NCT00436774

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

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 60 (estimated)
• Sponsor: Children's Cancer and Leukaemia Group · Academic / Other
• Sex: All
• Age: 5 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• 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

Interventions

Type	Name	Description
PROCEDURE	assessment of therapy complications
PROCEDURE	quality-of-life assessment

Timeline

• Start date: 2006-06-01
• Primary completion: 2010-09-01
• First posted: 2007-02-19
• Last updated: 2013-08-12

Locations

13 sites across 2 countries: Ireland, United Kingdom