Ignite Creation Date:
2025-12-25 @ 4:58 AM
Ignite Modification Date:
2025-12-26 @ 3:58 AM
Study NCT ID:
NCT00889018
Status:
UNKNOWN
Last Update Posted:
2012-02-09
First Post:
2009-04-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Trial Comparing Two Carboplatin Doses in Groups C and D Intraocular Retinoblastoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D016190', 'term': 'Carboplatin'}], 'ancestors': [{'id': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2009-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-02', 'completionDateStruct': {'date': '2012-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-02-07', 'studyFirstSubmitDate': '2009-04-27', 'studyFirstSubmitQcDate': '2009-04-27', 'lastUpdatePostDateStruct': {'date': '2012-02-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-04-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ocular salvage rates in two randomly divided groups of group C and D retinoblastomas, treated with primary chemotherapy protocol using 560mg/m2 carboplatin and 750mg/m2 carboplatin respectively', 'timeFrame': '1 year'}], 'secondaryOutcomes': [{'measure': 'To evaluate the response of subtenon carboplatin injections in cases of group C and D retinoblastomas that fail to respond to primary chemotherapy and local treatment', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['intraocular retinoblastoma', 'chemotherapy'], 'conditions': ['Intraocular Retinoblastoma']}, 'referencesModule': {'references': [{'pmid': '25439612', 'type': 'DERIVED', 'citation': 'Meel R, Bakhshi S, Pushker N, Vishnubhatla S. Randomized, controlled trial in groups C and D retinoblastoma. Ophthalmology. 2015 Feb;122(2):433-5. doi: 10.1016/j.ophtha.2014.09.013. Epub 2014 Oct 22. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether an increase in the dose of carboplatin in treatment of advanced intraocular (group C and D) retinoblastoma helps in avoiding radiotherapy and improves the rate of globe salvage.', 'detailedDescription': "Chemoreduction has become an important method in management of retinoblastoma. This technique has been employed in an effort to avoid enucleation and external beam radiotherapy (EBRT) for children with intraocular retinoblastoma, especially those with bilateral disease. Although an ideal regimen for chemoreduction has not been determined, most authors use a combination of vincristine, etoposide and carboplatin for 2- 6 cycles along with local treatment including cryotherapy, laser photocoagulation, thermotherapy and plaque radiotherapy. Chemoreduction along with local treatment has been shown to have high treatment success in groups A and B of retinoblastoma allowing globe salvage without need of EBRT. But globe salvage rates remain low in groups C and D, which mostly need enucleation, or EBRT in a large number of cases.\n\nIn bilateral retinoblastoma where one eye is already lost owing to enucleation or both the eyes have advanced retinoblastoma (group C/D) globe salvage assumes a significant role in the overall treatment. Recurrences of the vitreous seeds or the sub retinal seeds are the main causes of treatment failure with chemoreduction and local treatment, ultimately requiring enucleation or EBRT.\n\nThe recurrence of vitreous or subretinal seeds do not necessarily mean a tumor resistance, it may reflect an inadequate penetration of the chemotherapeutic agents in these relatively avascular sites i.e the vitreous cavity or the subretinal space.\n\nThe penetration to these sites could be enhanced by (a) increase in the dose of the intravenous chemotherapeutic agents. The IInd Toronto protocol that was started in 2000 explores this option. The initial reports are encouraging but they have used high doses chemotherapy in combination with cyclosporin A. Therefore the effect of high dose chemotherapy on the globe salvage rates in groups C and D cannot be evaluated as an independent factor. (b) Periocular carboplatin injection has proven to deliver much higher levels of the drug in to the vitreous cavity, but several studies have revealed local side effects of this apparently harmless technique.The National Collaborative Retinoblastoma Study funded by the Children's oncology group plans to carry out a single arm trial of 6 cycles of systemic high dose chemotherapy and subtenon carboplatin injections in groups C and D of retinoblastoma. (c) Use of Cryotherapy/thermotherapy along with chemotherapy, has shown to increase the penetration of the chemotherapeutic agents into the vitreous cavity probably by disrupting the blood retinal barrier.