Clinical Trial: Trial Comparing Two Carboplatin Doses in Groups C and D Intraocular Retinoblastoma
Study Status: Terminated
Recruit Status: Unknown status
Study Type: Interventional
Official Title: Randomized Control Trial Comparing Carboplatin 560mg/m2 With 750mg/m2 for Ocular Salvage in Groups C and D Intraocular Retinoblastoma
Brief Summary: 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.
Detailed Summary:
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.
In 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.
The 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.
The 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
Sponsor: All India Institute of Medical Sciences, New Delhi
Current Primary Outcome: 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 [ Time Frame: 1 year ]
Original Primary Outcome: Same as current
Current Secondary Outcome: 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 [ Time Frame: 1 year ]
Original Secondary Outcome: Same as current
Information By: All India Institute of Medical Sciences, New Delhi
Dates:
Date Received: April 27, 2009
Date Started: April 2009
Date Completion: April 2012
Last Updated: February 7, 2012
Last Verified: February 2012
