Trial Comparing Two Carboplatin Doses in Groups C and D Intraocular Retinoblastoma

NCT00889018 | Unknown

• 1 other identifier: RACHNAMEEL
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Intraocular Retinoblastoma

Keywords

intraocular retinoblastoma; chemotherapy

Outcome Measures

Primary Outcomes (1)

• 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

  1 year

Secondary Outcomes (1)

• 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

  1 year

Study Arms (2)

group 1

ACTIVE COMPARATOR

chemotherapy using carboplatin 560mg/m2

Drug: carboplatin

group 2

EXPERIMENTAL

chemotherapy using 750mg/m2 carboplatin

Drug: carboplatin

Interventions

carboplatin DRUG

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). .

Also known as: paraplatin

group 1

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Biomicroscopic evidence of iris neovascularization
• Neovascular glaucoma
• Tumor invasion into the anterior chamber, iris, optic nerve, choroid, or extraocular tissues as documented by clinical, ultrasonographic, and neuroimaging modalities.
• evidence of systemic metastasis
• prior chemotherapy
• prior treatment for retinoblastoma, or
• inadequate renal or hepatic function

Sponsors & Collaborators

• All India Institute of Medical Sciences: lead
• Council of Scientific and Industrial Research, India: collaborator

Study Sites (1)

Dr RPC AIIMS

Delhi, National Capital Territory of Delhi, 110029, India

Location

Related Publications (1)

• 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.

  PMID: 25439612 DERIVED

MeSH Terms

Interventions

Carboplatin

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals

Study Officials

• Rachna Meel, MS Ophthal

  Dr RPC, AIIMS

  PRINCIPAL INVESTIGATOR

• Supriyo Ghose, MS Ophthal

  Prof and HOD, Dr RPC, AIIMS

  STUDY CHAIR

• Sameer Bakhshi, MD Paeds

  Associate Prof., IRCH, AIIMS

  STUDY CHAIR

• Neelam Pushker, MD Ophthal

  Associate Prof., Dr RPC, AIIMS

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Research Associate

Study Record Dates

• First Submitted: April 27, 2009
• First Posted: April 28, 2009
• Study Start: April 1, 2009
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: February 9, 2012

Record last verified: 2012-02

Locations

IN (1)