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NCT00085098 · ClinicalTrials.gov registry record · Phase 3
Radiation Therapy Compared With Chemotherapy and Radiation Therapy in Treating Patients With Newly Diagnosed Primary Central Nervous System (CNS) Germ Cell Tumor
A Phase 3 study, sponsored by Children's Oncology Group.
- Completed
- Registry status
- Phase 3
- Development phase
- 24
- Enrollment target
NCT00085098: Completed Phase 3 study, sponsored by Children's Oncology Group.
NCT00085098 is a Phase 3 study that has completed, run by Children's Oncology Group. The registered enrollment target is 24 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00085098, a Phase 3 study, has completed, sponsored by Children's Oncology Group.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 24 participants
- Enrollment target
Study Summary
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether radiation therapy alone is as effective as chemotherapy plus radiation therapy in treating germ cell tumor. PURPOSE: This randomized phase III trial is studying radiation therapy alone to see how well it works compared to chemotherapy and radiation therapy in treating patients with newly diagnosed primary CNS germ cell tumor.
Primary Outcome
Data will be summarized as number of patients in the following categories at the time of data cutoff for analyses of 3-year EFS: 1)Experienced a qualifying event (QE) (see below);2)Event-free through 3 years of follow-up;3)Event-free until data cutoff (if less than 3 years of follow-up);4)Withdrew from study;5)Lost to follow-up. QEs: 1)disease progression, defined as increase \>= 40% in tumor volume or \>= 25% in tumor area of target lesions;2)development of new lesions;3)occurrence of a second
Interventions
- DRUG cisplatin
- DRUG carboplatin
- DRUG cyclophosphamide
- DRUG etoposide
- BIOLOGICAL filgrastim
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2007-01 |
| Est. Completion | 2009-05 |
| Phase | Phase 3 |
What the finished NCT00085098 record still lists
NCT00085098 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 5 interventions - of which cisplatin is the first listed.
NCT00085098 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00085098 about?
NCT00085098 is a clinical study titled "Radiation Therapy Compared With Chemotherapy and Radiation Therapy in Treating Patients With Newly Diagnosed Primary Central Nervous System (CNS) Germ Cell Tumor". RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether radiation therapy alone is as effective as chemotherapy plus radiation therapy in t...
What is the current status of trial NCT00085098?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 24 participants. The study started on 2007-01. Estimated completion is 2009-05.
What interventions are being tested in trial NCT00085098?
The interventions under investigation include: cisplatin (DRUG), carboplatin (DRUG), cyclophosphamide (DRUG), etoposide (DRUG), filgrastim (BIOLOGICAL).
Who is sponsoring clinical trial NCT00085098?
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 NCT00085098's enrollment target sits among peer trials
24 1943rd of 2000 higher than 49 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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