Germ Cell Tumour Study II
N/A
15 Years
Both
Brain and Central Nervous System Tumors, Childhood Germ Cell Tumor, Extragonadal Germ Cell Tumor, Ovarian Cancer
Trial Information
Germ Cell Tumour Study II
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 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.
Inclusion Criteria
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
Type of Study:
Interventional
Study Design:
Masking: Open Label, Primary Purpose: Treatment
Principal Investigator
A. Oakhill, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Bristol Royal Hospital for Children
Authority:
United States: Federal Government
Study ID:
CDR0000454749
NCT ID:
NCT00276718
Start Date:
April 1989
Completion Date:
Related Keywords:
- Brain and Central Nervous System Tumors
- Childhood Germ Cell Tumor
- Extragonadal Germ Cell Tumor
- Ovarian Cancer
- childhood malignant ovarian germ cell tumor
- childhood malignant testicular germ cell tumor
- childhood central nervous system germ cell tumor
- childhood extragonadal germ cell tumor
- childhood teratoma
- Nervous System Neoplasms
- Ovarian Neoplasms
- Central Nervous System Neoplasms
- Neoplasms, Germ Cell and Embryonal
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