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
|ClinicalTrials.gov Identifier: NCT00436774|
Recruitment Status : Unknown
Verified June 2009 by National Cancer Institute (NCI).
Recruitment status was: Recruiting
First Posted : February 19, 2007
Last Update Posted : August 12, 2013
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.
|Condition or disease||Intervention/treatment|
|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||Procedure: assessment of therapy complications Procedure: quality-of-life assessment|
- 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 Type :||Observational|
|Estimated Enrollment :||60 participants|
|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|
|Study Start Date :||June 2006|
|Estimated Primary Completion Date :||September 2010|
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00436774
|Our Lady's Hospital for Sick Children Crumlin||Recruiting|
|Dublin, Ireland, 12|
|Contact: Contact Person 353-1-409-6653|
|Institute of Child Health at University of Bristol||Recruiting|
|Bristol, England, United Kingdom, BS2 8AE|
|Contact: Contact Person 44-117-342-8811|
|Cambridge, England, United Kingdom, CB2 2QQ|
|Contact: Contact Person 44-1223-256-298|
|Leeds Cancer Centre at St. James's University Hospital||Recruiting|
|Leeds, England, United Kingdom, LS9 7TF|
|Contact: Adam Glaser, MD 44-113-206-4984 firstname.lastname@example.org|
|Great Ormond Street Hospital for Children||Recruiting|
|London, England, United Kingdom, WC1N 3JH|
|Contact: Gill Levitt, MD 44-20-7405-9200 ext. 0073|
|Sir James Spence Institute of Child Health at Royal Victoria Infirmary||Recruiting|
|Newcastle-Upon-Tyne, England, United Kingdom, NE1 4LP|
|Contact: Juliet Hale, MD 44-191-282-4101 email@example.com|
|Children's Hospital - Sheffield||Recruiting|
|Sheffield, England, United Kingdom, S10 2TH|
|Contact: Mary P. Gerrard, MBChB, FRCP, FRCPCH 44-114-271-7366 firstname.lastname@example.org|
|Southampton General Hospital||Recruiting|
|Southampton, England, United Kingdom, SO16 6YD|
|Contact: Janice A. Kohler, MD, FRCP 44-23-8079-6942|
|Royal Marsden - Surrey||Recruiting|
|Sutton, England, United Kingdom, SM2 5PT|
|Contact: Mary Taj, MD 44-20-8642-6011 ext. 1307|
|Royal Aberdeen Children's Hospital||Recruiting|
|Aberdeen, Scotland, United Kingdom, AB25 2ZG|
|Contact: Veronica Neefjes 44-1224-550-217|
|Royal Hospital for Sick Children||Recruiting|
|Edinburgh, Scotland, United Kingdom, EH9 1LF|
|Contact: W. Hamish Wallace, MD 44-131-536-0426|
|Royal Hospital for Sick Children||Recruiting|
|Glasgow, Scotland, United Kingdom, G3 8SJ|
|Contact: Milind D. Ronghe, MD 44-141-201-9309|
|Childrens Hospital for Wales||Recruiting|
|Cardiff, Wales, United Kingdom, CF14 4XW|
|Contact: Heidi Traunecker, MD, PhD 44-29-2074-2285 email@example.com|
|Study Chair:||Adam Glaser, MD||Leeds Cancer Centre at St. James's University Hospital|