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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00002596
Registration number
NCT00002596
Ethics application status
Date submitted
1/11/1999
Date registered
27/01/2003
Date last updated
26/06/2013
Titles & IDs
Public title
Combination Chemotherapy With or Without Bone Marrow or Stem Cell Transplantation in Treating Men With Untreated Germ Cell Tumors
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Scientific title
RANDOMIZED MULTIINSTITUTIONAL PHASE III TRIAL OF BEP AND HIGH DOSE CHEMOTHERAPY VERSUS BEP ALONE IN PREVIOUSLY UNTREATED PATIENTS WITH POOR RISK GERM CELL TUMORS
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Secondary ID [1]
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MSKCC-94076
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Secondary ID [2]
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SWOG-9442
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Childhood Germ Cell Tumor
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Extragonadal Germ Cell Tumor
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Testicular Germ Cell Tumor
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Condition category
Condition code
Cancer
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Ovarian and primary peritoneal
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Cancer
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Testicular
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Cancer
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Other cancer types
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - bleomycin sulfate
Other interventions - filgrastim
Treatment: Drugs - carboplatin
Treatment: Drugs - cisplatin
Treatment: Drugs - cyclophosphamide
Treatment: Drugs - etoposide
Treatment: Surgery - autologous bone marrow transplantation
Treatment: Surgery - bone marrow ablation with stem cell support
Treatment: Surgery - conventional surgery
Treatment: Surgery - peripheral blood stem cell transplantation
Treatment: Other - radiation therapy
Other interventions: bleomycin sulfate
Other interventions: filgrastim
Treatment: Drugs: carboplatin
Treatment: Drugs: cisplatin
Treatment: Drugs: cyclophosphamide
Treatment: Drugs: etoposide
Treatment: Surgery: autologous bone marrow transplantation
Treatment: Surgery: bone marrow ablation with stem cell support
Treatment: Surgery: conventional surgery
Treatment: Surgery: peripheral blood stem cell transplantation
Treatment: Other: radiation therapy
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Intervention code [1]
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Other interventions
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Intervention code [2]
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Treatment: Drugs
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Treatment: Surgery
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Treatment: Other
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Control group
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Outcomes
Eligibility
Key inclusion criteria
DISEASE CHARACTERISTICS:
- Histologically proven poor-risk, nonseminoma germ cell tumor
- Must meet 1 of the following 3 conditions:
- Testis or retroperitoneal primary site without visceral metastasis but with
any of the following tumor marker values:
- Lactic dehydrogenase (LDH) greater than 10 times upper limit of normal
(ULN)
- Human chorionic gonadotropin (hCG) greater than 50,000 IU/L
- Alpha-fetoprotein (AFP) greater than 10,000 ng/mL
- Testis or retroperitoneal primary site with 1 or more nonpulmonary visceral
metastases (regardless of tumor marker values), including the following:
- Bone
- Brain
- Liver
- Other nonpulmonary viscera (e.g., skin, spleen)
- Mediastinal primary site, regardless of presence/absence of visceral
metastasis or tumor marker values OR
- Histologically proven intermediate-risk, nonseminoma germ cell tumor
- Testis or retroperitoneal primary site with no visceral metastasis (except lung),
and with any of the following tumor marker values:
- LDH 3-10 times ULN
- hCG 5,000-50,000 IU/L
- AFP 1,000-10,000 ng/mL OR
- Histologically proven intermediate-risk, seminoma germ cell tumor with 1 or more
nonpulmonary visceral metastases (regardless of tumor marker values or primary site),
including the following:
- Bone
- Brain
- Liver
- Other nonpulmonary visceral metastasis (e.g., skin, spleen)
- Histologic confirmation may be delayed, at the discretion of the protocol chairman,
until after initiation of study therapy for patients with a testicular mass and
elevated AFP or hCG if medical circumstances warrant immediate treatment
- Measurable or evaluable disease
- Concurrent registration on protocol MSKCC-89076 (SWOG-9345) for tumor biology studies
required
PATIENT CHARACTERISTICS:
Age:
- 12 and over
Sex:
- Male
Performance status:
- Not specified
Life expectancy:
- Not specified
Hematopoietic:
- WBC at least 3,000/mm^3
- Platelet count at least 100,000/mm^3
Hepatic:
- See Disease Characteristics
Renal:
- Creatinine no greater than ULN* OR
- Creatinine clearance greater than 50 mL/min* NOTE: * Abnormal levels due to ureteral
obstruction by tumor allowed at the discretion of the protocol chairman
Other:
- HIV negative
- No other concurrent malignancy except nonmelanomatous skin cancer
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- No prior chemotherapy
- No other concurrent chemotherapy
Endocrine therapy:
- Not specified
Radiotherapy:
- At least 30 days since prior radiotherapy except for brain metastases or documented
disease progression
- Recovered from the toxic effects of any prior radiotherapy
Surgery:
- Recovered from the effects of any recent surgery
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Minimum age
12
Years
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Maximum age
No limit
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Sex
Males
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Can healthy volunteers participate?
No
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Key exclusion criteria
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
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Intervention assignment
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/09/1994
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/07/2006
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Sample size
Target
270
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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Westmead Hospital - Westmead
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Recruitment postcode(s) [1]
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2145 - Westmead
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Recruitment outside Australia
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Alabama
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Colorado
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Lima
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San Juan
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Funding & Sponsors
Primary sponsor type
Other
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Name
Memorial Sloan Kettering Cancer Center
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Address
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Name [1]
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National Cancer Institute (NCI)
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Other
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Eastern Cooperative Oncology Group
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Other
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SWOG Cancer Research Network
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Other
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Cancer and Leukemia Group B
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Ethics approval
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Summary
Brief summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
they stop growing or die. It is not known whether combining chemotherapy with bone marrow or
peripheral stem cell transplantation is more effective than combination chemotherapy alone in
treating men with germ cell tumors.
PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy
with or without bone marrow or peripheral stem cell transplantation in treating men with
previously untreated germ cell tumors.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00002596
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Robert J. Motzer, MD
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Address
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Memorial Sloan Kettering Cancer Center
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00002596
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