Trial Information

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

OBJECTIVES:

- 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
CCLG-GC-1989-01.

- 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
thoracic GCTs.

- Develop a methodology and recommendations for the prospective late evaluation of
patients treated on future extracranial GCT clinical trials and those included in this
study.

- 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.