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NCT00079417 · ClinicalTrials.gov registry record · Phase 3

Neoadjuvant Carboplatin and Vincristine and Standard Local Ophthalmic Therapy in Treating Patients With Intraocular Retinoblastoma

A Phase 3 study of Intraocular Retinoblastoma, sponsored by Children's Oncology Group.

Completed
Registry status
Phase 3
Development phase
28
Enrollment target
10
Study locations

NCT00079417: Completed Phase 3 study of Intraocular Retinoblastoma, sponsored by Children's Oncology Group.

NCT00079417 is a Phase 3 study of Intraocular Retinoblastoma that has completed, run by Children's Oncology Group. The registered enrollment target is 28 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (96% lower). The trial reports 10 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00079417, a Phase 3 study of Intraocular Retinoblastoma, has completed, sponsored by Children's Oncology Group.

COMPLETED
Registry status
Phase 3
Development phase
28 participants
Enrollment target
10
Study locations

Study 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.

Primary Outcome

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.

Conditions Studied

Interventions

  • DRUG Carboplatin
  • RADIATION Radiation Therapy
  • PROCEDURE Cryosurgery
  • PROCEDURE Infrared Laser Therapy
  • RADIATION Iodine I-125

Study Locations (10)

Pennsylvania

  • Children's Hospital of Philadelphia - Philadelphia
  • Children's Oncology Group - Philadelphia

California

  • Children's Hospital Los Angeles - Los Angeles

Illinois

  • Lurie Children's Hospital-Chicago - Chicago

Massachusetts

  • Dana-Farber Cancer Institute - Boston

Michigan

  • Wayne State University/Karmanos Cancer Institute - Detroit

North Carolina

  • Duke University Medical Center - Durham

Ohio

  • Cincinnati Children's Hospital Medical Center - Cincinnati

Texas

  • Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center - Houston

Trial Details

FieldValue
Enrollment Target 28 participants
Start Date 2005-12-26
Est. Completion 2017-03-31
Phase Phase 3
Children's Oncology Group

342 total trials

What the finished NCT00079417 record still lists

NCT00079417 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 28 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (96% lower).

The record links to 1 condition, with Intraocular Retinoblastoma appearing as the primary indexed condition, and to 5 interventions - of which Carboplatin is the first listed.

NCT00079417 lists 10 locations in 9 states (Pennsylvania, California, Illinois).

Frequently Asked Questions

What is clinical trial NCT00079417 about?

NCT00079417 is a clinical study titled "Neoadjuvant Carboplatin and Vincristine and Standard Local Ophthalmic Therapy in Treating Patients With Intraocular Retinoblastoma". 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...

What is the current status of trial NCT00079417?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 28 participants. The study started on 2005-12-26. Estimated completion is 2017-03-31.

What conditions does trial NCT00079417 study?

This clinical trial studies the following conditions: Intraocular Retinoblastoma.

What interventions are being tested in trial NCT00079417?

The interventions under investigation include: Carboplatin (DRUG), Radiation Therapy (RADIATION), Cryosurgery (PROCEDURE), Infrared Laser Therapy (PROCEDURE), Iodine I-125 (RADIATION).

Who is sponsoring clinical trial NCT00079417?

This trial is sponsored by Children's Oncology Group, which has 342 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00079417 being conducted?

This trial has 10 study locations across California, Illinois, Massachusetts, Michigan, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Intraocular Retinoblastoma

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT00079417's enrollment target sits among peer trials

28 1935th of 2000 higher than 65 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00079417, the US trial registry maintained by the National Library of Medicine. NCT00079417 (small enrollment · multi site footprint · completed) retrieved and formatted by PlainTrial, see methodology.