Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00053352
Status:
COMPLETED
Last Update Posted:
2021-07-13
First Post:
2003-01-27
Brief Title:
Surgery and Combination Chemotherapy in Treating Children With Extracranial Germ Cell Tumors
Sponsor:
Childrens Oncology Group
Organization:
Childrens Oncology Group
Study Overview
Official Title:
A Phase III Study Of Reduced Therapy In The Treatment Of Children With Low And Intermediate Risk Extracranial Germ Cell Tumors
Status:
COMPLETED
Status Verified Date:
2021-07
Last Known Status:
None
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:
This phase III trial is studying surgery followed by combination chemotherapy to see how well it works in treating children with germ cell tumors that are not located in the head Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Combining more than one drug and giving them after surgery may kill any remaining tumor cells following surgery It is not yet known whether combination chemotherapy is effective in decreasing the recurrence of childhood germ cell tumors
Detailed Description:
OBJECTIVES
I Determine whether children with newly diagnosed low- or intermediate-risk extracranial germ cell tumors GCTs can maintain a 3-year event-free survival of at least 92 for intermediate-risk tumors only and overall survival of at least 95 both low-risk and intermediate-risk tumors after treatment with surgery followed by compressed cisplatin etoposide and bleomycin low-risk disease closed to accrual as of 012010
II Determine the percentage of patients with stage I ovarian or stage I testicular GCTs for whom chemotherapy can be eliminated
III Determine the percentage of intermediate-risk patients who require only 3 courses of therapy
IV Determine the acute toxic effects of compressed therapy in these patients V Determine the long-term sequelae in patients treated with this regimen VI Determine the number of hospital days and total drug doses required for patients treated with compressed therapy
VII Compare the number of protocol-directed treatment days used in CCG-8882 vs the number of treatment days used in this study
VIII Determine the cytogenetic and molecular genetic features in patients treated with this regimen
OUTLINE Patients are stratified according to disease risk low vs intermediate
SURGERY Patients undergo surgical resection
Low-risk disease Patients with gonadal primaries and no evidence of disease after surgery undergo monitoring for disease progression Patients who remain disease free receive no further treatment Patients who have disease progression after surgery receive compressed induction chemotherapy closed to accrual as of 01202010
Intermediate-risk disease After surgery patients proceed to compressed induction chemotherapy
COMPRESSED INDUCTION CHEMOTHERAPY Patients receive cisplatin IV over 90 minutes and etoposide IV over 90 minutes on days 1-3 and bleomycin IV over 10 minutes on day 1 Treatment repeats every 3 weeks for 3 courses weeks 0 3 and 6
After completion of compressed induction chemotherapy patients who have no change in disease status or disease progression are removed from study Patients with no evidence of disease receive no further therapy Patients with a partial response or who have abnormal tumor markers proceed to second-look surgery andor 3 more courses of compressed consolidation chemotherapy
SECOND-LOOK SURGERY Patients undergo surgical resection of residual tumor After surgery patients who are in pathologic complete response and have normal tumor markers receive no further therapy Patients who remain with a partial response after surgery receive compressed consolidation chemotherapy
COMPRESSED CONSOLIDATION CHEMOTHERAPY Patients receive cisplatin etoposide and bleomycin as in induction chemotherapy in weeks 10 13 and 16
Patients are followed up monthly for 6 months every 3 months for 18 months and then annually for up to 10 years
I Determine whether children with newly diagnosed low- or intermediate-risk extracranial germ cell tumors GCTs can maintain a 3-year event-free survival of at least 92 for intermediate-risk tumors only and overall survival of at least 95 both low-risk and intermediate-risk tumors after treatment with surgery followed by compressed cisplatin etoposide and bleomycin low-risk disease closed to accrual as of 012010
II Determine the percentage of patients with stage I ovarian or stage I testicular GCTs for whom chemotherapy can be eliminated
III Determine the percentage of intermediate-risk patients who require only 3 courses of therapy
IV Determine the acute toxic effects of compressed therapy in these patients V Determine the long-term sequelae in patients treated with this regimen VI Determine the number of hospital days and total drug doses required for patients treated with compressed therapy
VII Compare the number of protocol-directed treatment days used in CCG-8882 vs the number of treatment days used in this study
VIII Determine the cytogenetic and molecular genetic features in patients treated with this regimen
OUTLINE Patients are stratified according to disease risk low vs intermediate
SURGERY Patients undergo surgical resection
Low-risk disease Patients with gonadal primaries and no evidence of disease after surgery undergo monitoring for disease progression Patients who remain disease free receive no further treatment Patients who have disease progression after surgery receive compressed induction chemotherapy closed to accrual as of 01202010
Intermediate-risk disease After surgery patients proceed to compressed induction chemotherapy
COMPRESSED INDUCTION CHEMOTHERAPY Patients receive cisplatin IV over 90 minutes and etoposide IV over 90 minutes on days 1-3 and bleomycin IV over 10 minutes on day 1 Treatment repeats every 3 weeks for 3 courses weeks 0 3 and 6
After completion of compressed induction chemotherapy patients who have no change in disease status or disease progression are removed from study Patients with no evidence of disease receive no further therapy Patients with a partial response or who have abnormal tumor markers proceed to second-look surgery andor 3 more courses of compressed consolidation chemotherapy
SECOND-LOOK SURGERY Patients undergo surgical resection of residual tumor After surgery patients who are in pathologic complete response and have normal tumor markers receive no further therapy Patients who remain with a partial response after surgery receive compressed consolidation chemotherapy
COMPRESSED CONSOLIDATION CHEMOTHERAPY Patients receive cisplatin etoposide and bleomycin as in induction chemotherapy in weeks 10 13 and 16
Patients are followed up monthly for 6 months every 3 months for 18 months and then annually for up to 10 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U10CA098543 | NIH | Childrens Oncology Group | httpsreporternihgovquickSearchU10CA098543 |
| NCI-2009-00373 | REGISTRY | None | None |
| CDR0000269433 | OTHER | None | None |
| COG-AGCT0132 | OTHER | None | None |