Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06368817
Status:
RECRUITING
Last Update Posted:
2024-07-08
First Post:
2024-04-08
Brief Title:
A Study of Lower Radiotherapy Dose to Treat Children With CNS Germinoma
Sponsor:
Childrens Oncology Group
Organization:
Childrens Oncology Group
Study Overview
Official Title:
A Phase II Trial Evaluating Chemotherapy Followed by Response-Based Reduced Radiation Therapy for Patients With Central Nervous System Germinomas
Status:
RECRUITING
Status Verified Date:
2024-10
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 II trial studies how well lower dose radiotherapy after chemotherapy works in treating children with central nervous system CNS germinomas Radiation therapy uses high energy x-rays particles or radioactive seeds to kill cancer cells and shrink tumors Carboplatin is in a class of medications known as platinum-containing compounds It works in a way similar to the anticancer drug cisplatin but may be better tolerated than cisplatin Carboplatin works by killing stopping or slowing the growth of tumor cells Etoposide is in a class of medications known as podophyllotoxin derivatives It blocks a certain enzyme needed for cell division and DNA repair and may kill cancer cells Researchers want to see if lowering the dose of standard radiotherapy RT after chemotherapy can help get rid of CNS germinomas with fewer long-term side effects
Detailed Description:
PRIMARY OBJECTIVE
I To determine whether 12 Gy whole ventricular irradiation WVI and 12 Gy tumor boost would maintain similar efficacy compared to ACNS1123 stratum 2 as measured by event-free survival EFS in eligible patients with localized primary central nervous system CNS germinoma who present with serum andor cerebrospinal fluid CSF human chorionic gonadotropin-beta hCGbeta 100 IUL and normal alpha-fetoprotein AFP and meet complete response CR or continued complete response CCR criteria following chemotherapysecond-look surgery Stratum 1
SECONDARY OBJECTIVES
I To estimate the EFS distribution for patients with localized midline - including bifocal - CNS germinoma with partial response PR after chemotherapy followed by 18 Gy WVI and 12 Gy tumor boost Stratum 2
II To estimate the EFS distribution for patients with localized midline - including bifocal - CNS germinoma with less than a PR after chemotherapy followed by 24 Gy WVI and 12 Gy tumor boost Stratum 3
III To estimate the overall survival OS response rates to chemotherapy and radiotherapy RT as well as the patterns of failure of the various cohorts based on tumor characteristics treatment regimen and treatment modality
IV To determine the impact of tumor characteristics treatment regimen and treatment modalities on the long-term neuroendocrine function for patients with CNS germinomas
V To prospectively evaluate processing speed of children and young adults with CNS germinoma through the Childrens Oncology Group COG Standardized assessment battery
EXPLORATORY OBJECTIVES
I To estimate the EFS distribution for patients with metastatic germinomas treated with chemotherapy followed by craniospinal irradiation CSI 18 Gy for CRCCR Stratum 4 or 24 Gy for less than CR Stratum 5 with a 12 Gy tumor boost to the pre-treatment volume including metastatic sites
II To estimate the EFS distribution for patients with basal ganglia and thalamic germinomas BGTG treated with chemotherapy followed by whole brain irradiation WBI 18 Gy for CRCCR Stratum 6 or 24 Gy for less than CR Stratum 7 with a 12 Gy tumor boost to the pre-treatment volume
III To prospectively collect blood cerebrospinal fluid and tumor tissue at diagnosis and second-look surgery if feasible for future biology studies
IV To prospectively measure the incidence of cerebral vascular events stroke or transient ischemic attacks in the follow-up period and longitudinally evaluate and model the cognitive social and behavioral functioning of children and young adults with CNS germinoma through the COG Standardized assessment battery and compare these outcomes based on tumor characteristics treatment regimen and treatment modality
OUTLINE
INDUCTION PHASE All patients receive carboplatin intravenously IV over 15-60 minutes on day 1 and etoposide IV over 90-120 minutes on days 1-3 of each cycle Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity
