Cross-Sectional Evaluation of Outcome Following Extra-Cranial Germ Cell Tumors Treated According to UKCCSG GC 7901 (GC I) and GC 8901 (GC II) Protocols
- Determine the late effects of treatment and the quality-of-life of patients with germ
cell tumors (GCT) previously treated on clinical trial CCLG-GC-1979-01 or
- Evaluate the late effects of carboplatin, etoposide, and bleomycin in patients treated
on clinical trial CCLG-GC-1989-01.
- Determine the toxicity of bleomycin and a combination of either cisplatin and
vinblastine, etoposide and cisplatin, or carboplatin and etoposide in patients treated
on clinical trial CCLG-GC-1979-01.
- Evaluate tumor-associated/surgical morbidity (bladder, bowel, and lower limb function)
in patients with malignant sacrococcygeal tumors treated in these clinical trials.
- Evaluate tumor-associated/surgical morbidity (sexual function/fertility) in patients
with malignant gonadal or pelvic GCTs.
- Evaluate tumor-associated/surgical morbidity (respiratory function) in patients with
- Develop a methodology and recommendations for the prospective late evaluation of
patients treated on future extracranial GCT clinical trials and those included in this
- Inform clinicians about the late effects of treatment of malignant GCTs and advise them
on what long-term care these patients require.
OUTLINE: This is a cohort, multicenter study.
Patients complete questionnaires about ototoxicity, bladder and bowel dysfunction, and
sexual function and fertility as appropriate. They also complete a health-related
quality-of-life questionnaire over 20 minutes.
Treating physicians complete a lower-limb and neurologic dysfunction questionnaire. Data
from myelodysplasia, second malignancy, ototoxicity, nephrotoxicity, and pulmonary toxicity
assessments are collected from the patient's treating physician.
PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.
Ototoxicity as measured by audiogram and Health Utilities Index in patients previously treated with cisplatin or carboplatin
Adam Glaser, MD
Leeds Cancer Centre at St. James's University Hospital