Status:
UNKNOWN
Observation and/or Combination Chemotherapy After Surgery or Biopsy in Treating Young Patients With Extracranial Germ Cell Tumors
Lead Sponsor:
Children's Cancer and Leukaemia Group
Conditions:
Childhood Germ Cell Tumor
Extragonadal Germ Cell Tumor
Eligibility:
All Genders
Up to 17 years
Phase:
PHASE3
Brief Summary
RATIONALE: Sometimes, after surgery, the tumor may not need additional treatment until it progresses. In this case, observation may be sufficient. Drugs used in chemotherapy work in different ways to ...
Detailed Description
OBJECTIVES: * Stratify and reduce treatment for pediatric patients with extracranial germ cell tumors while maintaining event-free survival. * Treat newly diagnosed patients with extracranial germ ce...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically\* proven extracranial malignant germ cell tumor (GCT), including mature/immature teratoma, with or without elevated alpha-fetoprotein (AFP) or human chorionic gonadotropin (HCG) levels
- Newly diagnosed disease
- Patients with relapsed or progressive extracranial malignant GCT allowed if previously treated with carboplatin, etoposide, and bleomycin (JEB) chemotherapy
- Patients relapsing following JEB are eligible for the study relapse strategy NOTE: \*Patients with unequivocally raised AFP/HCG whose risk of biopsy is felt to be high can be diagnosed by clinical grounds, imaging, and markers
- No intracranial GCTs
- PATIENT CHARACTERISTICS:
- Neutrophil count ≥ 1,000/mm\^3
- Platelet count ≥ 100,000/mm\^3
- Bilirubin ≤ 2 times upper limit of normal (ULN)
- ALT ≤ 3 times ULN
- Not pregnant or nursing
- PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior chemotherapy other than JEB
Exclusion
Key Trial Info
Start Date :
May 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
105 Patients enrolled
Trial Details
Trial ID
NCT00274950
Start Date
May 1 2005
Last Update
September 17 2013
Active Locations (20)
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1
Our Lady's Hospital for Sick Children Crumlin
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
Addenbrooke's Hospital
Cambridge, England, United Kingdom, CB2 2QQ