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NCT00005578 · ClinicalTrials.gov registry record · Phase 3

Combination Chemotherapy With or Without Dexrazoxane in Treating Children With Hodgkin's Disease

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

Completed
Registry status
Phase 3
Development phase
219
Enrollment target

NCT00005578: Completed Phase 3 study, sponsored by Children's Oncology Group.

NCT00005578 is a Phase 3 study that has completed, run by Children's Oncology Group. The registered enrollment target is 219 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (72% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00005578, a Phase 3 study, has completed, sponsored by Children's Oncology Group.

COMPLETED
Registry status
Phase 3
Development phase
219 participants
Enrollment target

Study Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Chemoprotective drugs, such as dexrazoxane, may protect normal cells from the side effects of chemotherapy. PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy with or without dexrazoxane in treating children who have Hodgkin's disease.

Primary Outcome

The Wilcoxon test will be used to evaluate whether DLCO values differ between the two arms.

Interventions

  • DRUG cyclophosphamide
  • BIOLOGICAL filgrastim
  • DRUG dexrazoxane hydrochloride
  • DRUG doxorubicin hydrochloride
  • BIOLOGICAL bleomycin sulfate

Trial Details

FieldValue
Enrollment Target 219 participants
Start Date 1997-03
Est. Completion 2008-06
Phase Phase 3
Children's Oncology Group

342 total trials

What the finished NCT00005578 record still lists

NCT00005578 is an interventional study that assigns participants to a tested intervention. The registered 219 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 (72% lower).

The record links to 0 conditions, and to 5 interventions - of which cyclophosphamide is the first listed.

NCT00005578 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00005578 about?

NCT00005578 is a clinical study titled "Combination Chemotherapy With or Without Dexrazoxane in Treating Children With Hodgkin's Disease". RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Chemoprotective drugs, such as dexrazoxane, may protect normal cells from the side effects of chemotherapy. PURPOSE: Randomized phase III trial to compare the effectiveness of com...

What is the current status of trial NCT00005578?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 219 participants. The study started on 1997-03. Estimated completion is 2008-06.

What interventions are being tested in trial NCT00005578?

The interventions under investigation include: cyclophosphamide (DRUG), filgrastim (BIOLOGICAL), dexrazoxane hydrochloride (DRUG), doxorubicin hydrochloride (DRUG), bleomycin sulfate (BIOLOGICAL).

Who is sponsoring clinical trial NCT00005578?

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 NCT00005578's enrollment target sits among peer trials

219 1329th of 2000 higher than 670 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 NCT00005578, the US trial registry maintained by the National Library of Medicine. NCT00005578 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.