\n\nShield's et al has already shown that the 6 cycle chemotherapy regimen achieves better long-term control of vitreous and subretinal seeds as compared to a 2 cycle regimen.\n\nWe planned this study to compare two different dose schedules of carboplatin and compare the rate of globe salvage in group C and D retinoblastoma and also to evaluate the effect of subtenon Carboplatin injections in cases that fail to respond to primary chemotherapy."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All new cases of retinoblastoma with group C or D tumor as per the ICRB (International classification of retinoblastoma, Table 2) that present at Rajendra Prasad Centre for Ophthalmic Sciences over first 2 years of the study period\n\nExclusion Criteria:\n\n* Biomicroscopic evidence of iris neovascularization\n* Neovascular glaucoma\n* Tumor invasion into the anterior chamber, iris, optic nerve, choroid, or extraocular tissues as documented by clinical, ultrasonographic, and neuroimaging modalities.\n* Systemic exclusion criteria include:\n\n * evidence of systemic metastasis\n * prior chemotherapy\n * prior treatment for retinoblastoma, or\n * inadequate renal or hepatic function'}, 'identificationModule': {'nctId': 'NCT00889018', 'briefTitle': 'Trial Comparing Two Carboplatin Doses in Groups C and D Intraocular Retinoblastoma', 'organization': {'class': 'OTHER', 'fullName': 'All India Institute of Medical Sciences'}, 'officialTitle': 'Randomized Control Trial Comparing Carboplatin 560mg/m2 With 750mg/m2 for Ocular Salvage in Groups C and D Intraocular Retinoblastoma', 'orgStudyIdInfo': {'id': 'RACHNAMEEL'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'group 1', 'description': 'chemotherapy using carboplatin 560mg/m2', 'interventionNames': ['Drug: carboplatin']}, {'type': 'EXPERIMENTAL', 'label': 'group 2', 'description': 'chemotherapy using 750mg/m2 carboplatin', 'interventionNames': ['Drug: carboplatin']}], 'interventions': [{'name': 'carboplatin', 'type': 'DRUG', 'otherNames': ['paraplatin'], 'description': 'Table. 1: Chemotherapy protocol Vincristine Etoposide Carboplatin Day1 + + + Day2 ---- + ---- This regimen is repeated once a month for 6 months.Dose:Vincristine: 1.5 mg/m2 (0.05 mg/kg for children £36 months old and maximum dose 2 mg).Etoposide: 150 mg/m2 (5 mg/kg for children £36 months old).Carboplatin: 560 mg/m2 (18.6 mg/kg for children £36 months old). .', 'armGroupLabels': ['group 1']}, {'name': 'carboplatin', 'type': 'DRUG', 'otherNames': ['paraplatin'], 'description': 'Table. 1: Chemotherapy protocol Vincristine Etoposide Carboplatin Day1 + + + Day2 ---- + ---- This regimen is repeated once a month for 6 months.Dose:Vincristine: 1.5 mg/m2 (0.05 mg/kg for children £36 months old and maximum dose 2 mg).Etoposide: 150 mg/m2 (5 mg/kg for children £36 months old).Carboplatin: 750 mg/m2 (25 mg/kg for children £36 months old).', 'armGroupLabels': ['group 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '110029', 'city': 'Delhi', 'state': 'National Capital Territory of Delhi', 'country': 'India', 'facility': 'Dr RPC AIIMS', 'geoPoint': {'lat': 28.65195, 'lon': 77.23149}}], 'overallOfficials': [{'name': 'Rachna Meel, MS Ophthal', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dr RPC, AIIMS'}, {'name': 'Supriyo Ghose, MS Ophthal', 'role': 'STUDY_CHAIR', 'affiliation': 'Prof and HOD, Dr RPC, AIIMS'}, {'name': 'Sameer Bakhshi, MD Paeds', 'role': 'STUDY_CHAIR', 'affiliation': 'Associate Prof., IRCH, AIIMS'}, {'name': 'Neelam Pushker, MD Ophthal', 'role': 'STUDY_CHAIR', 'affiliation': 'Associate Prof., Dr RPC, AIIMS'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'All India Institute of Medical Sciences', 'class': 'OTHER'}, 'collaborators': [{'name': 'Council of Scientific and Industrial Research, India', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Senior Research Associate', 'investigatorFullName': 'Rachna Meel', 'investigatorAffiliation': 'All India Institute of Medical Sciences'}}}}