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

Ovarian Cancer Clinical Trial

Official title: 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 Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

N/A

Related Conditions & MeSH terms

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

• NCT number: NCT00436774
• Study type: Observational
• Source: National Cancer Institute (NCI)
• Status: Recruiting
• Phase: N/A
• Start date: June 2006