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NCT00003994 · ClinicalTrials.gov registry record · Phase 3
Combination Chemotherapy With or Without Amifostine in Treating Young Patients With Liver Cancer
A Phase 3 study, sponsored by Children's Oncology Group.
- Completed
- Registry status
- Phase 3
- Development phase
- 277
- Enrollment target
NCT00003994: Completed Phase 3 study, sponsored by Children's Oncology Group.
NCT00003994 is a Phase 3 study that has completed, run by Children's Oncology Group. The registered enrollment target is 277 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (64% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00003994, a Phase 3 study, has completed, sponsored by Children's Oncology Group.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 277 participants
- Enrollment target
Study Summary
Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. Chemoprotective drugs such as amifostine may protect normal cells from the side effects of chemotherapy. It is not yet known which chemotherapy regimen is most effective for children and young adults with liver cancer. This randomized phase III trial is studying giving combination chemotherapy together with amifostine to see how well it works compared to combination chemotherapy alone in treating patients with liver cancer.
Primary Outcome
EFS rates will be estimated using the method of Kaplan and Meier. Survival curves will be compared using stratified logrank tests.
Interventions
- DRUG cisplatin
- PROCEDURE therapeutic conventional surgery
- DRUG fluorouracil
- DRUG amifostine trihydrate
- DRUG vincristine sulfate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 277 participants |
| Start Date | 1999-03 |
| Phase | Phase 3 |
What the finished NCT00003994 record still lists
NCT00003994 is an interventional study that assigns participants to a tested intervention. The registered 277 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 (64% lower).
The record links to 0 conditions, and to 5 interventions - of which cisplatin is the first listed.
NCT00003994 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00003994 about?
NCT00003994 is a clinical study titled "Combination Chemotherapy With or Without Amifostine in Treating Young Patients With Liver Cancer". Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. Chemoprotective drugs such as amifostine may protect normal cells from the side effects of chemotherapy. It is not yet known which ...
What is the current status of trial NCT00003994?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 277 participants. The study started on 1999-03.
What interventions are being tested in trial NCT00003994?
The interventions under investigation include: cisplatin (DRUG), therapeutic conventional surgery (PROCEDURE), fluorouracil (DRUG), amifostine trihydrate (DRUG), vincristine sulfate (DRUG).
Who is sponsoring clinical trial NCT00003994?
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 NCT00003994's enrollment target sits among peer trials
277 1202nd of 2000 higher than 799 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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