unilateral retinoblastoma with historical controls in order to determine whether post-enucleation chemotherapy with or without radiotherapy improves outcome.\n* Determine the disease-free and overall survival of children with unilateral retinoblastoma with no adverse histological features who undergo observation after enucleation.\n* Determine the toxicity of these regimens in these patients.\n\nOUTLINE: This is a nonrandomized study. Patients are assigned to 1 of 3 treatment groups according to histological features.\n\n* Group 1 (no adverse histological features): Patients are observed and monitored for the development of orbital recurrence and metastatic disease.\n* Group 2a (deep choroidal invasion and/or retrolaminar invasion of the optic nerve and disease in the anterior chamber): Patients receive carboplatin IV over 1 hour, vincristine IV, and etoposide IV over 4 hours on day 1, and, if necessary, intrathecal cytarabine on day 2. Treatment repeats every 21 days for 4 courses.\n* Group 2b (invasion of the cut end of the optic nerve): Patients receive carboplatin IV over 1 hour, vincristine IV, and etoposide IV over 4 hours on day 1, and, if necessary, intrathecal cytarabine on day 2. Treatment repeats every 21 days for 6 courses. Patients also undergo orbital radiotherapy 5 days a week for 4 weeks.\n\nAfter completion of study treatment, patients are followed periodically for up to 10 years.\n\nPROJECTED ACCRUAL: Not specified'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '15 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically confirmed unilateral retinoblastoma\n\n * Prior primary enucleation required\n* No metastatic spread\n\nPATIENT CHARACTERISTICS:\n\n* Not specified\n\nPRIOR CONCURRENT THERAPY:\n\n* See Disease Characteristics\n* No prior chemotherapy\n* No concurrent steroids as antiemetic agents'}, 'identificationModule': {'nctId': 'NCT00360750', 'briefTitle': 'Chemotherapy With or Without Radiation Therapy or Observation in Treating Young Patients With Advanced Retinoblastoma Who Have Undergone Surgery to Remove the Eye', 'organization': {'class': 'NIH', 'fullName': 'National Cancer Institute (NCI)'}, 'officialTitle': 'A Data Collection Study to Compare the Outcome for Children With Advanced Unilateral Retinoblastoma Treated With or Without Post-Enucleation Chemotherapy ± Radiotherapy on RB 2005 11 With Historical Controls Receiving no Additional Therapy', 'orgStudyIdInfo': {'id': 'CDR0000481598'}, 'secondaryIdInfos': [{'id': 'CCLG-RB-2005-11'}, {'id': 'EU-20616'}, {'id': 'EUDRACT-2004-001367-21'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'carboplatin', 'type': 'DRUG'}, {'name': 'cytarabine', 'type': 'DRUG'}, {'name': 'etoposide', 'type': 'DRUG'}, {'name': 'vincristine sulfate', 'type': 'DRUG'}, {'name': 'clinical observation', 'type': 'OTHER'}, {'name': 'adjuvant therapy', 'type': 'PROCEDURE'}, {'name': 'radiation therapy', 'type': 'RADIATION'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'B4 6NH', 'city': 'Birmingham', 'state': 'England', 'country': 'United Kingdom', 'facility': "Birmingham Children's Hospital", 'geoPoint': {'lat': 52.48142, 'lon': -1.89983}}, {'zip': 'BS2 8AE', 'city': 'Bristol', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Institute of Child Health at University of Bristol', 'geoPoint': {'lat': 51.45523, 'lon': -2.59665}}, {'zip': 'CB2 2QQ', 'city': 'Cambridge', 'state': 'England', 'country': 'United Kingdom', 'facility': "Addenbrooke's Hospital", 'geoPoint': {'lat': 52.2, 'lon': 0.11667}}, {'zip': 'LS9 7TF', 'city': 'Leeds', 'state': 'England', 'country': 'United Kingdom', 'facility': "Leeds Cancer Centre at St. James's University Hospital", 'geoPoint': {'lat': 53.79648, 'lon': -1.54785}}, {'zip': 'LE1 5WW', 'city': 'Leicester', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Leicester Royal Infirmary', 'geoPoint': {'lat': 52.6386, 'lon': -1.13169}}, {'zip': 'WC1N 3JH', 'city': 'London', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Great Ormond Street Hospital for Children', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'M27 4HA', 'city': 'Manchester', 'state': 'England', 'country': 'United Kingdom', 'facility': "Royal Manchester Children's Hospital", 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}, {'zip': 'NG7 2UH', 'city': 'Nottingham', 'state': 'England', 'country': 'United Kingdom', 'facility': "Queen's Medical Centre", 'geoPoint': {'lat': 52.9536, 'lon': -1.15047}}, {'zip': 'S10 2TH', 'city': 'Sheffield', 'state': 'England', 'country': 'United Kingdom', 'facility': "Children's Hospital - Sheffield", 'geoPoint': {'lat': 53.38297, 'lon': -1.4659}}, {'zip': 'SO16 6YD', 'city': 'Southampton', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Southampton General Hospital', 'geoPoint': {'lat': 50.90395, 'lon': -1.40428}}, {'zip': 'BT12 6BE', 'city': 'Belfast', 'state': 'Northern Ireland', 'country': 'United Kingdom', 'facility': 'Royal Belfast Hospital for Sick Children', 'geoPoint': {'lat': 54.59682, 'lon': -5.92541}}, {'zip': 'EH9 1LF', 'city': 'Edinburgh', 'state': 'Scotland', 'country': 'United Kingdom', 'facility': 'Royal Hospital for Sick Children', 'geoPoint': {'lat': 55.95206, 'lon': -3.19648}}, {'zip': 'G3 8SJ', 'city': 'Glasgow', 'state': 'Scotland', 'country': 'United Kingdom', 'facility': 'Royal Hospital for Sick Children', 'geoPoint': {'lat': 55.86515, 'lon': -4.25763}}], 'overallOfficials': [{'name': 'Helen Jenkinson, MD', 'role': 'STUDY_CHAIR', 'affiliation': "Birmingham Children's Hospital"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Children's Cancer and Leukaemia Group", 'class': 'OTHER'}}}}