RATIONALE: Treatment for pediatric extracranial germ cell tumors may cause side effects and secondary cancers later in life. A study that evaluates patients after receiving combination chemotherapy or surgery may help doctors understand the side effects and secondary cancers that occur later in life. PURPOSE: This study is looking at treatment outcome and quality of life in patients with pediatric extracranial germ cell tumors previously treated on clinical trial CCLG-GC-1979-01 or CCLG-GC-1989-01.
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.
Study Type
OBSERVATIONAL
Enrollment
60
Our Lady's Hospital for Sick Children Crumlin
Dublin, Ireland
RECRUITINGInstitute of Child Health at University of Bristol
Bristol, England, United Kingdom
RECRUITINGAddenbrooke's Hospital
Cambridge, England, United Kingdom
RECRUITINGLeeds Cancer Centre at St. James's University Hospital
Leeds, England, United Kingdom
RECRUITINGGreat Ormond Street Hospital for Children
London, England, United Kingdom
RECRUITINGSir James Spence Institute of Child Health at Royal Victoria Infirmary
Newcastle upon Tyne, England, United Kingdom
RECRUITINGChildren's Hospital - Sheffield
Sheffield, England, United Kingdom
RECRUITINGSouthampton General Hospital
Southampton, England, United Kingdom
RECRUITINGRoyal Marsden - Surrey
Sutton, England, United Kingdom
RECRUITINGRoyal Aberdeen Children's Hospital
Aberdeen, Scotland, United Kingdom
RECRUITING...and 3 more locations
Ototoxicity as measured by audiogram and Health Utilities Index in patients previously treated with cisplatin or carboplatin
Nephrotoxicity as measured by serum magnesium, calcium, and creatinine and glomerular filtration rate in patients previously treated with cisplatin or carboplatin
Myelodysplasia and second malignancies in patients previously treated with etoposide
Pulmonary toxicity as measured by lung function test and respiratory symptom questionnaire in patients previously treated with bleomycin
Bladder and bowel dysfunction, sexual function, and fertility as measured by patient-completed questionnaires and lower limb and neurological dysfunction as measured by clinician-completed questionnaires in patients with pelvic or sacrococcygeal tumors
Quality of life (QOL) as measured by pediatric cancer quality-of-life inventory or Short Form 36 questionnaires
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