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

NCT00889018 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2012-02-09

No results posted yet for this study

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

Interventions

DRUG

carboplatin

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). .

DRUG

carboplatin

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).

Sponsors & Collaborators

  • Council of Scientific and Industrial Research, India

    collaborator OTHER_GOV

  • All India Institute of Medical Sciences

    lead OTHER

Principal Investigators

  • Rachna Meel, MS Ophthal · Dr RPC, AIIMS

  • Supriyo Ghose, MS Ophthal · Prof and HOD, Dr RPC, AIIMS

  • Sameer Bakhshi, MD Paeds · Associate Prof., IRCH, AIIMS

  • Neelam Pushker, MD Ophthal · Associate Prof., Dr RPC, AIIMS

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-04-30
Primary Completion
2012-04-30
Completion
2012-04-30

Countries

  • India

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00889018 on ClinicalTrials.gov