CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 28 enrolled
Drug / intervention
Carboplatin +6 moredrug
Likely dose
Carboplatin IV and vincristine sulfate IV (specific doses not stated in interventions or arms)AI-extracted
Key inclusion· 7
  • Newly diagnosed Group B intraocular retinoblastoma in one or both eyes, or Group A in one eye with Group B in the other, or enucleated Group E in one eye with Group B in the remaining eye
  • Confirmed diagnosis by CT/MRI of brain and orbits plus ophthalmologic evaluation under anesthesia within 3 weeks
  • No choroidal or optic nerve invasion past the lamina cribosa
  • No extraocular retinoblastoma on imaging or clinical exam
Key exclusion· 6
  • Prior chemotherapy for any indication
  • Prior radiotherapy for any indication
  • Prior local ophthalmic therapy for retinoblastoma
  • Any other prior therapy for retinoblastoma

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00079417
NCT00079417Phase 3Completed

Trial of Systemic Neoadjuvant Chemotherapy for Group B Intraocular Retinoblastoma

Children's Oncology Group·interventional·Posted Mar 10, 2004·Updated Mar 13, 2023

In Brief

A Phase 3 clinical trial evaluating Carboplatin, Cryosurgery, and 5 other interventions for Intraocular Retinoblastoma. Completed, enrolled 28 participants across 10 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 3CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 10, 2004
Enrollment StartDec 26, 2005
Primary CompletionJan 1, 2010
Study CompletionMar 31, 2017
TodayJul 2, 2026
Enrollment to primary: 4.0 yearsPosted 22.3 years ago

Interventions

Carboplatindrug

Given IV

Cryosurgeryprocedure

Infrared Laser Therapyprocedure

Iodine I-125radiation

Undergo radioactive therapy

Radiation Therapyradiation

Undergo radioactive therapy

Ruthenium Ru-106radiation

Undergo radioactive therapy

Vincristine Sulfatedrug

Given IV