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NCT02375204 · ClinicalTrials.gov registry record · Phase 3
Standard-Dose Combination Chemotherapy or High-Dose Combination Chemotherapy and Stem Cell Transplant in Treating Patients with Relapsed or Refractory Germ Cell Tumors
A Phase 3 study of Germ Cell Tumor and Yolk Sac Tumor, sponsored by Alliance for Clinical Trials in Oncology.
- Active
- Registry status
- Phase 3
- Development phase
- 420
- Enrollment target
- 20
- Study locations
NCT02375204 is a Phase 3 study of Germ Cell Tumor and Yolk Sac Tumor that is active but no longer recruiting, run by Alliance for Clinical Trials in Oncology. The registered enrollment target is 420 participants, above the 326-participant average among 19 other Germ Cell Tumor trials with a reported enrollment target (29% higher). The trial reports 20 study locations across 7 states.
The verdict
NCT02375204, a Phase 3 study of Germ Cell Tumor and Yolk Sac Tumor, is active but no longer recruiting, sponsored by Alliance for Clinical Trials in Oncology.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 420 participants
- Enrollment target
- 20
- Study locations
Study Summary
This randomized phase III trial studies how well standard-dose combination chemotherapy works compared to high-dose combination chemotherapy and stem cell transplant in treating patients with germ cell tumors that have returned after a period of improvement or did not respond to treatment. Drugs used in chemotherapy, such as paclitaxel, ifosfamide, cisplatin, carboplatin, and etoposide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving chemotherapy before a stem cell transplant stops the growth of cancer cells by stopping them from dividing or killing them. Giving colony-stimulating factors, such as filgrastim or pegfilgrastim, and certain chemotherapy drugs, helps stem cells move from the bone marrow to the blood so they can be collected and stored. Chemotherapy 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. It is not yet known whether high-dose combination chemotherapy and stem cell transplant are more effective than standard-dose combination chemotherapy in treating patients with refractory or relapsed germ cell tumors.
Conditions Studied
Interventions
- DRUG G-CSF
- DRUG cisplatin
- DRUG paclitaxel
- DRUG ifosfamide
- DRUG pegylated G-CSF
Study Locations (20)
Florida
- University of Florida Health Science Center - Gainesville - Gainesville
- Nemours Children's Clinic-Jacksonville - Jacksonville
- Nicklaus Children's Hospital - Miami
- Miami Cancer Institute - Miami
- Arnold Palmer Hospital for Children - Orlando
- Johns Hopkins All Children's Hospital - St. Petersburg
- Saint Joseph's Hospital/Children's Hospital-Tampa - Tampa
California
- UC San Diego Moores Cancer Center - La Jolla
- Loma Linda University Medical Center - Loma Linda
- USC / Norris Comprehensive Cancer Center - Los Angeles
- Kaiser Permanente-Oakland - Oakland
- Stanford Cancer Institute Palo Alto - Palo Alto
- UCSF Medical Center-Mission Bay - San Francisco
Illinois
- Northwestern University - Chicago
- Rush University Medical Center - Chicago
- University of Illinois - Chicago
Alabama
- Children's Hospital of Alabama - Birmingham
Delaware
- Alfred I duPont Hospital for Children - Wilmington
District of Columbia
- MedStar Georgetown University Hospital - Washington D.C.
Georgia
- Emory University Hospital/Winship Cancer Institute - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 420 participants |
| Start Date | 2015-08-06 |
| Est. Completion | 2031-06-01 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02375204
The ClinicalTrials.gov registry entry for NCT02375204 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 420 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 326-participant average among 19 other Germ Cell Tumor trials with a reported enrollment target (29% higher). The listed sponsor is Alliance for Clinical Trials in Oncology, which has 446 total studies on file at ClinicalTrials.gov.
The record links to 10 conditions, with Germ Cell Tumor appearing as the primary indexed condition, and to 5 interventions - of which G-CSF is the first listed.
NCT02375204 reports 20 study locations spanning 7 distinct geographic areas - top geographies include Florida, California, Illinois.
Frequently Asked Questions
What is clinical trial NCT02375204 about?
NCT02375204 is a clinical study titled "Standard-Dose Combination Chemotherapy or High-Dose Combination Chemotherapy and Stem Cell Transplant in Treating Patients with Relapsed or Refractory Germ Cell Tumors". This randomized phase III trial studies how well standard-dose combination chemotherapy works compared to high-dose combination chemotherapy and stem cell transplant in treating patients with germ cell tumors that have returned after a period of improvement or did not respond to treatment. Drugs use...
What is the current status of trial NCT02375204?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 420 participants. The study started on 2015-08-06. Estimated completion is 2031-06-01.
What conditions does trial NCT02375204 study?
This clinical trial studies the following conditions: Germ Cell Tumor, Yolk Sac Tumor, Choriocarcinoma, Mixed Germ Cell Tumor, Non-seminomatous Germ Cell Tumor.
What interventions are being tested in trial NCT02375204?
The interventions under investigation include: G-CSF (DRUG), cisplatin (DRUG), paclitaxel (DRUG), ifosfamide (DRUG), pegylated G-CSF (DRUG).
Who is sponsoring clinical trial NCT02375204?
This trial is sponsored by Alliance for Clinical Trials in Oncology, which has 446 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02375204 being conducted?
This trial has 20 study locations across Alabama, California, Delaware, District of Columbia, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.