Trial · NCT00104676

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

NCT00104676, Phase 3, Completed, UNICANCER; results first posted 2021-06-07

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Combination Chemotherapy in Treating Patients With Stage II or Stage III Germ Cell Tumors. Trials, record NCT00104676. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00104676

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Combination Chemotherapy in Treating Patients With Stage II or Stage III Germ Cell Tumors
NCT number: NCT00104676
Status: Completed
Phases: Phase 3
Enrollment: 263 participants, actual
Lead sponsor: UNICANCER
Conditions: Extragonadal Germ Cell Tumor, Teratoma, Testicular Germ Cell Tumor
Interventions: bleomycin sulfate, cisplatin, etoposide, ifosfamide, oxaliplatin, paclitaxel
First posted: 2005-03-04
Last updated: 2025-02-06
Other registries' IDs: eudract:2005-001072-13
Results first posted: 2021-06-07

Source ClinicalTrials.gov

Registered outcomes2

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Progression-free Survival Rate After 1 Course of Treatment	3 years from randomization	Primary objective is to compare the progression-free survival of participants after 1 cycle of treatment, treated randomly by 3 additional cycles of BEP (Arm I) or by T-BEP-Oxaliplatin/cisplatin-ifosfamide-Bleomycin (Arm II). The median progression-free survival rate was defined as the median percentage of participants alive without disease progression after 1 course of treatment.
Secondary	Overall Survival	3 years from randomization	To evaluated the overall survival in both groups in participants presenting fast and slow decrease in serum levels of tumor markers. The median overall survival was defined as the median percentage of participants alive after 1 course of treatment.

Source ClinicalTrials.gov

Outcomes2

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Progression-free Survival Rate After 1 Course of Treatment	3 years from randomization	The primary endpoint for the study was the comparison of the PFS rates in the population of participants with a poor prognostic non-seminomatous germ cell tumors and with an unfavorable decrease in tumor biomarkers, randomized to either Unfav-BEP Control Arm (Arm I) or Unfav-Dose-Dense Arm (Arm II).	percentage of participants	NUMBER
SECONDARY	Overall Survival	3 years from randomization		percentage of participants	NUMBER

Source ClinicalTrials.gov

Results by group4

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Progression-free Survival Rate After 1 Course of Treatment	Arm I	48	95% Confidence Interval 38 to 59	percentage of participants
Progression-free Survival Rate After 1 Course of Treatment	Arm II	59	95% Confidence Interval 49 to 68	percentage of participants
Overall Survival	Arm I	65	95% Confidence Interval 55 to 75	percentage of participants
Overall Survival	Arm II	73	95% Confidence Interval 64 to 81	percentage of participants

Source ClinicalTrials.gov

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Arm I	98
Overall Study	STARTED	Arm II	105
Overall Study	COMPLETED	Arm I	91
Overall Study	COMPLETED	Arm II	91
Overall Study	NOT COMPLETED	Arm I	7
Overall Study	NOT COMPLETED	Arm II	14

Source ClinicalTrials.gov

Adverse events184

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Rash	Skin and subcutaneous tissue disorders	Arm I	18	98
other	Rash	Skin and subcutaneous tissue disorders	Arm II	27	105
other	Nausea	Gastrointestinal disorders	Arm I	72	98
other	Nausea	Gastrointestinal disorders	Arm II	91	105
other	Diarrhea	Gastrointestinal disorders	Arm I	20	98
other	Diarrhea	Gastrointestinal disorders	Arm II	52	105
other	Mucositis	Gastrointestinal disorders	Arm I	18	98
other	Mucositis	Gastrointestinal disorders	Arm II	45	105
other	Liver function test increased	Hepatobiliary disorders	Arm I	43	98
other	Liver function test increased	Hepatobiliary disorders	Arm II	36	105

1 to 10 of 184Source ClinicalTrials.gov

See all 184 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Arm I	61	98
Total, all-cause mortality	Arm II	66	105
Total, other adverse events	Arm I	98	98
Total, other adverse events	Arm II	105	105
Total, serious adverse events	Arm I	37	98
Total, serious adverse events	Arm II	58	105

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
25456363	DERIVED	PubMed
39167741	DERIVED	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Arm I vs Arm II: deaths from any cause	Trial comparisons
Arm I vs Arm II: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00104676

GET https://conductscience.org/api/trials/v1/NCT00104676/events?page=2

API reference For AI assistants