Trial of Systemic Neoadjuvant Chemotherapy for Group B Intraocular Retinoblastoma
I. Determine the 2-year event-free survival of patients with Group B intraocular
retinoblastoma treated with neoadjuvant chemoreduction comprising carboplatin and
vincristine and standardized local ophthalmic therapy.
I. Determine the response rate after one course of chemoreduction (before standardized local
ophthalmic therapy) in these patients.
II. Correlate response rate with event-free survival in patients treated with this regimen.
III. Determine the incidence of toxic effects in patients treated with this regimen.
OUTLINE: This is a multicenter study.
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
Patients are followed every 3-4 weeks until there is no active tumor seen on a minimum of 3
ophthalmic exams under anesthesia, every 6-8 weeks until 3 years of age, every 4-6 months
until 10 years of age, and then annually thereafter.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Observed survival experience to the expected distribution using a method adapted from Woolson will be used. The difference between the number of observed and expected failures is approximately normally distributed with independent increments and may be used for interim monitoring using standard group sequential boundaries. Outcome data will be formally reviewed, using the Lan-DeMets α-spending function implementation of sequential boundaries, after every expected failure, corresponding approximately to 33%, 66% and 100% of the expected information.
At 2 years
Children's Oncology Group
United States: Institutional Review Board
|Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium||Seattle, Washington 98109|
|Children's Oncology Group||Arcadia, California 91006-3776|