Ignite Creation Date:
2024-05-05 @ 4:40 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00293358
Status:
COMPLETED
Last Update Posted:
2013-09-17
First Post:
2006-02-16
Brief Title:
Combination Chemotherapy and Radiation Therapy in Treating Patients With Germ Cell Tumors in the Brain
Sponsor:
Childrens Cancer and Leukaemia Group
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
SIOP Intracranial Germ Cell Tumours Protocol
Status:
COMPLETED
Status Verified Date:
2008-07
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:
RATIONALE Drugs used in chemotherapy such as carboplatin etoposide ifosfamide and cisplatin work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Radiation therapy uses high-energy x-rays to kill tumor cells Giving more than one drug combination chemotherapy with radiation therapy may kill more tumor cells
PURPOSE This phase III trial is studying combination chemotherapy followed by radiation therapy to see how well it works compared to radiation therapy alone in treating patients with germ cell tumors in the brain
PURPOSE This phase III trial is studying combination chemotherapy followed by radiation therapy to see how well it works compared to radiation therapy alone in treating patients with germ cell tumors in the brain
Detailed Description:
OBJECTIVES
Primary
Evaluate and compare in a non-randomized protocol reduced-dose craniospinal radiotherapy alone or combination chemotherapy comprising carboplatin etoposide phosphate and ifosfamide and local irradiation in patients with intracranial germinoma
Increase survival with combination chemotherapy comprising cisplatin etoposide phosphate and ifosfamide followed by focal radiotherapy or craniospinal irradiation in patients with intracranial secreting germ cell tumors
Secondary
Use the same diagnostic protocol for imaging and laboratory investigations before during and after treatment
Establish and use a common documentation system regarding general patients data including diagnostic tests clinical evaluation surgery histology radiotherapy chemotherapy and toxicity
Collect information about toxicity prognostic factors and tumor markers
Collect epidemiological data including documentation of incidence and the site and the histologic pattern of intracranial secreting and nonsecreting germ cell tumors in children and adolescents
Register associated malformations in the patients as well as the epidemiology of tumors and malformations in relatives
OUTLINE This is a non-randomized multicenter study Patients are stratified according to tumor classification pure CNS germinoma vs secreting germ cell tumor and embryonal carcinoma
Patients in stratum I undergo biopsy or surgical resection and then begin radiotherapy with or without chemotherapy
Stratum I pure CNS germinoma without elevated markers Patients receive 1 of 2 treatment options based on nationalcenter standard
Option 1 Patients receive reduced-dose craniospinal radiotherapy 5 days a week for 3 weeks followed by a boost to the tumor bed 5 days a week for 2 weeks Patients with multifocal or metastatic disease receive additional boosts to the tumor sites
Option 2 Patients receive carboplatin IV over 1 hour on day 1 etoposide phosphate IV over 1 hour on days 1-3 and 22-24 and ifosfamide IV over 3 hours on days 22-26 Treatment repeats every 6 weeks for 2 courses After recovery from chemotherapy patients undergo radiotherapy 5 days a week for 5 weeks
Stratum II secreting tumors and embryonal carcinoma Patients receive etoposide phosphate IV over 1 hour on days 1-3 cisplatin IV over 1 hour on days 1-5 and ifosfamide IV over 22 hours on days 1-5 Treatment repeats every 3 weeks for up to 4 courses Patients whose tumor markers do not return to normal after completion of chemotherapy are off protocol Patients may undergo surgery after chemotherapy course 2 or 4 if required After completion of chemotherapy and recovery from surgery patients with nonmetastatic disease undergo radiotherapy to the tumor bed 5 day a week for 6 weeks and patients with metastatic disease undergo radiotherapy to the cerebrum spinal axis and tumor bed for 7 weeks
After completion of study treatment patients are followed for 4 weeks and then periodically
PROJECTED ACCRUAL Approximately 500 patients will be accrued for this study
Primary
Evaluate and compare in a non-randomized protocol reduced-dose craniospinal radiotherapy alone or combination chemotherapy comprising carboplatin etoposide phosphate and ifosfamide and local irradiation in patients with intracranial germinoma
Increase survival with combination chemotherapy comprising cisplatin etoposide phosphate and ifosfamide followed by focal radiotherapy or craniospinal irradiation in patients with intracranial secreting germ cell tumors
Secondary
Use the same diagnostic protocol for imaging and laboratory investigations before during and after treatment
Establish and use a common documentation system regarding general patients data including diagnostic tests clinical evaluation surgery histology radiotherapy chemotherapy and toxicity
Collect information about toxicity prognostic factors and tumor markers
Collect epidemiological data including documentation of incidence and the site and the histologic pattern of intracranial secreting and nonsecreting germ cell tumors in children and adolescents
Register associated malformations in the patients as well as the epidemiology of tumors and malformations in relatives
OUTLINE This is a non-randomized multicenter study Patients are stratified according to tumor classification pure CNS germinoma vs secreting germ cell tumor and embryonal carcinoma
Patients in stratum I undergo biopsy or surgical resection and then begin radiotherapy with or without chemotherapy
Stratum I pure CNS germinoma without elevated markers Patients receive 1 of 2 treatment options based on nationalcenter standard
Option 1 Patients receive reduced-dose craniospinal radiotherapy 5 days a week for 3 weeks followed by a boost to the tumor bed 5 days a week for 2 weeks Patients with multifocal or metastatic disease receive additional boosts to the tumor sites
Option 2 Patients receive carboplatin IV over 1 hour on day 1 etoposide phosphate IV over 1 hour on days 1-3 and 22-24 and ifosfamide IV over 3 hours on days 22-26 Treatment repeats every 6 weeks for 2 courses After recovery from chemotherapy patients undergo radiotherapy 5 days a week for 5 weeks
Stratum II secreting tumors and embryonal carcinoma Patients receive etoposide phosphate IV over 1 hour on days 1-3 cisplatin IV over 1 hour on days 1-5 and ifosfamide IV over 22 hours on days 1-5 Treatment repeats every 3 weeks for up to 4 courses Patients whose tumor markers do not return to normal after completion of chemotherapy are off protocol Patients may undergo surgery after chemotherapy course 2 or 4 if required After completion of chemotherapy and recovery from surgery patients with nonmetastatic disease undergo radiotherapy to the tumor bed 5 day a week for 6 weeks and patients with metastatic disease undergo radiotherapy to the cerebrum spinal axis and tumor bed for 7 weeks
After completion of study treatment patients are followed for 4 weeks and then periodically
PROJECTED ACCRUAL Approximately 500 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 |
|---|---|---|---|
| CCLG-GC-1997-01 | None | None | None |
| EU-20579 | None | None | None |
| SIOP-CNS-GCT-96 | None | None | None |