Ignite Creation Date:
2024-05-05 @ 4:36 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00274950
Status:
UNKNOWN
Last Update Posted:
2013-09-17
First Post:
2006-01-10
Brief Title:
Observation andor Combination Chemotherapy After Surgery or Biopsy in Treating Young Patients With Extracranial Germ Cell Tumors
Sponsor:
Childrens Cancer and Leukaemia Group
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Protocol for the Treatment of Extracranial Germ Cell Tumours in Children and Adolescents GC III
Status:
UNKNOWN
Status Verified Date:
2009-06
Last Known Status:
ACTIVE_NOT_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 Sometimes after surgery the tumor may not need additional treatment until it progresses In this case observation may be sufficient Drugs used in chemotherapy work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Giving more than one drug combination chemotherapy may kill more tumor cells Giving combination chemotherapy after surgery may kill any remaining tumor cells
PURPOSE This phase III trial is studying how well observation andor combination chemotherapy works after surgery or biopsy in treating young patients with extracranial germ cell tumors
PURPOSE This phase III trial is studying how well observation andor combination chemotherapy works after surgery or biopsy in treating young patients with extracranial germ cell tumors
Detailed Description:
OBJECTIVES
Stratify and reduce treatment for pediatric patients with extracranial germ cell tumors while maintaining event-free survival
Treat newly diagnosed patients with extracranial germ cell tumors requiring chemotherapy with a carboplatin-based strategy
Develop a common strategy for the treatment of patients with recurrent or progressive extracranial germ cell tumors
Register all cases of mature and immature teratoma
Develop a common strategy for the management of immature and mature teratoma including follow-up strategies to permit early detection of yolk sac recurrence
OUTLINE This is a multicenter study
Patients who have not had prior biopsy or surgical resection undergo biopsy if feasible or surgical resection Patients with mature or immature teratoma undergo observation These patients who relapse ie tumor regrowth may undergo further surgical resection unless tumor markers are significantly elevated If the tumor markers are significantly elevated these patients proceed to JEB chemotherapy according to risk group Patients with all other malignant germ cell tumors are assigned to 1 of 3 treatment groups according to risk
Low-risk group Patients with normal tumor markers undergo observation Patients with rising tumor markers only AND no imageable tumor proceed to treatment as in the intermediate-risk group Patients with rising tumor markers ANDOR imageable tumor are considered to have relapsed and proceed to treatment as in the intermediate- or high-risk group
Intermediate-risk group Patients receive JEB chemotherapy comprising etoposide IV over 4 hours on days 1-3 carboplatin IV over 1 hour on day 2 and bleomycin IV over 30 minutes on day 3 Treatment repeats every 21 days for 4 courses Patients with residual tumors after completion of chemotherapy may undergo second-look surgery
High-risk group Patients receive JEB chemotherapy as in the intermediate-risk group for 6 courses Patients with residual tumors after completion of chemotherapy may undergo second-look surgery
Relapse therapy Patients in the intermediate- or high-risk group who relapse after completion of JEB chemotherapy receive vinblastine IV on days 1 and 2 ifosfamide IV over 1 hour on days 1-5 and cisplatin IV on days 1-5 Treatment repeats every 21 days for 6 courses
PROJECTED ACCRUAL A total of 105 patients will be accrued for this study
Stratify and reduce treatment for pediatric patients with extracranial germ cell tumors while maintaining event-free survival
Treat newly diagnosed patients with extracranial germ cell tumors requiring chemotherapy with a carboplatin-based strategy
Develop a common strategy for the treatment of patients with recurrent or progressive extracranial germ cell tumors
Register all cases of mature and immature teratoma
Develop a common strategy for the management of immature and mature teratoma including follow-up strategies to permit early detection of yolk sac recurrence
OUTLINE This is a multicenter study
Patients who have not had prior biopsy or surgical resection undergo biopsy if feasible or surgical resection Patients with mature or immature teratoma undergo observation These patients who relapse ie tumor regrowth may undergo further surgical resection unless tumor markers are significantly elevated If the tumor markers are significantly elevated these patients proceed to JEB chemotherapy according to risk group Patients with all other malignant germ cell tumors are assigned to 1 of 3 treatment groups according to risk
Low-risk group Patients with normal tumor markers undergo observation Patients with rising tumor markers only AND no imageable tumor proceed to treatment as in the intermediate-risk group Patients with rising tumor markers ANDOR imageable tumor are considered to have relapsed and proceed to treatment as in the intermediate- or high-risk group
Intermediate-risk group Patients receive JEB chemotherapy comprising etoposide IV over 4 hours on days 1-3 carboplatin IV over 1 hour on day 2 and bleomycin IV over 30 minutes on day 3 Treatment repeats every 21 days for 4 courses Patients with residual tumors after completion of chemotherapy may undergo second-look surgery
High-risk group Patients receive JEB chemotherapy as in the intermediate-risk group for 6 courses Patients with residual tumors after completion of chemotherapy may undergo second-look surgery
Relapse therapy Patients in the intermediate- or high-risk group who relapse after completion of JEB chemotherapy receive vinblastine IV on days 1 and 2 ifosfamide IV over 1 hour on days 1-5 and cisplatin IV on days 1-5 Treatment repeats every 21 days for 6 courses
PROJECTED ACCRUAL A total of 105 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-20584 | None | None | None |
| CCLG-GC-2005-04 | None | None | None |
| EUDRACT-2004-002503-33 | None | None | None |