Clinical trial · Interventional

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

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

NCT00104676CI-TRIAL-00085582completedPhase 3Results postedClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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

Conditions (3)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Extragonadal Germ Cell Tumor	Extragonadal Germ Cell Tumor	ONTOLOGY_EXACT	0.98
Teratoma	Teratoma	ONTOLOGY_EXACT	0.90
Testicular Germ Cell Tumor	Testicular Germ Cell Tumor	ONTOLOGY_EXACT	0.90

Interventions

Interventions (6)

Intervention	Type	Mapped drug	Match
bleomycin sulfate	Biological	Bleomycin	ALIAS
cisplatin	Drug	Cisplatin	ALIAS
etoposide	Drug	Etoposide	ALIAS
ifosfamide	Drug	Ifosfamide	ALIAS
oxaliplatin	Drug	Oxaliplatin	ALIAS
paclitaxel	Drug	Paclitaxel	ALIAS

Design

Arms and outcomes

Arms (2)

type
ACTIVE_COMPARATOR
label
Arm I
description
Patients receive 4 courses of bleomycin, etoposide, and cisplatin (BEP).
interventionNames
1. Biological: bleomycin sulfate
2. Drug: cisplatin
3. Drug: etoposide
type
EXPERIMENTAL
label
Arm II
description
Patients receive 1 course of bleomycin, etoposide, and cisplatin (BEP). Patients then receive dose-dense sequential combination chemotherapy comprising cisplatin, etoposide, bleomycin, paclitaxel, oxaliplatin, and ifosfamide.
interventionNames
1. Biological: bleomycin sulfate
2. Drug: cisplatin
3. Drug: etoposide
4. Drug: ifosfamide
5. Drug: oxaliplatin
6. Drug: paclitaxel

Primary outcomes (1)

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 16 Years
Maximum age: 120 Years

Show eligibility criteria text

DISEASE CHARACTERISTICS:

* Diagnosis of non-seminomatous germ cell tumors (NSGCT) as evidenced by 1 of the following criteria:

  * Histologically confirmed NSGCT
  * Clinical evidence of disease AND high serum human chorionic gonadotropin (HCG) or alpha-fetoprotein (AFP) levels
* Clinical stage II-III disease (disseminated disease)
* Testicular, retroperitoneal, or mediastinal primary site
* Poor prognosis disease, meeting 1 of the following criteria:

  * Mediastinal primary site
  * Non-pulmonary visceral metastases
  * One of the following lab values:

    * HCG \> 50,000 UI/L
    * AFP \> 10,000 ng/mL
    * Lactate dehydrogenase \> 10 times upper limit of normal (ULN)

PATIENT CHARACTERISTICS:

Age

* Over 16

Performance status

* Not specified

Life expectancy

* Not specified

Hematopoietic

* Absolute granulocyte count ≥ 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3

Hepatic

* Bilirubin ≤ 1.5 times ULN

Renal

* Creatinine clearance \> 60 mL/min

Other

* No other prior malignancy except basal cell skin cancer
* No HIV positivity

PRIOR CONCURRENT THERAPY:

Biologic therapy

* Not specified

Chemotherapy

* No prior chemotherapy

Endocrine therapy

* Not specified

Radiotherapy

* Not specified

Surgery

* Not specified

References

Publications (2)

DERIVEDFizazi K, Le Teuff G, Flechon A, Pagliaro L, Mardiak J, Geoffrois L, Laguerre B, Chevreau C, Delva R, Rolland F, Theodore C, Roubaud G, Gravis G, Eymard JC, Cancel M, Juzyna B, Reckova M, Naoun N, Logothetis C, Culine S. Personalized Chemotherapy on the Basis of Tumor Marker Decline in Poor-Prognosis Germ-Cell Tumors: Updated Analysis of the GETUG-13 Phase III Trial. J Clin Oncol. 2024 Oct;42(28):3270-3276. doi: 10.1200/JCO.23.01960. Epub 2024 Aug 21. PMID 39167741
DERIVEDFizazi K, Pagliaro L, Laplanche A, Flechon A, Mardiak J, Geoffrois L, Kerbrat P, Chevreau C, Delva R, Rolland F, Theodore C, Roubaud G, Gravis G, Eymard JC, Malhaire JP, Linassier C, Habibian M, Martin AL, Journeau F, Reckova M, Logothetis C, Culine S. Personalised chemotherapy based on tumour marker decline in poor prognosis germ-cell tumours (GETUG 13): a phase 3, multicentre, randomised trial. Lancet Oncol. 2014 Dec;15(13):1442-1450. doi: 10.1016/S1470-2045(14)70490-5. Epub 2014 Nov 13. PMID 25456363

Registry

Dates and enrollment

Start: Nov 26, 2003
Primary completion: Mar 29, 2012
Completion: Feb 8, 2023
First posted: Mar 4, 2005
Last update posted: Feb 6, 2025
Results first posted: Jun 7, 2021
Enrollment: 263 (actual)
Lead sponsor: UNICANCER OTHER
Keywords: stage II malignant testicular germ cell tumor, stage III malignant testicular germ cell tumor, testicular choriocarcinoma and embryonal carcinoma, testicular choriocarcinoma and teratoma, testicular choriocarcinoma and yolk sac tumor, testicular choriocarcinoma, testicular embryonal carcinoma and teratoma, testicular embryonal carcinoma and yolk sac tumor, testicular embryonal carcinoma, testicular yolk sac tumor and teratoma, testicular yolk sac tumor, stage II extragonadal non-seminomatous germ cell tumor, stage III extragonadal non-seminomatous germ cell tumor, testicular immature teratoma, testicular mature teratoma, adult teratoma

Data updated 22 days agoSource updated Feb 6, 2025source: clinicaltrials

Locations

Locations by country (24)

Country	Sites

France	22	0
Slovakia	1	0
United States	1	0