NCT00072384|CompletedPhase 3ResultsDMC

Systemic Chemotherapy and Subtenon Carboplatin, and Local Ophthalmic Therapy in Children With Intraocular Retinoblastoma

A Single Arm Trial of Systemic And Subtenon Chemotherapy For Groups C And D Intraocular Retinoblastoma

Children's Oncology Group ClinicalTrials.gov

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5 other identifiers

ARET0231NCI-2009-00420CDR0000339627COG-ARET0231U10CA098543

Study Type

interventional

Target

Locations

1 country

Sites

Timeline

RegisteredNov 2003

StartedApr 2007

CompletionJun 2021

Brief Summary

Phase III trial to determine the effectiveness of combining systemic chemotherapy and subtenon carboplatin with ophthalmic therapy in treating children who have intraocular retinoblastoma. Drugs used in chemotherapy, such as vincristine, carboplatin, and etoposide, work in different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether systemic chemotherapy and subtenon (under the conjunctiva of the eye) carboplatin combined with ophthalmic therapy is effective in treating intraocular (within the eyeball) 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 Apr 2007

Longer than P75 for phase_3

Geographic Reach

1 country

11 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

14.2 years study duration

First Submitted

Initial submission to the registry

November 4, 2003

Completed

2 days until next milestone

First Posted

Study publicly available on registry

November 6, 2003

Completed

3.4 years until next milestone

Study Start

First participant enrolled

April 16, 2007

Completed

5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed

5.6 years until next milestone

Results Posted

Study results publicly available

September 19, 2018

Completed

2.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2021

Completed

Last Updated

July 30, 2021

Status Verified

July 1, 2021

Enrollment Period

5.8 years

First QC Date

November 4, 2003

Results QC Date

November 25, 2015

Last Update Submit

July 12, 2021

Conditions

Intraocular Retinoblastoma

Outcome Measures

Primary Outcomes (2)

Group D Eyes - Treatment Failure Within One Year
Each Group D eye will be classified as experiencing failure within one year after start of treatment: yes or no. The method of Rosner et al. (Biometrics v. 38, 105-114, 1982) will be used to model possible dependence between eyes from the same patient. The point estimate of the probability of treatment failure is reported as the "Mean" measure type.
One year
Group C Eyes - Treatment Failure Within One Year
Each Group C eye will be classified as experiencing failure within one year after start of treatment: yes or no. The method of Rosner et al. (Biometrics v. 38, 105-114, 1982) will be used to model possible dependence between eyes from the same patient. The point estimate of the probability of treatment failure is reported as the "Mean" measure type.
One year

Secondary Outcomes (4)

Event-free Survival (EFS)
One year after study enrollment
Toxicity Associated With Chemotherapy
From date of enrollment until termination of protocol therapy assessed up to 72 weeks
Patterns of Failure for Group C and Group D in Terms of Vitreous vs Patterns of Failure for Group C and Group D in Terms of Vitreous vs Retinal vs Both as Sites of Recurrence
From the date of enrollment assessed up to 36 months
Patterns of Treatment Failure vs. no Treatment Failure for Group C Eyes and Group D Eyes According to Initial Sites of Involvement
From the date of enrollment assessed up to 12 months

Study Arms (1)

Treatment (chemotherapy, surgery)

EXPERIMENTAL

Patients receive liposomal vincristine sulfate IV over 1 minute on day 1 and carboplatin IV over 1 hour and etoposide IV over 1 hour on days 1 and 2. Patients also receive filgrastim (G-CSF) subcutaneously daily beginning on day 3 and continuing until blood counts recover. Patients receive subtenon carboplatin to each group C or D eye on day 0 or 1prior of courses 2-4 only. Treatment repeats every 28 days for 6 courses in the absence of occurrence of extraocular retinoblastoma or a second malignancy. Beginning with course 3 of systemic chemotherapy, patients undergo local ophthalmic therapy comprising local laser surgery and/or cryosurgery on day 1.

Drug: liposomal vincristine sulfateProcedure: cryosurgeryProcedure: laser surgeryDrug: carboplatinDrug: etoposideBiological: filgrastim

Interventions

liposomal vincristine sulfateDRUG

Given IV

Also known as: liposomal vincristine, Marqibo, vincristine liposomal, vincristine sulfate liposome injection