Standard-Dose Combination Chemotherapy or High-Dose Combination Chemotherapy and Stem Cell Transplant in Treating Patients With Relapsed or Refractory Germ Cell Tumors
Public ClinicalTrials.gov record NCT02375204. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Randomized Phase III Trial Comparing Conventional-Dose Chemotherapy Using Paclitaxel, Ifosfamide, and Cisplatin (TIP) With High-Dose Chemotherapy Using Mobilizing Paclitaxel Plus Ifosfamide Followed by High-Dose Carboplatin and Etoposide (TI-CE) as First Salvage Treatment in Relapsed or Refractory Germ Cell Tumors
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT02375204
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 420 participants
Conditions and interventions
Conditions
Interventions
- paclitaxel Drug
- ifosfamide Drug
- cisplatin Drug
- pegylated G-CSF Drug
- G-CSF Drug
- carboplatin Drug
- etoposide phosphate Drug
- stem cell reinfusion Procedure
Drug · Procedure
Eligibility (public fields only)
- Age range
- 14 Years and older
- Sex
- Male
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 6, 2015 (Actual)
- Primary completion
- Jun 1, 2031 (Estimated)
- Completion
- Jun 1, 2031 (Estimated)
- Last update posted
- Jun 16, 2026
2015 – 2031
United States locations
- U.S. sites
- 77
- U.S. states
- 27
- U.S. cities
- 64
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Children's Hospital of Alabama | Birmingham | Alabama | 35233 | — |
| UC San Diego Moores Cancer Center | La Jolla | California | 92093 | — |
| Loma Linda University Medical Center | Loma Linda | California | 92354 | — |
| USC / Norris Comprehensive Cancer Center | Los Angeles | California | 90033 | — |
| Kaiser Permanente-Oakland | Oakland | California | 94611 | — |
| Stanford Cancer Institute Palo Alto | Palo Alto | California | 94304 | — |
| UCSF Medical Center-Mission Bay | San Francisco | California | 94158 | — |
| Alfred I duPont Hospital for Children | Wilmington | Delaware | 19803 | — |
| MedStar Georgetown University Hospital | Washington D.C. | District of Columbia | 20007 | — |
| University of Florida Health Science Center - Gainesville | Gainesville | Florida | 32610 | — |
| Nemours Children's Clinic-Jacksonville | Jacksonville | Florida | 32207 | — |
| Nicklaus Children's Hospital | Miami | Florida | 33155 | — |
| Miami Cancer Institute | Miami | Florida | 33176 | — |
| Arnold Palmer Hospital for Children | Orlando | Florida | 32806 | — |
| Johns Hopkins All Children's Hospital | St. Petersburg | Florida | 33701 | — |
| Saint Joseph's Hospital/Children's Hospital-Tampa | Tampa | Florida | 33607 | — |
| Emory University Hospital/Winship Cancer Institute | Atlanta | Georgia | 30322 | — |
| Northwestern University | Chicago | Illinois | 60611 | — |
| Rush University Medical Center | Chicago | Illinois | 60612 | — |
| University of Illinois | Chicago | Illinois | 60612 | — |
| University of Chicago Comprehensive Cancer Center | Chicago | Illinois | 60637 | — |
| Ascension Via Christi Hospitals Wichita | Wichita | Kansas | 67214 | — |
| Cancer Center of Kansas - Wichita | Wichita | Kansas | 67214 | — |
| Ochsner Medical Center Jefferson | New Orleans | Louisiana | 70121 | — |
| Dana-Farber Cancer Institute | Boston | Massachusetts | 02215 | — |
| University of Michigan Comprehensive Cancer Center | Ann Arbor | Michigan | 48109 | — |
| Spectrum Health at Butterworth Campus | Grand Rapids | Michigan | 49503 | — |
| University of Michigan Health - West | Wyoming | Michigan | 49519 | — |
| Children's Hospitals and Clinics of Minnesota - Minneapolis | Minneapolis | Minnesota | 55404 | — |
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | — |
| Washington University School of Medicine | St Louis | Missouri | 63110 | — |
| Nebraska Methodist Hospital | Omaha | Nebraska | 68114 | — |