Patients are then assigned to 1 of 7 strata
STRATUM I Patients with localized germinoma achieving CR with normalization of markers undergo 3-dimensional conformal radiation therapy 3DCRT or intensity-modulated radiation therapy IMRT once daily QD 5 days a week for 16 days Patients achieving PR with normalization of markers may undergo second-look surgery Patients found to have mature teratoma or non-viable tumor undergo 3DRT or IMRT QD 5 days a week for 16 days Patients with normalization of markers who fail to achieve CR or PR may undergo second-look surgery Patients found to have mature teratoma or non-viable tumor undergo 3DRT or IMRT QD 5 days a week for 16 days Patients with bifocal germinoma undergo 3DRT or IMRT QD 5 days a week for 16 days
STRATUM II Patients with localized germinoma achieving PR with normalization of markers who do not undergo second-look surgery undergo 3DRT or IMRT QD 5 days a week for 20 days
STRATUM III Patients with localized germinoma with normalization of markers who fail to achieve CR or PR who do not undergo second-look surgery undergo 3DRT or IMRT QD 5 days a week for 24 days
STRATUM IV Patients with metastatic germinoma achieving CR undergo 3DRT or IMRT QD 5 days a week for 20 days Patients with metastatic germinoma and normalization of markers who fail to achieve CR may undergo second-look surgery Patients found to have mature teratoma or non-viable tumor undergo 3DRT or IMRT QD 5 days a week for 20 days
STRATUM V Patients with metastatic germinoma with normalization of markers who fail to achieve CR who do not undergo second-look surgery undergo 3DRT or IMRT QD 5 days a week for 24 days
STRATUM VI Patients with basal ganglia and thalamic germinoma achieving CR undergo 3DRT or IMRT QD 5 days a week for 20 days Patients with basal ganglia and thalamic germinoma and normalization of markers who fail to achieve CR may undergo second-look surgery Patients found to have mature teratoma or non-viable tumor undergo 3DRT or IMRT QD 5 days a week for 20 days
STRATUM VII Patients with basal ganglia and thalamic germinoma with normalization of markers who fail to achieve CR who do not undergo second-look surgery undergo 3DRT or IMRT QD 5 days a week for 24 days
Patients with non-normalized tumor markers or PD and no second-look surgery or viable tumor during second-look surgery discontinue protocol therapy
All patients undergo magnetic resonance imaging MRI and optional blood and tissue sample collection throughout the study Patients may undergo lumbar puncture LP for CSF sample collection during screening and follow up
After completion of study treatment patients are followed up every 3 months for 12 months every 4 months for 24 months and then annually for up to 120 months
I To determine whether 12 Gy whole ventricular irradiation WVI and 12 Gy tumor boost would maintain similar efficacy compared to ACNS1123 stratum 2 as measured by event-free survival EFS in eligible patients with localized primary central nervous system CNS germinoma who present with serum andor cerebrospinal fluid CSF human chorionic gonadotropin-beta hCGbeta 100 IUL and normal alpha-fetoprotein AFP and meet complete response CR or continued complete response CCR criteria following chemotherapysecond-look surgery Stratum 1
SECONDARY OBJECTIVES
I To estimate the EFS distribution for patients with localized midline - including bifocal - CNS germinoma with partial response PR after chemotherapy followed by 18 Gy WVI and 12 Gy tumor boost Stratum 2
II To estimate the EFS distribution for patients with localized midline - including bifocal - CNS germinoma with less than a PR after chemotherapy followed by 24 Gy WVI and 12 Gy tumor boost Stratum 3
III To estimate the overall survival OS response rates to chemotherapy and radiotherapy RT as well as the patterns of failure of the various cohorts based on tumor characteristics treatment regimen and treatment modality
IV To determine the impact of tumor characteristics treatment regimen and treatment modalities on the long-term neuroendocrine function for patients with CNS germinomas
V To prospectively evaluate processing speed of children and young adults with CNS germinoma through the Childrens Oncology Group COG Standardized assessment battery
EXPLORATORY OBJECTIVES
