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NCT Number: NCT00104676

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

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.

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Key information

Conditions

Extragonadal Germ Cell Tumor Carcinoma, Embryonal Endocrine Gland Neoplasms Endocrine System Diseases Endodermal Sinus Tumor Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Gonadal Disorders Male Urogenital Diseases Mesonephroma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Teratoma Testicular Diseases Testicular Germ Cell Tumor Testicular Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

16 year–120 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Centre Paul Papin, Angers, France

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About this study

OBJECTIVES:

  • Compare progression-free survival rates of patients with poor prognosis stage II or III non-seminomatous germ cell tumors with an unfavorable decrease of tumor markers after treatment with 1 course of bleomycin, etoposide, and cisplatin followed by subsequent treatment with 3 additional courses of bleomycin, etoposide, and cisplatin OR dose-dense sequential combination chemotherapy.
  • Compare overall survival of patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study.

Patients receive 1 course of bleomycin, etoposide, and cisplatin (BEP). Patients with a favorable decrease of tumor markers after 1 course of BEP receive 3 additional courses of BEP. Patients with an unfavorable decrease of tumor markers after 1 course of BEP are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive 3 additional courses of BEP.
  • Arm II: Patients receive dose-dense sequential combination chemotherapy comprising cisplatin, etoposide, bleomycin, paclitaxel, oxaliplatin, and ifosfamide.

PROJECTED ACCRUAL: A total of 260 patients will be accrued for this study.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

bleomycin sulfate

Biological

At least one course administered

Cisplatin

Drug

At least one course administered

etoposide

Drug

At least one course administered

ifosfamide

Drug

Given in a dose-dense sequential fashion

Oxaliplatin

Drug

Given in a dose-dense sequential fashion

paclitaxel

Drug

Given in a dose-dense sequential fashion

Primary outcomes

  1. Progression-free Survival Rate After 1 Course of Treatment

    Time frame: 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 outcomes

  1. Overall Survival

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

UNICANCER

Other

Registry information

Official study title

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

Important dates

Study start
2003
Primary completion
2012
Study completion
2023
First posted
Mar 4, 2005
Registry last updated
Feb 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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