Status:
UNKNOWN
Etoposide, Carboplatin, and Bleomycin in Treating Young Patients Undergoing Surgery For Malignant Germ Cell Tumors
Lead Sponsor:
Children's Cancer and Leukaemia Group
Conditions:
Brain and Central Nervous System Tumors
Childhood Germ Cell Tumor
Eligibility:
All Genders
Up to 15 years
Phase:
NA
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as etoposide, carboplatin, and bleomycin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from div...
Detailed Description
OBJECTIVES: * 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 base...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- 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
Exclusion
Key Trial Info
Start Date :
April 1 1989
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00276718
Start Date
April 1 1989
Last Update
September 17 2013
Active Locations (22)
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1
Our Lady's Hospital for Sick Children
Dublin, Ireland, 12
2
Birmingham Children's Hospital
Birmingham, England, United Kingdom, B4 6NH
3
Institute of Child Health at University of Bristol
Bristol, England, United Kingdom, BS2 8AE
4
Bristol Royal Hospital for Children
Bristol, England, United Kingdom, BS2 8BJ