I To estimate the EFS distribution for patients with metastatic germinomas treated with chemotherapy followed by craniospinal irradiation CSI 18 Gy for CRCCR Stratum 4 or 24 Gy for less than CR Stratum 5 with a 12 Gy tumor boost to the pre-treatment volume including metastatic sites
II To estimate the EFS distribution for patients with basal ganglia and thalamic germinomas BGTG treated with chemotherapy followed by whole brain irradiation WBI 18 Gy for CRCCR Stratum 6 or 24 Gy for less than CR Stratum 7 with a 12 Gy tumor boost to the pre-treatment volume
III To prospectively collect blood cerebrospinal fluid and tumor tissue at diagnosis and second-look surgery if feasible for future biology studies
IV To prospectively measure the incidence of cerebral vascular events stroke or transient ischemic attacks in the follow-up period and longitudinally evaluate and model the cognitive social and behavioral functioning of children and young adults with CNS germinoma through the COG Standardized assessment battery and compare these outcomes based on tumor characteristics treatment regimen and treatment modality
OUTLINE
INDUCTION PHASE All patients receive carboplatin intravenously IV over 15-60 minutes on day 1 and etoposide IV over 90-120 minutes on days 1-3 of each cycle Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity
Patients are then assigned to 1 of 7 strata
STRATUM I Patients with localized germinoma achieving CR with normalization of markers undergo 3-dimensional conformal radiation therapy 3DCRT or intensity-modulated radiation therapy IMRT once daily QD 5 days a week for 16 days Patients achieving PR with normalization of markers may undergo second-look surgery Patients found to have mature teratoma or non-viable tumor undergo 3DRT or IMRT QD 5 days a week for 16 days Patients with normalization of markers who fail to achieve CR or PR may undergo second-look surgery Patients found to have mature teratoma or non-viable tumor undergo 3DRT or IMRT QD 5 days a week for 16 days Patients with bifocal germinoma undergo 3DRT or IMRT QD 5 days a week for 16 days
STRATUM II Patients with localized germinoma achieving PR with normalization of markers who do not undergo second-look surgery undergo 3DRT or IMRT QD 5 days a week for 20 days
STRATUM III Patients with localized germinoma with normalization of markers who fail to achieve CR or PR who do not undergo second-look surgery undergo 3DRT or IMRT QD 5 days a week for 24 days
STRATUM IV Patients with metastatic germinoma achieving CR undergo 3DRT or IMRT QD 5 days a week for 20 days Patients with metastatic germinoma and normalization of markers who fail to achieve CR may undergo second-look surgery Patients found to have mature teratoma or non-viable tumor undergo 3DRT or IMRT QD 5 days a week for 20 days
STRATUM V Patients with metastatic germinoma with normalization of markers who fail to achieve CR who do not undergo second-look surgery undergo 3DRT or IMRT QD 5 days a week for 24 days
STRATUM VI Patients with basal ganglia and thalamic germinoma achieving CR undergo 3DRT or IMRT QD 5 days a week for 20 days Patients with basal ganglia and thalamic germinoma and normalization of markers who fail to achieve CR may undergo second-look surgery Patients found to have mature teratoma or non-viable tumor undergo 3DRT or IMRT QD 5 days a week for 20 days
STRATUM VII Patients with basal ganglia and thalamic germinoma with normalization of markers who fail to achieve CR who do not undergo second-look surgery undergo 3DRT or IMRT QD 5 days a week for 24 days
Patients with non-normalized tumor markers or PD and no second-look surgery or viable tumor during second-look surgery discontinue protocol therapy
All patients undergo magnetic resonance imaging MRI and optional blood and tissue sample collection throughout the study Patients may undergo lumbar puncture LP for CSF sample collection during screening and follow up
After completion of study treatment patients are followed up every 3 months for 12 months every 4 months for 24 months and then annually for up to 120 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2024-03518 | REGISTRY | None | None |
| ACNS2321 | OTHER | None | None |
| ACNS2321 | OTHER | None | None |
| U10CA180886 | NIH | CTEP | httpsreporternihgovquickSearchU10CA180886 |