Treatment Outcome and Quality of Life in Patients With Pediatric Extra-Cranial Germ Cell Tumors Previously Treated on Clinical Trial CCLG-GC-1979-01 or CCLG-GC-1989-01

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Childhood Germ Cell Tumor, Extragonadal Germ Cell Tumor, Gastrointestinal Complications, Infertility, Long-term Effects Secondary to Cancer Therapy in Children, Neurotoxicity, Ovarian Cancer, Pulmonary Complications, Sexual Dysfunction, Urinary Complications

Intervention / Treatment
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* Procedure: assessment of therapy complications
* Procedure: quality-of-life assessment


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Previously enrolled in 1 of the following United Kingdom Children's Cancer Study Group (UKCCSG) clinical trials for treatment of extracranial germ cell tumors: CCLG-GC-1989-01 CCLG-GC-1979-01 Received bleomycin or cisplatin therapy At least 5 years since completion of therapy in these clinical trials Attending or in contact with a UKCCSG center Patients treated for sacrococcygeal teratomas and discharged from follow-up are eligible No recurrent or progressive disease PATIENT CHARACTERISTICS: No patient deemed unsuitable for this study by the treating clinician PRIOR CONCURRENT THERAPY: See Disease Characteristics

Ages Eligible for Study
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Minimum Age: 5 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: assessment of therapy complications|nan|
|Procedure: quality-of-life assessment|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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long-term effects secondary to cancer therapy in children, neurotoxicity, gastrointestinal complications, pulmonary complications, sexual dysfunction, infertility, urinary complications, childhood extragonadal germ cell tumor, childhood malignant ovarian germ cell tumor, childhood malignant testicular germ cell tumor, childhood teratoma