| Summerlin Hospital Medical Center | Las Vegas | Nevada | 89144 | — |
| Memorial Sloan Kettering Basking Ridge | Basking Ridge | New Jersey | 07920 | — |
| Hackensack University Medical Center | Hackensack | New Jersey | 07601 | — |
| Memorial Sloan Kettering Monmouth | Middletown | New Jersey | 07748 | — |
| Saint Joseph's Regional Medical Center | Paterson | New Jersey | 07503 | — |
| Roswell Park Cancer Institute | Buffalo | New York | 14263 | — |
| Memorial Sloan Kettering Commack | Commack | New York | 11725 | — |
| Memorial Sloan Kettering Westchester | Harrison | New York | 10604 | — |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | — |
| Memorial Sloan Kettering Nassau | Uniondale | New York | 11553 | — |
| UNC Lineberger Comprehensive Cancer Center | Chapel Hill | North Carolina | 27599 | — |
| Carolinas Medical Center/Levine Cancer Institute | Charlotte | North Carolina | 28203 | — |
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229 | — |
| Ohio State University Comprehensive Cancer Center | Columbus | Ohio | 43210 | — |
| University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma | 73104 | — |
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | — |
| University of Pennsylvania/Abramson Cancer Center | Philadelphia | Pennsylvania | 19104 | — |
| University of Pittsburgh Cancer Institute (UPCI) | Pittsburgh | Pennsylvania | 15232 | — |
| Rhode Island Hospital | Providence | Rhode Island | 02903 | — |
| Prisma Health Cancer Institute - Spartanburg | Boiling Springs | South Carolina | 29316 | — |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | — |
| Prisma Health Cancer Institute - Easley | Easley | South Carolina | 29640 | — |
| Saint Francis Hospital | Greenville | South Carolina | 29601 | — |
| BI-LO Charities Children's Cancer Center | Greenville | South Carolina | 29605 | — |
| Prisma Health Cancer Institute - Butternut | Greenville | South Carolina | 29605 | — |
| Prisma Health Cancer Institute - Faris | Greenville | South Carolina | 29605 | — |
| Prisma Health Greenville Memorial Hospital | Greenville | South Carolina | 29605 | — |
| Saint Francis Cancer Center | Greenville | South Carolina | 29607 | — |
| Prisma Health Cancer Institute - Eastside | Greenville | South Carolina | 29615 | — |
| Prisma Health Cancer Institute - Greer | Greer | South Carolina | 29650 | — |
| Prisma Health Cancer Institute - Seneca | Seneca | South Carolina | 29672 | — |
| Spartanburg Medical Center | Spartanburg | South Carolina | 29303 | — |
| Saint Jude Children's Research Hospital | Memphis | Tennessee | 38105 | — |
| The Children's Hospital at TriStar Centennial | Nashville | Tennessee | 37203 | — |
| Vanderbilt University/Ingram Cancer Center | Nashville | Tennessee | 37232 | — |
| El Paso Children's Hospital | El Paso | Texas | 79905 | — |
| M D Anderson Cancer Center | Houston | Texas | 77030 | — |
| Seattle Children's Hospital | Seattle | Washington | 98105 | — |
| Marshfield Medical Center-EC Cancer Center | Eau Claire | Wisconsin | 54701 | — |
| Marshfield Medical Center-Marshfield | Marshfield | Wisconsin | 54449 | — |
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | — |
| Marshfield Clinic-Minocqua Center | Minocqua | Wisconsin | 54548 | — |
| Marshfield Medical Center-Rice Lake | Rice Lake | Wisconsin | 54868 | — |
| Marshfield Medical Center-River Region at Stevens Point | Stevens Point | Wisconsin | 54482 | — |
| Marshfield Medical Center - Weston | Weston | Wisconsin | 54476 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 48 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02375204, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 16, 2026 · Synced Oct 17, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02375204 live on ClinicalTrials.gov.