Ignite Creation Date:
2024-05-06 @ 2:32 AM
Last Modification Date:
2024-10-26 @ 11:20 AM
Study NCT ID:
NCT02066220
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2022-04-19
First Post:
2014-02-07
Brief Title:
International Society of Paediatric Oncology SIOP PNET 5 Medulloblastoma
Sponsor:
Universitätsklinikum Hamburg-Eppendorf
Organization:
Universitätsklinikum Hamburg-Eppendorf
Study Overview
Official Title:
AN INTERNATIONAL PROSPECTIVE TRIAL ON MEDULLOBLASTOMA MB IN CHILDREN OLDER THAN 3 TO 5 YEARS WITH WNT BIOLOGICAL PROFILE PNET 5 MB - LR and PNET 5 MB - WNT-HR AVERAGE-RISK BIOLOGICAL PROFILE PNET 5 MB -SR OR TP53 MUTATION AND REGISTRY FOR MB OCCURRING IN THE CONTEXT OF GENETIC PREDISPOSITION
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2022-04
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:
The study PNET 5 MB has been designed for children with medulloblastoma of standard risk according to the risk-group definitions which have been used so far eg in PNET 4 With the advent of biological parameters for stratification into clinical medulloblastoma trials the ß-catenin status will be the only criterion according to which study patients will be assigned to either treatment arm PNET 5 MB - LR or to PNET 5 MB - SR respectively The initial diagnostic assessments imaging staging histology and tumor biology required for study entry are the same for both treatment arms With the amendment for version 12 of the protocol patients who have a WNT-activated medulloblastoma with clinically high-risk features can be included in the PNET 5 MB WNT-HR study and patients with a high-risk SHH medulloblastoma with TP53 mutation both somatic or germline including mosaicism can be included in the PNET5 MB SHH-TP53 study
Data on patients with pathogenic germline alteration or cancer predisposition syndrome who cannot be included in any prospective trial due to unavailability or due to physician or family decision can be documented within the observational PNET 5 MB registry
Data on patients with pathogenic germline alteration or cancer predisposition syndrome who cannot be included in any prospective trial due to unavailability or due to physician or family decision can be documented within the observational PNET 5 MB registry
Detailed Description:
The aim of the LR-study is to confirm the high rate of event-free survival in patients between the ages of 3 to 5 years and less than 22 with standard risk medulloblastoma with a low-risk biological profile Patients eligible for the study will be those with non-metastatic medulloblastoma by CSF cytology and centrally reviewed MRI imaging at diagnosis and low-risk biological profile defined as ß-catenin nuclear immuno-positivity by immuno-histochemistry IHC Patients will have undergone total or near-total tumour resection and will receive conventionally fractionated once a day radiotherapy with a dose of 54 Gy to the primary tumor and 180 Gy to the craniospinal axis Following radiotherapy patients will receive a reduced-intensity chemotherapy with a total of 6 cycles of chemotherapy consisting of 3 courses of cisplatin CCNU and vincristine alternating with 3 courses of cyclophosphamide and vincristine
The aim of the SR-study is to test whether concurrent carboplatin during radiotherapy followed by 8 cycles of maintenance chemotherapy in patients with standard risk medulloblastoma with an average-risk biological profile may improve outcome Patients eligible for the study will be those with non-metastatic medulloblastoma by CSF cytology and centrally reviewed MRI imaging at diagnosis and average-risk biological profile defined as ß-catenin nuclear immuno-negativity by IHC Patients will have undergone total or near-total tumour resection and will receive conventionally fractionated once a day radiotherapy with a dose of 54 Gy to the primary tumor and 234 Gy to the craniospinal axis Following radiotherapy patients will receive a modified-intensity chemotherapy with a total of 8 cycles of chemotherapy consisting of 4 courses of cisplatin CCNU and vincristine alternating with 4 courses of cyclophosphamide and vincristine
The primary aim of the WNT-HR study is to maintain a 3-year EFS over 80 The small number of patients does not allow neither conventional methods of test size and power nor strict stopping rules The 3-year EFS will be estimated by the Kaplan-Meier method at the end of the trial and its two-sided 95 confidence interval will be calculated
The primary endpoint of the SHH-TP53 study is event-free survival EFS The aim of the study is the comparison of EFS between patients receiving a dose reduced induction chemotherapy radiotherapy and maintenance chemotherapy and a historic population from unpublished data
The aim of the SR-study is to test whether concurrent carboplatin during radiotherapy followed by 8 cycles of maintenance chemotherapy in patients with standard risk medulloblastoma with an average-risk biological profile may improve outcome Patients eligible for the study will be those with non-metastatic medulloblastoma by CSF cytology and centrally reviewed MRI imaging at diagnosis and average-risk biological profile defined as ß-catenin nuclear immuno-negativity by IHC Patients will have undergone total or near-total tumour resection and will receive conventionally fractionated once a day radiotherapy with a dose of 54 Gy to the primary tumor and 234 Gy to the craniospinal axis Following radiotherapy patients will receive a modified-intensity chemotherapy with a total of 8 cycles of chemotherapy consisting of 4 courses of cisplatin CCNU and vincristine alternating with 4 courses of cyclophosphamide and vincristine
The primary aim of the WNT-HR study is to maintain a 3-year EFS over 80 The small number of patients does not allow neither conventional methods of test size and power nor strict stopping rules The 3-year EFS will be estimated by the Kaplan-Meier method at the end of the trial and its two-sided 95 confidence interval will be calculated
The primary endpoint of the SHH-TP53 study is event-free survival EFS The aim of the study is the comparison of EFS between patients receiving a dose reduced induction chemotherapy radiotherapy and maintenance chemotherapy and a historic population from unpublished data
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 |
|---|---|---|---|
| 2011-004868-30 | EUDRACT_NUMBER | None | None |