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
Recruitment status was: Recruiting
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.
Childhood Germ Cell Tumor
Extragonadal Germ Cell Tumor
Long-term Effects Secondary to Cancer Therapy in Children
Procedure: assessment of therapy complications
Procedure: quality-of-life assessment
|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|
- Ototoxicity as measured by audiogram and Health Utilities Index in patients previously treated with cisplatin or carboplatin [ Designated as safety issue: Yes ]
- Nephrotoxicity as measured by serum magnesium, calcium, and creatinine and glomerular filtration rate in patients previously treated with cisplatin or carboplatin [ Designated as safety issue: Yes ]
- Myelodysplasia and second malignancies in patients previously treated with etoposide [ Designated as safety issue: No ]
- Pulmonary toxicity as measured by lung function test and respiratory symptom questionnaire in patients previously treated with bleomycin [ Designated as safety issue: Yes ]
- 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 [ Designated as safety issue: No ]
- Quality of life (QOL) as measured by pediatric cancer quality-of-life inventory or Short Form 36 questionnaires [ Designated as safety issue: No ]
|Study Start Date:||June 2006|
|Estimated Primary Completion Date:||September 2010 (Final data collection date for primary outcome measure)|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00436774
|Our Lady's Hospital for Sick Children Crumlin|
|Dublin, Ireland, 12|
|Institute of Child Health at University of Bristol|
|Bristol, England, United Kingdom, BS2 8AE|
|Cambridge, England, United Kingdom, CB2 2QQ|
|Leeds Cancer Centre at St. James's University Hospital|
|Leeds, England, United Kingdom, LS9 7TF|
|Great Ormond Street Hospital for Children|
|London, England, United Kingdom, WC1N 3JH|
|Sir James Spence Institute of Child Health at Royal Victoria Infirmary|
|Newcastle-Upon-Tyne, England, United Kingdom, NE1 4LP|
|Children's Hospital - Sheffield|
|Sheffield, England, United Kingdom, S10 2TH|
|Southampton General Hospital|
|Southampton, England, United Kingdom, SO16 6YD|
|Royal Marsden - Surrey|
|Sutton, England, United Kingdom, SM2 5PT|
|Royal Aberdeen Children's Hospital|
|Aberdeen, Scotland, United Kingdom, AB25 2ZG|
|Royal Hospital for Sick Children|
|Edinburgh, Scotland, United Kingdom, EH9 1LF|
|Royal Hospital for Sick Children|
|Glasgow, Scotland, United Kingdom, G3 8SJ|
|Childrens Hospital for Wales|
|Cardiff, Wales, United Kingdom, CF14 4XW|
|Study Chair:||Adam Glaser, MD||Leeds Cancer Centre at St. James's University Hospital|