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NCT00003811 · ClinicalTrials.gov registry record · Phase 2
Combination Chemotherapy Plus Amifostine in Treating Children With Malignant Germ Cell Tumors
A Phase 2 study, sponsored by Children's Oncology Group.
- Completed
- Registry status
- Phase 2
- Development phase
- 27
- Enrollment target
NCT00003811: Completed Phase 2 study, sponsored by Children's Oncology Group.
NCT00003811 is a Phase 2 study that has completed, run by Children's Oncology Group. The registered enrollment target is 27 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00003811, a Phase 2 study, has completed, sponsored by Children's Oncology Group.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 27 participants
- Enrollment target
Study Summary
RATIONALE: Chemotherapy drugs use different ways to stop tumor cells from dividing so they stop growing or die. Chemoprotective drugs such as amifostine may protect normal cells from the side effects of chemotherapy. PURPOSE: Phase I trial to study the effectiveness of high-dose cisplatin, etoposide, and bleomycin plus amifostine in treating children who have malignant germ cell tumors.
Primary Outcome
The hazard rate is constant over 1.39 years, then the probability of the occurrence of a failure within this time interval follows a Poisson distribution. The table below shows the trial feasibility probabilities associated with those failure rates. We define the probability of feasibility as the probability of observing a total of at most less than three failures in 25 patient years of follow-up.
Interventions
- DRUG cisplatin
- DRUG etoposide
- PROCEDURE conventional surgery
- DRUG amifostine trihydrate
- BIOLOGICAL bleomycin sulfate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 27 participants |
| Start Date | 2000-04 |
| Est. Completion | 2007-09 |
| Phase | Phase 2 |
What the finished NCT00003811 record still lists
NCT00003811 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 27 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (80% lower).
The record links to 0 conditions, and to 5 interventions - of which cisplatin is the first listed.
NCT00003811 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00003811 about?
NCT00003811 is a clinical study titled "Combination Chemotherapy Plus Amifostine in Treating Children With Malignant Germ Cell Tumors". RATIONALE: Chemotherapy drugs use different ways to stop tumor cells from dividing so they stop growing or die. Chemoprotective drugs such as amifostine may protect normal cells from the side effects of chemotherapy. PURPOSE: Phase I trial to study the effectiveness of high-dose cisplatin, etoposid...
What is the current status of trial NCT00003811?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 27 participants. The study started on 2000-04. Estimated completion is 2007-09.
What interventions are being tested in trial NCT00003811?
The interventions under investigation include: cisplatin (DRUG), etoposide (DRUG), conventional surgery (PROCEDURE), amifostine trihydrate (DRUG), bleomycin sulfate (BIOLOGICAL).
Who is sponsoring clinical trial NCT00003811?
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 NCT00003811's enrollment target sits among peer trials
27 1697th of 2000 higher than 293 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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