CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 263 enrolled
Drug / intervention
bleomycin sulfate +5 morebiological
Likely dose
Dose-dense sequential regimen: cisplatin, etoposide, bleomycin, followed by ifosfamide, oxaliplatin, and paclitaxelAI-extracted
Key inclusion· 6
  • ✓Histologically confirmed non-seminomatous germ cell tumor (NSGCT)
  • ✓Clinical evidence of NSGCT with high serum HCG or AFP levels
  • ✓Clinical stage II-III disseminated disease
  • ✓Primary tumor site: testicular, retroperitoneal, or mediastinal
Key exclusion· 3
  • ✕Prior chemotherapy
  • ✕HIV positivity
  • ✕Other prior malignancy except basal cell skin cancer

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00104676
NCT00104676Phase 3Completed
CompareCT.gov

A Risk-Adapted Strategy of the Use of Dose-Dense Chemotherapy in Patients With Poor-Prognosis Disseminated Non-Seminomatous Germ Cell Tumors

UNICANCER·interventional·Posted Mar 4, 2005·Updated Feb 6, 2025

In Brief

A Phase 3 clinical trial evaluating bleomycin sulfate, cisplatin, and 4 other interventions for Extragonadal Germ Cell Tumor and 2 related conditions. Completed, enrolled 263 participants across 24 sites in 3 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsExtragonadal Germ Cell Tumor, Teratoma, Testicular Germ Cell Tumor
CountriesFrance, Slovakia, United States
Collaborators--

Timeline

Phase 3CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 4, 2005
Enrollment StartNov 26, 2003
Primary CompletionMar 29, 2012
Study CompletionFeb 8, 2023
TodayJul 2, 2026
Enrollment to primary: 8.3 yearsPosted 21.3 years ago

Interventions

bleomycin sulfatebiological

At least one course administered

cisplatindrug

At least one course administered

etoposidedrug

At least one course administered

ifosfamidedrug

Given in a dose-dense sequential fashion

oxaliplatindrug

Given in a dose-dense sequential fashion

paclitaxeldrug

Given in a dose-dense sequential fashion