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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 is a Phase 2 study that has completed, run by Children's Oncology Group. The registered enrollment target is 104 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00047320
The ClinicalTrials.gov registry entry for NCT00047320 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 104 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Children's Oncology Group, which has 342 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which carboplatin is the first listed.
NCT00047320 reports 0 study locations.
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.
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