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
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|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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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 email@example.com|
|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 firstname.lastname@example.org|
|Children's Hospital - Sheffield||Recruiting|
|Sheffield, England, United Kingdom, S10 2TH|
|Contact: Mary P. Gerrard, MBChB, FRCP, FRCPCH 44-114-271-7366 email@example.com|
|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 firstname.lastname@example.org|
|Study Chair:||Adam Glaser, MD||Leeds Cancer Centre at St. James's University Hospital|