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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
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.
Age
5 - No limit years
Sex
ALL
Healthy Volunteers
No
Our Lady's Hospital for Sick Children Crumlin
Dublin, Ireland
Institute of Child Health at University of Bristol
Bristol, England, United Kingdom
Addenbrooke's Hospital
Cambridge, England, United Kingdom
Leeds Cancer Centre at St. James's University Hospital
Leeds, England, United Kingdom
Great Ormond Street Hospital for Children
London, England, United Kingdom
Sir James Spence Institute of Child Health at Royal Victoria Infirmary
Newcastle upon Tyne, England, United Kingdom
Children's Hospital - Sheffield
Sheffield, England, United Kingdom
Southampton General Hospital
Southampton, England, United Kingdom
Royal Marsden - Surrey
Sutton, England, United Kingdom
Royal Aberdeen Children's Hospital
Aberdeen, Scotland, United Kingdom
Start Date
June 1, 2006
Primary Completion Date
September 1, 2010
Last Updated
August 12, 2013
60
ESTIMATED participants
assessment of therapy complications
PROCEDURE
quality-of-life assessment
PROCEDURE
Lead Sponsor
Children's Cancer and Leukaemia Group
NCT00716976
NCT01433224
Data Source & Attribution
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