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NCT00025259 · ClinicalTrials.gov registry record · Phase 3

Chemotherapy With or Without Additional Chemotherapy and/or Radiation Therapy in Treating Children With Newly Diagnosed Hodgkin's Disease

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

Completed
Registry status
Phase 3
Development phase
1,734
Enrollment target

NCT00025259: Completed Phase 3 study, sponsored by Children's Oncology Group.

NCT00025259 is a Phase 3 study that has completed, run by Children's Oncology Group. The registered enrollment target is 1,734 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (125% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00025259, a Phase 3 study, has completed, sponsored by Children's Oncology Group.

COMPLETED
Registry status
Phase 3
Development phase
1,734 participants
Enrollment target

Study Summary

This randomized phase III trial is studying different chemotherapy regimens given with or without radiation therapy to compare how well they work in treating children with newly diagnosed Hodgkin's disease. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Giving the drugs in different combinations may kill more cancer cells. Radiation therapy uses high-energy x-rays to damage cancer cells. It is not yet known if chemotherapy is more effective with or without additional chemotherapy and/or radiation therapy in treating Hodgkin's disease.

Primary Outcome

Probability of event-Free survival which is defined as the time from study entry to treatment failure (disease progression, disease recurrence, biopsy positive residual after completion of all protocol therapy), occurrence of a second malignant neoplasm, or death from any cause. Patients without report of such events where censored at last contact.

Interventions

  • DRUG Cyclophosphamide
  • DRUG Cisplatin
  • DRUG Dexamethasone
  • BIOLOGICAL Bleomycin Sulfate
  • DRUG Cytarabine

Trial Details

FieldValue
Enrollment Target 1,734 participants
Start Date 2002-09
Phase Phase 3
Children's Oncology Group

342 total trials

What the finished NCT00025259 record still lists

NCT00025259 is an interventional study that assigns participants to a tested intervention. Its 1,734 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (125% higher).

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

NCT00025259 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00025259 about?

NCT00025259 is a clinical study titled "Chemotherapy With or Without Additional Chemotherapy and/or Radiation Therapy in Treating Children With Newly Diagnosed Hodgkin's Disease". This randomized phase III trial is studying different chemotherapy regimens given with or without radiation therapy to compare how well they work in treating children with newly diagnosed Hodgkin's disease. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop...

What is the current status of trial NCT00025259?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,734 participants. The study started on 2002-09.

What interventions are being tested in trial NCT00025259?

The interventions under investigation include: Cyclophosphamide (DRUG), Cisplatin (DRUG), Dexamethasone (DRUG), Bleomycin Sulfate (BIOLOGICAL), Cytarabine (DRUG).

Who is sponsoring clinical trial NCT00025259?

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 NCT00025259's enrollment target sits among peer trials

1,734 130th of 2000 higher than 1,871 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 NCT00025259, the US trial registry maintained by the National Library of Medicine. NCT00025259 (large enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.