Ignite Creation Date:
2024-05-05 @ 5:21 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00436774
Status:
UNKNOWN
Last Update Posted:
2013-08-12
First Post:
2007-02-15
Brief Title:
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
Sponsor:
Childrens Cancer and Leukaemia Group
Organization:
National Cancer Institute NCI
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2009-06
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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-associatedsurgical morbidity bladder bowel and lower limb function in patients with malignant sacrococcygeal tumors treated in these clinical trials
Evaluate tumor-associatedsurgical morbidity sexual functionfertility in patients with malignant gonadal or pelvic GCTs
Evaluate tumor-associatedsurgical 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 patients treating physician
PROJECTED ACCRUAL A total of 60 patients will be accrued for this study
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-associatedsurgical morbidity bladder bowel and lower limb function in patients with malignant sacrococcygeal tumors treated in these clinical trials
Evaluate tumor-associatedsurgical morbidity sexual functionfertility in patients with malignant gonadal or pelvic GCTs
Evaluate tumor-associatedsurgical 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 patients treating physician
PROJECTED ACCRUAL A total of 60 patients will be accrued for this study
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EU-20642 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000531140 | REGISTRY | None | None |