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NCT00304070 · ClinicalTrials.gov registry record · Phase 3
Cisplatin-Based Chemotherapy and/or Surgery in Treating Young Patients With Adrenocortical Tumor
A Phase 3 study, sponsored by Children's Oncology Group.
- Completed
- Registry status
- Phase 3
- Development phase
- 78
- Enrollment target
NCT00304070: Completed Phase 3 study, sponsored by Children's Oncology Group.
NCT00304070 is a Phase 3 study that has completed, run by Children's Oncology Group. The registered enrollment target is 78 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00304070, a Phase 3 study, has completed, sponsored by Children's Oncology Group.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 78 participants
- Enrollment target
Study Summary
This phase III clinical trial is studying how well cisplatin-based chemotherapy and/or surgery works in treating young patients with stage I, stage II, stage III or stage IV adrenocortical cancer. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Giving chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving it after surgery may kill any tumor cells that remain after surgery.
Primary Outcome
The model used for comparison will be an exponential model with a constant failure rate of 0.053 (stratum I), 0.347 (stratum II), 0.602 (stratum III and IV) per year for the first two years and 0 after that. The one-sample one-sided log-rank test comparing the observed data with the hypothesized model (Woolson, 1981) of size 0.05 will be used to assess whether the data are consistent with the target models. Since this test has independent increments, the method of Lan and DeMets will be used to
Interventions
- DRUG Cisplatin
- DRUG Doxorubicin Hydrochloride
- DRUG Etoposide
- BIOLOGICAL Filgrastim
- PROCEDURE Conventional Surgery
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 78 participants |
| Start Date | 2007-05-03 |
| Est. Completion | 2023-06-30 |
| Phase | Phase 3 |
What the finished NCT00304070 record still lists
NCT00304070 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 78 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (90% lower).
The record links to 0 conditions, and to 5 interventions - of which Cisplatin is the first listed.
NCT00304070 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00304070 about?
NCT00304070 is a clinical study titled "Cisplatin-Based Chemotherapy and/or Surgery in Treating Young Patients With Adrenocortical Tumor". This phase III clinical trial is studying how well cisplatin-based chemotherapy and/or surgery works in treating young patients with stage I, stage II, stage III or stage IV adrenocortical cancer. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells...
What is the current status of trial NCT00304070?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 78 participants. The study started on 2007-05-03. Estimated completion is 2023-06-30.
What interventions are being tested in trial NCT00304070?
The interventions under investigation include: Cisplatin (DRUG), Doxorubicin Hydrochloride (DRUG), Etoposide (DRUG), Filgrastim (BIOLOGICAL), Conventional Surgery (PROCEDURE).
Who is sponsoring clinical trial NCT00304070?
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 NCT00304070's enrollment target sits among peer trials
78 1769th of 2000 higher than 230 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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