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NCT01873326 · ClinicalTrials.gov registry record · Phase 2
Paclitaxel, Ifosfamide and Cisplatin (TIP) Versus Bleomycin, Etoposide and Cisplatin (BEP) for Patients With Previously Untreated Intermediate- and Poor-risk Germ Cell Tumors
A Phase 2 study of Germ Cell Tumors, sponsored by Memorial Sloan Kettering Cancer Center.
- Active
- Registry status
- Phase 2
- Development phase
- 92
- Enrollment target
- 13
- Study locations
NCT01873326: Active Phase 2 study of Germ Cell Tumors, sponsored by Memorial Sloan Kettering Cancer Center.
NCT01873326 is a Phase 2 study of Germ Cell Tumors that is active but no longer recruiting, run by Memorial Sloan Kettering Cancer Center. The registered enrollment target is 92 participants, above the 63-participant average among 3 other Germ Cell Tumors trials with a reported enrollment target (46% higher). The trial reports 13 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01873326, a Phase 2 study of Germ Cell Tumors, is active but no longer recruiting, sponsored by Memorial Sloan Kettering Cancer Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 92 participants
- Enrollment target
- 13
- Study locations
Study Summary
The purpose of this study is to learn about the safety and effectiveness of two different drug combinations in patients who have intermediate- and poor-risk germ cell tumors (GCT). One combination of drugs, paclitaxel, ifosfamide and cisplatin (TIP), is experimental. The other combination of drugs, bleomycin, etoposide and cisplatin (BEP), is the standard of care treatment for intermediate- and poor-risk germ cell tumors. However, BEP does not cure every patient and therefore newer treatments are needed.
Primary Outcome
Favorable best response is defined as complete response or partial response with negative tumor markers. Patients will be considered evaluable for the primary endpoint of favorable response within the first 6 months if they complete at least 3 cycles of study treatment (without switch to an alternative chemotherapy regimen) and achieve a confirmed partial response with negative markers or confirmed complete response (considered as favorable responses). Patients will also be considered evaluable
Conditions Studied
Interventions
- DRUG Cisplatin
- DRUG Mesna
- DRUG Paclitaxel
- DRUG Ifosfamide
- DRUG Bleomycin
Study Locations (13)
New York
- Memorial Sloan Kettering Cancer Center @ Suffolk - Commack
- Memorial Sloan Kettering Westchester - Harrison
- Memorial Sloan Kettering Cancer Center - New York
- Memorial Sloan Kettering Nassau - Uniondale
New Jersey
- Memorial Sloan Kettering Cancer Center - Basking Ridge
- Memorial Sloan Kettering Monmouth - Middletown
- Memorial Sloan Kettering Bergen (Follow-up Only) - Montvale
California
- University of Southern California - Los Angeles
- Stanford University Medical Center - Stanford
Illinois
- University of Chicago - Chicago
Minnesota
- Mayo Clinic - Rochester
North Carolina
- University of North Carolina - Chapel Hill
Pennsylvania
- University of Pittsburgh Medical Center - Pittsburgh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 92 participants |
| Start Date | 2013-06 |
| Est. Completion | 2026-06 |
| Phase | Phase 2 |
What the registry record for NCT01873326 still lists
NCT01873326 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 92 participants, a relatively small participant target, above the 63-participant average among 3 other Germ Cell Tumors trials with a reported enrollment target (46% higher).
The record links to 1 condition, with Germ Cell Tumors appearing as the primary indexed condition, and to 5 interventions - of which Cisplatin is the first listed.
NCT01873326 lists 13 locations in 7 states (New York, New Jersey, California).
Frequently Asked Questions
What is clinical trial NCT01873326 about?
NCT01873326 is a clinical study titled "Paclitaxel, Ifosfamide and Cisplatin (TIP) Versus Bleomycin, Etoposide and Cisplatin (BEP) for Patients With Previously Untreated Intermediate- and Poor-risk Germ Cell Tumors". The purpose of this study is to learn about the safety and effectiveness of two different drug combinations in patients who have intermediate- and poor-risk germ cell tumors (GCT). One combination of drugs, paclitaxel, ifosfamide and cisplatin (TIP), is experimental. The other combination of drugs, ...
What is the current status of trial NCT01873326?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 92 participants. The study started on 2013-06. Estimated completion is 2026-06.
What conditions does trial NCT01873326 study?
This clinical trial studies the following conditions: Germ Cell Tumors.
What interventions are being tested in trial NCT01873326?
The interventions under investigation include: Cisplatin (DRUG), Mesna (DRUG), Paclitaxel (DRUG), Ifosfamide (DRUG), Bleomycin (DRUG).
Who is sponsoring clinical trial NCT01873326?
This trial is sponsored by Memorial Sloan Kettering Cancer Center, which has 1,884 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01873326 being conducted?
This trial has 13 study locations across California, Illinois, Minnesota, New Jersey, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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