Etoposide, Carboplatin, and Bleomycin in Treating Young Patients Undergoing Surgery For Malignant Germ Cell Tumors
NCT ID: NCT00276718
Last Updated: 2013-09-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
100 participants
INTERVENTIONAL
1989-04-30
Brief Summary
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PURPOSE: This clinical trial is studying how well giving etoposide, carboplatin, and bleomycin works in treating young patients undergoing surgery for malignant germ cell tumors.
Detailed Description
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* Determine the toxic effects of etoposide, carboplatin, and bleomycin in young patients with malignant germ cell tumors.
OUTLINE: Patients are assigned to one of two treatment arms based on their tumor type (testicular vs ovarian, uterine, vaginal, sacrococcygeal, retroperitoneal, or thoracic).
* Group 1 (testicular tumors): Patients undergo radical orchiectomy. Patients with stage I tumors and alpha-fetoprotein (AFP) decreasing at the expected rate receive no further treatment unless there is a subsequent rise in the AFP or a clinical recurrence. Patients with stage II-IV tumors receive etoposide IV over 1 hour on days 1-3, carboplatin IV over 1 hour on day 2, and bleomycin IV over 15 minutes on day 3. Treatment repeats every 21- 28 days for at least 4 courses in the absence of disease progression or unacceptable toxicity. Residual teratoma may be removed, if indicated, after completion of chemotherapy.
* Group 2 (ovarian, uterine, vaginal, sacrococcygeal, retroperitoneal, or thoracic germ cell tumors): Patients undergo surgical removal or biopsy of the tumor. Patients then receive etoposide, carboplatin, and bleomycin as above. Patients may then undergo further surgery at the discretion of the principal investigator.
After completion of study treatment, patients are followed periodically.
PROJECTED ACCRUAL: A total of 100 patients will be accrued for this study.
Conditions
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Keywords
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Study Design
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TREATMENT
NONE
Interventions
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bleomycin sulfate
carboplatin
etoposide
conventional surgery
Eligibility Criteria
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Inclusion Criteria
* Histologically proven malignant germ cell tumors at all stages
* Testicular tumors
* Stage I - Confined to testes
* Stage II - Confined to testes and retroperitoneal/abdominal lymph nodes
* Stage III - Supradiaphragmatic nodal disease (mediastinal and/or supraclavicular)
* Stage IV - Extralymphatic spread (liver, lung, bone, brain, skin, etc.)
* Ovarian, uterine, vaginal, and sacrococcygeal tumors
* Stage I - Confined to ovary/uterus/vagina/pre- and postsacral area
* Stage II - Spread limited to the pelvis
* Stage III - Spread limited to the abdomen (excluding liver)
* Stage IV - Spread to liver or beyond the abdominal cavity
* Abdominal, retroperitoneal, and thoracic primary tumors
* Stage I - Confined to site of origin and resectable
* Stage II - Local spread
* Stage III - Extensive spread confined to one side of the diaphragm (excluding the liver)
* Stage IV - Tumor spread to the liver, to both sides of the diaphragm, and/or to bones, bone marrow, brain, etc.
* Intracranial germ cell tumor cases allowed even if an alternative protocol is being followed
PATIENT CHARACTERISTICS:
* Not specified
PRIOR CONCURRENT THERAPY:
* No prior chemotherapy
15 Years
ALL
No
Sponsors
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Children's Cancer and Leukaemia Group
OTHER
Principal Investigators
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A. Oakhill, MD
Role: STUDY_CHAIR
Bristol Royal Hospital for Children
Michael Sokal
Role:
Nottingham City Hospital
P. Gornall, MD
Role:
Birmingham Children's Hospital
Locations
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Our Lady's Hospital for Sick Children
Dublin, , Ireland
Birmingham Children's Hospital
Birmingham, England, United Kingdom
Institute of Child Health at University of Bristol
Bristol, England, United Kingdom
Bristol Royal Hospital for Children
Bristol, England, United Kingdom
Addenbrooke's Hospital at Cambridge University Hospitals NHS Foundation Trust
Cambridge, England, United Kingdom
Leeds Cancer Centre at St. James's University Hospital
Leeds, England, United Kingdom
Leicester Royal Infirmary
Leicester, England, United Kingdom
Royal Liverpool Children's Hospital, Alder Hey
Liverpool, England, United Kingdom
Royal London Hospital
London, England, United Kingdom
Great Ormond Street Hospital for Children NHS Trust
London, England, United Kingdom
Central Manchester and Manchester Children's University Hospitals NHS Trust
Manchester, England, United Kingdom
Sir James Spence Institute of Child Health
Newcastle upon Tyne, England, United Kingdom
Queen's Medical Centre
Nottingham, England, United Kingdom
Oxford Radcliffe Hospital
Oxford, England, United Kingdom
Children's Hospital - Sheffield
Sheffield, England, United Kingdom
Southampton General Hospital
Southampton, England, United Kingdom
Royal Marsden NHS Foundation Trust - Surrey
Sutton, England, United Kingdom
Royal Belfast Hospital for Sick Children
Belfast, Northern Ireland, United Kingdom
Royal Aberdeen Children's Hospital
Aberdeen, Scotland, United Kingdom
Royal Hospital for Sick Children
Edinburgh, Scotland, United Kingdom
Royal Hospital for Sick Children
Glasgow, Scotland, United Kingdom
Childrens Hospital for Wales
Cardiff, Wales, United Kingdom
Countries
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Other Identifiers
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CCLG-GC-1989-01
Identifier Type: -
Identifier Source: secondary_id
EU-20583
Identifier Type: -
Identifier Source: secondary_id
CDR0000454749
Identifier Type: -
Identifier Source: org_study_id