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
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
Conditions: official terms
Infertility - Neoplasms - Neoplasms, Germ Cell and Embryonal - Neurotoxicity Syndromes
Conditions: Keywords
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
Study Type
Observational
Study Phase
N/A
Study Design
N/A
Intervention
Name: assessment of therapy complications Type: Procedure
Name: quality-of-life assessment Type: Procedure
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 5 Years
Gender: Both
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
Locations
Our Lady's Hospital for Sick Children Crumlin
Dublin, Ireland
Status: Recruiting
Contact: Contact Person - 353-1-409-6653
Institute of Child Health at University of Bristol
Bristol, England, United Kingdom
Status: Recruiting
Contact: Contact Person - 44-117-342-8811
Addenbrooke's Hospital
Cambridge, England, United Kingdom
Status: Recruiting
Contact: Contact Person - 44-1223-256-298
Leeds Cancer Centre at St. James's University Hospital
Leeds, England, United Kingdom
Status: Recruiting
Contact: Adam Glaser, MD - 44-113-206-4984 - adam.glaser@leedsth.nhs.uk
Great Ormond Street Hospital for Children
London, England, United Kingdom
Status: Recruiting
Contact: Gill Levitt, MD - 44-20-7405-9200 ext. 0073
Sir James Spence Institute of Child Health at Royal Victoria Infirmary
Newcastle-Upon-Tyne, England, United Kingdom
Status: Recruiting
Contact: Juliet Hale, MD - 44-191-282-4101 - j.p.hale@ncl.ac.uk
Children's Hospital - Sheffield
Sheffield, England, United Kingdom
Status: Recruiting
Contact: Mary P. Gerrard, MBChB, FRCP, FRCPCH - 44-114-271-7366 - mary.gerrard@sch.nhs.uk
Southampton General Hospital
Southampton, England, United Kingdom
Status: Recruiting
Contact: Janice A. Kohler, MD, FRCP - 44-23-8079-6942
Royal Marsden - Surrey
Sutton, England, United Kingdom
Status: Recruiting
Contact: Mary Taj, MD - 44-20-8642-6011 ext. 1307
Royal Aberdeen Children's Hospital
Aberdeen, Scotland, United Kingdom
Status: Recruiting
Contact: Veronica Neefjes - 44-1224-550-217
Royal Hospital for Sick Children
Edinburgh, Scotland, United Kingdom
Status: Recruiting
Contact: W. Hamish Wallace, MD - 44-131-536-0426
Royal Hospital for Sick Children
Glasgow, Scotland, United Kingdom
Status: Recruiting
Contact: Milind D. Ronghe, MD - 44-141-201-9309
Childrens Hospital for Wales
Cardiff, Wales, United Kingdom
Status: Recruiting
Contact: Heidi Traunecker, MD, PhD - 44-29-2074-2285 - heidi.traunecker@cardiffandvale.wales.nhs.uk
Start Date
June 2006
Sponsors
Children's Cancer and Leukaemia Group
Source
National Cancer Institute (NCI)
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page