Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Active Phase 3 study of Germ Cell Tumor and Yolk Sac Tumor, sponsored by Alliance for Clinical Trials in Oncology.
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. According to ClinicalTrials.gov, the official US trial registry.
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 |
What the registry record for NCT02375204 still lists
NCT02375204 is an interventional study that assigns participants to a tested intervention. The registered 420 participants enrollment target is mid-sized for trials with a published cap, above the 326-participant average among 19 other Germ Cell Tumor trials with a reported enrollment target (29% higher).
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 names 20 study sites across 7 states, led by 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, Non-seminomatous Germ Cell Tumor, Mixed 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.
Learn More About Clinical Trials
Similar trials for Germ Cell Tumor
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02375204's enrollment target sits among peer trials
420 6th of 19 higher than 14 of 19 other Germ Cell Tumor trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Germ Cell Tumor 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
-
Active Surveillance, Bleomycin, Etoposide, Carboplatin or Cisplatin in Treating Pediatric and Adult Patients With Germ Cell Tumors
RECRUITING · Phase 3
-
Accelerated v's Standard BEP Chemotherapy for Patients With Intermediate and Poor-risk Metastatic Germ Cell Tumours
RECRUITING · Phase 3
-
Phase 1, Safety and Tolerability Study of XmAb541 in Advanced Solid Tumors
RECRUITING · Phase 1
-
Study of B7-H3-Specific CAR T Cell Locoregional Immunotherapy for Diffuse Intrinsic Pontine Glioma/Diffuse Midline Glioma and Recurrent or Refractory Pediatric Central Nervous System Tumors
RECRUITING · Phase 1
-
Maintenance Oral Etoposide or Observation Following High-dose Chemo for GCT
RECRUITING · Phase 2
-
Germ Cell Tumor and Testicular Tumor DNA Registry
RECRUITING
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT01790152 · 420 participants
Effects of Dexrazoxane Hydrochloride on Biomarkers Associated With Cardiomyopathy and Heart Failure After Cancer Treatment
- NCT02701244 · 420 participants
A Registry Study of Breast Microseed Treatment
- NCT02966665 · 420 participants · Phase 1
: Vascular Function in Health and Disease
- NCT04149743 · 420 participants · NA
HEMOTAG® Assessment for Short-term Outcomes of Heart Failure
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI