Brief Summary

This phase III trial is studying how well giving carboplatin and vincristine together with standard local ophthalmic therapy works in treating children with intraocular retinoblastoma. Drugs used in chemotherapy, such as carboplatin and vincristine, work in different ways to stop tumor from dividing so they stop growing or die. It is not yet known whether neoadjuvant chemotherapy combined with standard local ophthalmic therapy is effective in treating intraocular retinoblastoma.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at below P25 for phase_3

Timeline

Completed

Started Dec 2005

Longer than P75 for phase_3

Geographic Reach

1 country

10 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

11.3 years study duration

First Submitted

Initial submission to the registry

March 8, 2004

Completed

2 days until next milestone

First Posted

Study publicly available on registry

March 10, 2004

Completed

1.8 years until next milestone

Study Start

First participant enrolled

December 26, 2005

Completed

4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed

4.1 years until next milestone

Results Posted

Study results publicly available

February 14, 2014

Completed

3.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2017

Completed

Last Updated

March 13, 2023

Status Verified

January 1, 2023

Enrollment Period

4 years

First QC Date

March 8, 2004

Results QC Date

December 23, 2013

Last Update Submit

February 14, 2023

Conditions

Intraocular Retinoblastoma

Outcome Measures

Primary Outcomes (1)

Event-free Survival
Proportion of patients with event free survival at 2 years. An event is defined as the need for non-protocol therapy, defined as additional on-protocol chemotherapy, enucleation or external beam radiation, among patients with Group B intraocular tumors with a schedule of neoadjuvant 2-agent (Vincristine/Carboplatin) chemotherapy (chemo-reduction) and standardized local ophthalmic therapy.
At 2 years

Secondary Outcomes (4)

Response Rate (RR) at Patient Level After the First Course of Therapy
1 month after enrollment
Response Rate (RR) at Eye Levels After the First Course of Therapy
1 month after enrollment
Event-free Survival Rate (EFSR) Defined as the Need for Non-protocol Chemotherapy, Enucleation, or EBRT at the Patient Level
2 years after enrollment
Toxicity as Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 3.0
6 months after enrollment

Study Arms (1)

Treatment (chemotherapy, surgery)

EXPERIMENTAL

Patients receive chemoreduction comprising carboplatin IV over 60 minutes followed by vincristine IV over 1-2 minutes on day 1. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. After the first course of chemoreduction, patients undergo standardized local ophthalmic therapy comprising local laser therapy, cryotherapy, and/or radioactive plaque comprising iodine I 125 or ruthenium Ru 106.

Drug: CarboplatinProcedure: CryosurgeryProcedure: Infrared Laser TherapyRadiation: Iodine I-125Radiation: Radiation TherapyRadiation: Ruthenium Ru-106Drug: Vincristine Sulfate

Interventions

CarboplatinDRUG

Given IV

Also known as: Blastocarb, Carboplat, Carboplatin Hexal, Carboplatino, Carboplatinum, Carbosin, Carbosol, Carbotec, CBDCA, Displata, Ercar, JM-8, Nealorin, Novoplatinum, Paraplatin, Paraplatin AQ, Paraplatine, Platinwas, Ribocarbo