Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00085098
Status:
COMPLETED
Last Update Posted:
2018-09-07
First Post:
2004-06-10
Brief Title:
Radiation Therapy Compared With Chemotherapy and Radiation Therapy in Treating Patients With Newly Diagnosed Primary Central Nervous System CNS Germ Cell Tumor
Sponsor:
Childrens Oncology Group
Organization:
Childrens Oncology Group
Study Overview
Official Title:
Radiotherapy Alone Versus Chemotherapy Followed By Response-Based Radiotherapy For Newly Diagnosed Primary CNS Germinoma
Status:
COMPLETED
Status Verified Date:
2018-08
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 Radiation therapy uses high-energy x-rays to damage tumor cells Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die It is not yet known whether radiation therapy alone is as effective as chemotherapy plus radiation therapy in treating germ cell tumor
PURPOSE This randomized phase III trial is studying radiation therapy alone to see how well it works compared to chemotherapy and radiation therapy in treating patients with newly diagnosed primary CNS germ cell tumor
PURPOSE This randomized phase III trial is studying radiation therapy alone to see how well it works compared to chemotherapy and radiation therapy in treating patients with newly diagnosed primary CNS germ cell tumor
Detailed Description:
OBJECTIVES
Primary
Compare event-free survival and overall survival of patients with newly diagnosed primary CNS germ cell tumor treated with conventional radiotherapy alone regimen A vs chemotherapy followed by tumor response-based radiotherapy regimen B
Secondary
Determine the complete response rate in patients treated with regimen B
Determine the acute and subacute toxicity of regimen B in these patients
Compare treatment-related morbidity in terms of verbal learning and memory executive functioning and quality of life in patients treated with these regimens
Determine the prognostic value of baseline serum lumbar and intraventricular levels of human chorionic gonadotropin levels from patients treated with these regimens
Determine the prognostic value of extent of disease M vs modified M vs M0 on event-free survival and overall survival of patients treated with these regimens
OUTLINE This is a randomized multicenter study Patients are stratified according to tumor location pineal vs suprasellar vs pineal suprasellar or other and disease stage disseminated vs occult multi-focal vs localized Patients are randomized to 1 of 2 treatment regimens
All patients undergo an operative procedure endoscopic biopsy stereotactic biopsy or open craniotomy to confirm the diagnosis of pure germ cell germinoma followed by an intraoperative and perioperative staging evaluation
Regimen A radiotherapy only Within 52 days of surgery patients undergo standard-dose radiotherapy once daily on days 1-5 for approximately 5-6 weeks
Regimen B chemotherapy plus radiotherapy
Courses 1 and 2 Patients receive carboplatin IV over 1 hour on days 1 and 2 and etoposide IV over 2 hours on days 1-3 Treatment repeats every 21 days for 2 courses
Patients achieving a complete response CR proceed to reduced-dose radiotherapy Patients with minimal residual disease MRD a partial response PR or stable disease SD receive chemotherapy courses 3 and 4 as outlined below Patients with progressive disease undergo a second surgical procedure for biopsy and are restaged Patients with a confirmed diagnosis of germ cell tumor with no change in tumor markers and no new lesions after restaging proceed to chemotherapy courses 3 and 4
Courses 3 and 4 Patients receive cisplatin IV over 6 hours on day 1 cyclophosphamide IV over 1 hour on days 2 and 3 and filgrastim G-CSF subcutaneously or IV beginning on day 4 and continuing until blood counts recover Treatment repeats every 21 days for 2 courses
Patients achieving a CR or MRD proceed to reduced-dose radiotherapy Patients with a PR SD or progressive disease are restaged Patients with a confirmed diagnosis of germ cell tumor after restaging undergo standard radiotherapy as in regimen A
Reduced-dose radiotherapy Within 6 weeks of starting course 4 patients undergo lower-dose radiotherapy once daily on days 1-5 for 5 weeks
Treatment in both regimens continues in the absence of unacceptable toxicity or in the event that a non-germinomatous germ cell tumor is detected
Quality of life and neuropsychological function within the domains of intelligence attention-concentration memory and executive functioning are assessed at 9 30 and 60 months after diagnosis
Patients are followed every 4 months for 2 years and then annually thereafter
PROJECTED ACCRUAL A total of 225 patients approximately 112 per treatment regimen will be accrued for this study within 5 years
Primary
Compare event-free survival and overall survival of patients with newly diagnosed primary CNS germ cell tumor treated with conventional radiotherapy alone regimen A vs chemotherapy followed by tumor response-based radiotherapy regimen B
Secondary
Determine the complete response rate in patients treated with regimen B
Determine the acute and subacute toxicity of regimen B in these patients
Compare treatment-related morbidity in terms of verbal learning and memory executive functioning and quality of life in patients treated with these regimens
Determine the prognostic value of baseline serum lumbar and intraventricular levels of human chorionic gonadotropin levels from patients treated with these regimens
Determine the prognostic value of extent of disease M vs modified M vs M0 on event-free survival and overall survival of patients treated with these regimens
OUTLINE This is a randomized multicenter study Patients are stratified according to tumor location pineal vs suprasellar vs pineal suprasellar or other and disease stage disseminated vs occult multi-focal vs localized Patients are randomized to 1 of 2 treatment regimens
All patients undergo an operative procedure endoscopic biopsy stereotactic biopsy or open craniotomy to confirm the diagnosis of pure germ cell germinoma followed by an intraoperative and perioperative staging evaluation
Regimen A radiotherapy only Within 52 days of surgery patients undergo standard-dose radiotherapy once daily on days 1-5 for approximately 5-6 weeks
Regimen B chemotherapy plus radiotherapy
Courses 1 and 2 Patients receive carboplatin IV over 1 hour on days 1 and 2 and etoposide IV over 2 hours on days 1-3 Treatment repeats every 21 days for 2 courses
Patients achieving a complete response CR proceed to reduced-dose radiotherapy Patients with minimal residual disease MRD a partial response PR or stable disease SD receive chemotherapy courses 3 and 4 as outlined below Patients with progressive disease undergo a second surgical procedure for biopsy and are restaged Patients with a confirmed diagnosis of germ cell tumor with no change in tumor markers and no new lesions after restaging proceed to chemotherapy courses 3 and 4
Courses 3 and 4 Patients receive cisplatin IV over 6 hours on day 1 cyclophosphamide IV over 1 hour on days 2 and 3 and filgrastim G-CSF subcutaneously or IV beginning on day 4 and continuing until blood counts recover Treatment repeats every 21 days for 2 courses
Patients achieving a CR or MRD proceed to reduced-dose radiotherapy Patients with a PR SD or progressive disease are restaged Patients with a confirmed diagnosis of germ cell tumor after restaging undergo standard radiotherapy as in regimen A
Reduced-dose radiotherapy Within 6 weeks of starting course 4 patients undergo lower-dose radiotherapy once daily on days 1-5 for 5 weeks
Treatment in both regimens continues in the absence of unacceptable toxicity or in the event that a non-germinomatous germ cell tumor is detected
Quality of life and neuropsychological function within the domains of intelligence attention-concentration memory and executive functioning are assessed at 9 30 and 60 months after diagnosis
Patients are followed every 4 months for 2 years and then annually thereafter
PROJECTED ACCRUAL A total of 225 patients approximately 112 per treatment regimen will be accrued for this study within 5 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 |
|---|---|---|---|
| COG-ACNS0232 | OTHER | Childrens Oncology Group | None |
| CDR0000367294 | OTHER | None | None |