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Combination Chemotherapy in Treating Patients With Stage II or Stage III Germ Cell Tumors

NCT00104676 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 263

Last updated 2025-02-06

Study results available
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Summary

RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.

PURPOSE: This randomized phase III trial is comparing two different combination chemotherapy regimens to see how well they work in treating patients with stage II or stage III non-seminomatous germ cell tumors.

Conditions

  • Extragonadal Germ Cell Tumor
  • Teratoma
  • Testicular Germ Cell Tumor

Interventions

BIOLOGICAL

bleomycin sulfate

At least one course administered

DRUG

cisplatin

At least one course administered

DRUG

etoposide

At least one course administered

DRUG

ifosfamide

Given in a dose-dense sequential fashion

DRUG

oxaliplatin

Given in a dose-dense sequential fashion

DRUG

paclitaxel

Given in a dose-dense sequential fashion

Sponsors & Collaborators

  • UNICANCER

    lead OTHER

Principal Investigators

  • Karim Fizazi, MD, PhD · Gustave Roussy, Cancer Campus, Grand Paris

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
120 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-11-26
Primary Completion
2012-03-29
Completion
2023-02-08
FDA Drug
Yes

Countries

  • United States
  • France
  • Slovakia

Study Locations

More Related Trials

Entities

Drugs

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 NCT00104676 on ClinicalTrials.gov