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
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 12
- 主要终点
- Ototoxicity as measured by audiogram and Health Utilities Index in patients previously treated with cisplatin or carboplatin
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 5 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
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
次要结局
未报告次要终点