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NCT01231906 · ClinicalTrials.gov registry record · Phase 3
Combination Chemotherapy in Treating Patients With Non-Metastatic Extracranial Ewing Sarcoma
A Phase 3 study, sponsored by Children's Oncology Group.
- Completed
- Registry status
- Phase 3
- Development phase
- 642
- Enrollment target
NCT01231906: Completed Phase 3 study, sponsored by Children's Oncology Group.
NCT01231906 is a Phase 3 study that has completed, run by Children's Oncology Group. The registered enrollment target is 642 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (17% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01231906, a Phase 3 study, has completed, sponsored by Children's Oncology Group.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 642 participants
- Enrollment target
Study Summary
This trial examined the outcome benefit to patients of adding a new chemotherapy drug combination to the established treatment approach for patients with extracranial Ewing sarcoma, that had not spread from the primary site to other places in the body. The trial randomly assigned patients at the time of study entry to receive established standard treatment with the following 5-drugs: vincristine sulfate, doxorubicin hydrochloride, cyclophosphamide, ifosfamide and etoposide. The outcome for patients receiving the standard 5-drug combination was compared to the outcome for patients who received the same 5-drugs with an additional drug, topotecan hydrochloride delivered in a novel combination with vincristine sulfate and cyclophosphamide.
Primary Outcome
Estimated 5-year EFS where EFS is calculated as the time from study enrollment to disease progression, disease relapse, occurrence of a second malignant neoplasm, death from any cause or last follow-up whichever occurs first. Kaplan-Meier method is used for estimation. Patients without an event are censored at last contact.
Interventions
- DRUG Cyclophosphamide
- DRUG Doxorubicin Hydrochloride
- DRUG Etoposide
- DRUG Ifosfamide
- DRUG Dexrazoxane
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 642 participants |
| Start Date | 2010-11-24 |
| Est. Completion | 2025-12-31 |
| Phase | Phase 3 |
What the finished NCT01231906 record still lists
NCT01231906 is an interventional study that assigns participants to a tested intervention. The registered 642 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 (17% lower).
The record links to 0 conditions, and to 5 interventions - of which Cyclophosphamide is the first listed.
NCT01231906 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01231906 about?
NCT01231906 is a clinical study titled "Combination Chemotherapy in Treating Patients With Non-Metastatic Extracranial Ewing Sarcoma". This trial examined the outcome benefit to patients of adding a new chemotherapy drug combination to the established treatment approach for patients with extracranial Ewing sarcoma, that had not spread from the primary site to other places in the body. The trial randomly assigned patients at the tim...
What is the current status of trial NCT01231906?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 642 participants. The study started on 2010-11-24. Estimated completion is 2025-12-31.
What interventions are being tested in trial NCT01231906?
The interventions under investigation include: Cyclophosphamide (DRUG), Doxorubicin Hydrochloride (DRUG), Etoposide (DRUG), Ifosfamide (DRUG), Dexrazoxane (DRUG).
Who is sponsoring clinical trial NCT01231906?
This trial is sponsored by Children's Oncology Group, which has 342 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01231906's enrollment target sits among peer trials
642 574th of 2000 higher than 1,426 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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