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Paclitaxel, Ifosfamide and Cisplatin (TIP) Versus Bleomycin, Etoposide and Cisplatin (BEP) for Patients With Previously Untreated Intermediate- and Poor-risk Germ Cell Tumors

NCT01873326 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 92

Last updated 2025-07-03

No results posted yet for this 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.

Conditions

  • Germ Cell Tumors

Interventions

DRUG

Paclitaxel

DRUG

Ifosfamide

DRUG

Cisplatin

DRUG

Mesna

DRUG

Bleomycin

DRUG

Etoposide

Sponsors & Collaborators

  • University of Southern California

    collaborator OTHER

  • Mayo Clinic

    collaborator OTHER

  • University of Pittsburgh

    collaborator OTHER

  • University of North Carolina

    collaborator OTHER

  • University of Chicago

    collaborator OTHER

  • Stanford University

    collaborator OTHER

  • University of Texas Southwestern Medical Center

    collaborator OTHER

  • Memorial Sloan Kettering Cancer Center

    lead OTHER

Principal Investigators

  • Darren Feldman, MD · Memorial Sloan Kettering Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-06-30
Primary Completion
2026-06-30
Completion
2026-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01873326 on ClinicalTrials.gov