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NCT00104676 · REGISTRY CONDITION SEARCH

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

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
PHASE3
Status at capture
COMPLETED
Registry last update
2025-02-06

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Progression-free Survival Rate After 1 Course of Treatment

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outcome · POSTED

Overall Survival

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
eligibility Criteria
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
healthy Volunteers
false
maximum Age
120 Years
minimum Age
16 Years
sex
ALL
std Ages
  1. CHILD
  2. ADULT
  3. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Patients receive 4 courses of bleomycin, etoposide, and cisplatin (BEP).
    intervention Names
    1. Biological: bleomycin sulfate
    2. Drug: cisplatin
    3. Drug: etoposide
    label
    Arm I
    type
    ACTIVE_COMPARATOR
  2. 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.
    intervention Names
    1. Biological: bleomycin sulfate
    2. Drug: cisplatin
    3. Drug: etoposide
    4. Drug: ifosfamide
    5. Drug: oxaliplatin
    6. Drug: paclitaxel
    label
    Arm II
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Arm I
    2. Arm II
    description
    At least one course administered
    name
    bleomycin sulfate
    type
    BIOLOGICAL
  2. arm Group Labels
    1. Arm I
    2. Arm II
    description
    At least one course administered
    name
    cisplatin
    type
    DRUG
  3. arm Group Labels
    1. Arm I
    2. Arm II
    description
    At least one course administered
    name
    etoposide
    type
    DRUG
  4. arm Group Labels
    1. Arm II
    description
    Given in a dose-dense sequential fashion
    name
    ifosfamide
    type
    DRUG
  5. arm Group Labels
    1. Arm II
    description
    Given in a dose-dense sequential fashion
    name
    oxaliplatin
    type
    DRUG
  6. arm Group Labels
    1. Arm II
    description
    Given in a dose-dense sequential fashion
    name
    paclitaxel
    type
    DRUG
Study design
allocation
RANDOMIZED
intervention Model
PARALLEL
intervention Model Description
Phase 3 trial with direct individual benefit, randomized, open-label, multicenter, parallel groups
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
263
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    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.
    measure
    Progression-free Survival Rate After 1 Course of Treatment
    time Frame
    3 years from randomization
secondary Outcomes
  1. description
    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.
    measure
    Overall Survival
    time Frame
    3 years from randomization
Full study description
brief 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.
detailed Description
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.
Source references
references
  1. citation
    Fizazi 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
    type
    DERIVED
  2. citation
    Fizazi 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
    type
    DERIVED
Source notices and limitations
    Discovery and provenance
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    Preserved source evidence · Not medical advice