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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
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
Secondary ID [1] 0 0
MSKCC-94076
Secondary ID [2] 0 0
SWOG-9442
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Childhood Germ Cell Tumor 0 0
Extragonadal Germ Cell Tumor 0 0
Testicular Germ Cell Tumor 0 0
Condition category
Condition code
Cancer 0 0 0 0
Ovarian and primary peritoneal
Cancer 0 0 0 0
Testicular
Cancer 0 0 0 0
Other cancer types

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Comparator / control treatment
Control group

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
Minimum age
12 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/09/1994
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/07/2006
Sample size
Target
270
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Westmead Hospital - Westmead
Recruitment postcode(s) [1] 0 0
2145 - Westmead
Recruitment outside Australia
Country [1] 0 0
United States of America
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Alabama
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Arizona
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Arkansas
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California
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Colorado
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Delaware
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District of Columbia
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United States of America
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Florida
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Hawaii
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Idaho
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Illinois
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Indiana
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Iowa
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Kansas
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Kentucky
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Louisiana
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Maryland
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Massachusetts
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Michigan
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Minnesota
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Mississippi
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Missouri
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Nebraska
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Nevada
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New Hampshire
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New Jersey
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New Mexico
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New York
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North Carolina
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United States of America
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North Dakota
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Ohio
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United States of America
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Oklahoma
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United States of America
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Oregon
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United States of America
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Pennsylvania
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United States of America
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Rhode Island
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United States of America
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South Dakota
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United States of America
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Tennessee
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United States of America
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Texas
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United States of America
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Utah
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United States of America
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Vermont
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Virginia
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Washington
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West Virginia
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United States of America
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Wisconsin
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Peru
State/province [45] 0 0
Lima
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Puerto Rico
State/province [46] 0 0
San Juan

Funding & Sponsors
Primary sponsor type
Other
Name
Memorial Sloan Kettering Cancer Center
Address
Country
Other collaborator category [1] 0 0
Government body
Name [1] 0 0
National Cancer Institute (NCI)
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Eastern Cooperative Oncology Group
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
SWOG Cancer Research Network
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
Cancer and Leukemia Group B
Address [4] 0 0
Country [4] 0 0

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT00002596
Trial related presentations / publications
Motzer RJ, Nichols CJ, Margolin KA, Bacik J, Richardson PG, Vogelzang NJ, Bajorin DF, Lara PN Jr, Einhorn L, Mazumdar M, Bosl GJ. Phase III randomized trial of conventional-dose chemotherapy with or without high-dose chemotherapy and autologous hematopoietic stem-cell rescue as first-line treatment for patients with poor-prognosis metastatic germ cell tumors. J Clin Oncol. 2007 Jan 20;25(3):247-56. doi: 10.1200/JCO.2005.05.4528.
Bajorin DF, Nichols CR, Margolin KA, et al.: Phase III trial of conventional-dose chemotherapy alone or with high-dose chemotherapy for metastatic germ cell tumors (GCT) patients (PTS): a cooperative group trial by Memorial Sloan-Kettering Cancer Center, ECOG, SWOG, and CALGB. [Abstract] J Clin Oncol 24 (Suppl 18): A-4510, 2006.
Public notes

Contacts
Principal investigator
Name 0 0
Robert J. Motzer, MD
Address 0 0
Memorial Sloan Kettering Cancer Center
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00002596