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NCT00653068 · ClinicalTrials.gov registry record · Phase 3
Combination Chemotherapy, Radiation Therapy, and an Autologous Peripheral Blood Stem Cell Transplant in Treating Young Patients With Atypical Teratoid/Rhabdoid Tumor of the Central Nervous System
A Phase 3 study, sponsored by Children's Oncology Group.
- Completed
- Registry status
- Phase 3
- Development phase
- 70
- Enrollment target
NCT00653068: Completed Phase 3 study, sponsored by Children's Oncology Group.
NCT00653068 is a Phase 3 study that has completed, run by Children's Oncology Group. The registered enrollment target is 70 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (91% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00653068, a Phase 3 study, has completed, sponsored by Children's Oncology Group.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 70 participants
- Enrollment target
Study Summary
This phase III trial studies the side effects of combination chemotherapy, 3-dimensional conformal radiation therapy, and an autologous peripheral blood stem cell transplant, and to see how well they work in treating young patients with atypical teratoid/rhabdoid tumor of the central nervous system. Giving high-dose chemotherapy before an autologous peripheral blood stem cell transplant stops the growth of cancer cells by stopping them from dividing or killing them. Giving colony-stimulating factors, such as G-CSF, helps stem cells move from the bone marrow to the blood so they can be collected and stored. Chemotherapy or radiation therapy is then given to prepare the bone marrow for the stem cell transplant. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy or radiation therapy.
Primary Outcome
Estimated 4-year EFS where EFS is calculated as the time from study enrollment to disease progression, disease relapse, occurrence of a second malignant neoplasm, death from any cause or last follow-up whichever occurs first. Kaplan-Meier method is used for estimation. Patients without an event are censored at last contact.
Interventions
- DRUG Cyclophosphamide
- DRUG Carboplatin
- DRUG Cisplatin
- PROCEDURE Autologous Hematopoietic Stem Cell Transplantation
- RADIATION 3-Dimensional Conformal Radiation Therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 70 participants |
| Start Date | 2009-02-10 |
| Est. Completion | 2024-03-31 |
| Phase | Phase 3 |
What the finished NCT00653068 record still lists
NCT00653068 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 70 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (91% lower).
The record links to 0 conditions, and to 5 interventions - of which Cyclophosphamide is the first listed.
NCT00653068 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00653068 about?
NCT00653068 is a clinical study titled "Combination Chemotherapy, Radiation Therapy, and an Autologous Peripheral Blood Stem Cell Transplant in Treating Young Patients With Atypical Teratoid/Rhabdoid Tumor of the Central Nervous System". This phase III trial studies the side effects of combination chemotherapy, 3-dimensional conformal radiation therapy, and an autologous peripheral blood stem cell transplant, and to see how well they work in treating young patients with atypical teratoid/rhabdoid tumor of the central nervous system....
What is the current status of trial NCT00653068?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 70 participants. The study started on 2009-02-10. Estimated completion is 2024-03-31.
What interventions are being tested in trial NCT00653068?
The interventions under investigation include: Cyclophosphamide (DRUG), Carboplatin (DRUG), Cisplatin (DRUG), Autologous Hematopoietic Stem Cell Transplantation (PROCEDURE), 3-Dimensional Conformal Radiation Therapy (RADIATION).
Who is sponsoring clinical trial NCT00653068?
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 NCT00653068's enrollment target sits among peer trials
70 1785th of 2000 higher than 208 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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