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NCT00047320 · ClinicalTrials.gov registry record · Phase 2
Neoadjuvant Chemotherapy With or Without Second-Look Surgery Followed by Radiation Therapy With or Without Peripheral Stem Cell Transplantation in Treating Patients With Intracranial Germ Cell Tumors
A Phase 2 study, sponsored by Children's Oncology Group.
- Completed
- Registry status
- Phase 2
- Development phase
- 104
- Enrollment target
NCT00047320: Completed Phase 2 study, sponsored by Children's Oncology Group.
NCT00047320 is a Phase 2 study that has completed, run by Children's Oncology Group. The registered enrollment target is 104 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (22% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00047320, a Phase 2 study, has completed, sponsored by Children's Oncology Group.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 104 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. Giving a chemotherapy drug before surgery may shrink the tumor so that it is no longer present by conventional imaging and tumor markers from serum and cerebrospinal fluid. Radiation therapy uses high-energy x-rays to damage tumor cells. Peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. Combining different types of therapy may kill more tumor cells. PURPOSE: This Phase II trial is studying how well neoadjuvant chemotherapy with or without surgery and with or without high dose chemotherapy and peripheral stem cell transplantation, can increase response rates prior to radiation therapy and increase progression free and overall surviving patients with newly diagnosed intracranial germ cell tumors.
Primary Outcome
A patient who achieves a complete or partial response, defined a reduction of at least 65% in tumor size after induction chemotherapy will be considered to have experienced response.
Interventions
- DRUG carboplatin
- DRUG etoposide
- DRUG ifosfamide
- PROCEDURE adjuvant therapy
- DRUG thiotepa
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 104 participants |
| Start Date | 2004-01 |
| Est. Completion | 2009-02 |
| Phase | Phase 2 |
What the finished NCT00047320 record still lists
NCT00047320 is an interventional study that assigns participants to a tested intervention. The registered 104 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (22% lower).
The record links to 0 conditions, and to 5 interventions - of which carboplatin is the first listed.
NCT00047320 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00047320 about?
NCT00047320 is a clinical study titled "Neoadjuvant Chemotherapy With or Without Second-Look Surgery Followed by Radiation Therapy With or Without Peripheral Stem Cell Transplantation in Treating Patients With Intracranial Germ Cell Tumors". RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Giving a chemotherapy drug before surgery may shrink the tumor so that it is no longer present by conventional imaging and tumor markers from serum and cerebrospinal fluid. Rad...
What is the current status of trial NCT00047320?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 104 participants. The study started on 2004-01. Estimated completion is 2009-02.
What interventions are being tested in trial NCT00047320?
The interventions under investigation include: carboplatin (DRUG), etoposide (DRUG), ifosfamide (DRUG), adjuvant therapy (PROCEDURE), thiotepa (DRUG).
Who is sponsoring clinical trial NCT00047320?
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 NCT00047320's enrollment target sits among peer trials
104 660th of 2000 higher than 1,337 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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