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NCT00084838 · ClinicalTrials.gov registry record · Phase 2
Chemotherapy Combined With Radiation Therapy for Newly Diagnosed CNS AT/RT
A Phase 2 study, sponsored by Dana-Farber Cancer Institute.
- Completed
- Registry status
- Phase 2
- Development phase
- 25
- Enrollment target
NCT00084838: Completed Phase 2 study, sponsored by Dana-Farber Cancer Institute.
NCT00084838 is a Phase 2 study that has completed, run by Dana-Farber Cancer Institute. The registered enrollment target is 25 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (81% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00084838, a Phase 2 study, has completed, sponsored by Dana-Farber Cancer Institute.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 25 participants
- Enrollment target
Study Summary
RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Giving more than one chemotherapy drug with radiation therapy may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving intrathecal and systemic combination chemotherapy together with radiation therapy works in treating young patients with newly diagnosed central nervous system (CNS) atypical teratoid/rhabdoid tumors.
Primary Outcome
Overall survival is defined as the time from date of diagnosis to death or date of last follow-up. 2-year overall survival is the probability of patients remaining alive at 2-years from study entry estimated using Kaplan-Meier (KM) methods which censors patients at date of last follow-up. Precision of this conditional probability estimate was measured in terms of standard error. Median OS, the original primary endpoint, was not estimable based on the Kaplan-Meier method because of insufficient f
Interventions
- DRUG cisplatin
- DRUG cyclophosphamide
- BIOLOGICAL filgrastim
- DRUG dexrazoxane hydrochloride
- DRUG cytarabine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2003-02 |
| Est. Completion | 2013-03 |
| Phase | Phase 2 |
What the finished NCT00084838 record still lists
NCT00084838 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (81% lower).
The record links to 0 conditions, and to 5 interventions - of which cisplatin is the first listed.
NCT00084838 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00084838 about?
NCT00084838 is a clinical study titled "Chemotherapy Combined With Radiation Therapy for Newly Diagnosed CNS AT/RT". RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Giving more than one chemotherapy drug with radiation therapy may kill more tumor cells. PURPOSE: This phase I...
What is the current status of trial NCT00084838?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 25 participants. The study started on 2003-02. Estimated completion is 2013-03.
What interventions are being tested in trial NCT00084838?
The interventions under investigation include: cisplatin (DRUG), cyclophosphamide (DRUG), filgrastim (BIOLOGICAL), dexrazoxane hydrochloride (DRUG), cytarabine (DRUG).
Who is sponsoring clinical trial NCT00084838?
This trial is sponsored by Dana-Farber Cancer Institute, which has 781 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00084838's enrollment target sits among peer trials
25 1719th of 2000 higher than 245 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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