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NCT00335738 · ClinicalTrials.gov registry record · Phase 3

Vincristine, Carboplatin, and Etoposide or Observation Only in Treating Patients Who Have Undergone Surgery for Newly Diagnosed Retinoblastoma

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

Completed
Registry status
Phase 3
Development phase
331
Enrollment target

NCT00335738: Completed Phase 3 study, sponsored by Children's Oncology Group.

NCT00335738 is a Phase 3 study that has completed, run by Children's Oncology Group. The registered enrollment target is 331 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (57% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00335738, a Phase 3 study, has completed, sponsored by Children's Oncology Group.

COMPLETED
Registry status
Phase 3
Development phase
331 participants
Enrollment target

Study Summary

This phase III trial is studying vincristine, carboplatin, and etoposide to see how well they work compared to observation only in treating patients who have undergone surgery for newly diagnosed retinoblastoma. Drugs used in chemotherapy, such as vincristine, carboplatin, and etoposide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) after surgery may kill any tumor cells that remain after surgery. Sometimes, after surgery, no additional treatment is needed for the tumor until it progresses. In this case, observation may be sufficient.

Primary Outcome

EFS distributions will be estimated by the Kaplan-Meier method for patients with high risk features according to central review and treated with adjuvant chemotherapy and separately for subjects with central review recommendation of enucleation alone.

Interventions

  • DRUG carboplatin
  • DRUG etoposide
  • DRUG liposomal vincristine sulfate

Trial Details

FieldValue
Enrollment Target 331 participants
Start Date 2005-12
Est. Completion 2020-09-30
Phase Phase 3
Children's Oncology Group

342 total trials

What the finished NCT00335738 record still lists

NCT00335738 is an interventional study that assigns participants to a tested intervention. The registered 331 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (57% lower).

The record links to 0 conditions, and to 3 interventions - of which carboplatin is the first listed.

NCT00335738 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00335738 about?

NCT00335738 is a clinical study titled "Vincristine, Carboplatin, and Etoposide or Observation Only in Treating Patients Who Have Undergone Surgery for Newly Diagnosed Retinoblastoma". This phase III trial is studying vincristine, carboplatin, and etoposide to see how well they work compared to observation only in treating patients who have undergone surgery for newly diagnosed retinoblastoma. Drugs used in chemotherapy, such as vincristine, carboplatin, and etoposide, work in dif...

What is the current status of trial NCT00335738?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 331 participants. The study started on 2005-12. Estimated completion is 2020-09-30.

What interventions are being tested in trial NCT00335738?

The interventions under investigation include: carboplatin (DRUG), etoposide (DRUG), liposomal vincristine sulfate (DRUG).

Who is sponsoring clinical trial NCT00335738?

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

How this trial's enrollment target compares

Where NCT00335738's enrollment target sits among peer trials

331 1066th of 2000 higher than 935 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 NCT00335738, the US trial registry maintained by the National Library of Medicine. NCT00335738 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.