Trial Information

A Data Collection Study to Compare the Outcome for Children With Advanced Unilateral Retinoblastoma Treated With or Without Post-Enucleation Chemotherapy ± Radiotherapy on RB 2005 11 With Historical Controls Receiving no Additional Therapy

OBJECTIVES:

- Compare outcome data in children with advanced unilateral retinoblastoma with
historical controls in order to determine whether post-enucleation chemotherapy with or
without radiotherapy improves outcome.

- Determine the disease-free and overall survival of children with unilateral
retinoblastoma with no adverse histological features who undergo observation after
enucleation.

- Determine the toxicity of these regimens in these patients.

OUTLINE: This is a nonrandomized study. Patients are assigned to 1 of 3 treatment groups
according to histological features.

- Group 1 (no adverse histological features): Patients are observed and monitored for the
development of orbital recurrence and metastatic disease.

- Group 2a (deep choroidal invasion and/or retrolaminar invasion of the optic nerve and
disease in the anterior chamber): Patients receive carboplatin IV over 1 hour,
vincristine IV, and etoposide IV over 4 hours on day 1, and, if necessary, intrathecal
cytarabine on day 2. Treatment repeats every 21 days for 4 courses.

- Group 2b (invasion of the cut end of the optic nerve): Patients receive carboplatin IV
over 1 hour, vincristine IV, and etoposide IV over 4 hours on day 1, and, if necessary,
intrathecal cytarabine on day 2. Treatment repeats every 21 days for 6 courses.
Patients also undergo orbital radiotherapy 5 days a week for 4 weeks.

After completion of study treatment, patients are followed periodically for up to 10 years.

PROJECTED ACCRUAL: Not specified