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

Children's Cancer and Leukaemia Group

Status: Unknown

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

Treatments: Procedure: quality-of-life assessment; Procedure: assessment of therapy complications

Study type: Observational

Funder types: Other

Identifiers

NCT00436774

CDR0000531140 (Registry Identifier)

EU-20642

CCLG-GC-2006-06

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 5+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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