Ignite Creation Date:
2024-05-06 @ 2:07 PM
Last Modification Date:
2024-10-26 @ 1:25 PM
Study NCT ID:
NCT04221035
Status:
RECRUITING
Last Update Posted:
2024-05-16
First Post:
2020-01-06
Brief Title:
High-Risk Neuroblastoma Study 2 of SIOP-Europa-Neuroblastoma SIOPEN
Sponsor:
Gustave Roussy Cancer Campus Grand Paris
Organization:
Gustave Roussy Cancer Campus Grand Paris
Study Overview
Official Title:
High-Risk Neuroblastoma Study 2 of SIOP-Europa-Neuroblastoma SIOPEN
Status:
RECRUITING
Status Verified Date:
2024-05
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:
HR-NBL2
Brief Summary:
This is an international multicenter open-label randomized phase III trial including three sequential randomizations to assess efficacy of induction and consolidation chemotherapies and radiotherapy for patients with high-risk neuroblastoma
Detailed Description:
This is an international multicenter open-label randomized phase III trial including three sequential randomizations to assess efficacy of induction and consolidation chemotherapies and radiotherapy for patients with high-risk neuroblastoma
The first randomization R-I will compare the efficacy of two induction chemotherapies RAPID COJEC and GPOH regimens in a phase III setting The primary endpoint will be the 3-year EFS from date of randomization The R-I randomization will be stratified on age stage MYCN status and countries
The second randomization R-HDC will compare the efficacy of single HDC with Bu-Mel versus tandem HDC with Thiotepa followed by Bu-Mel The primary endpoint is 3-year EFS calculated from the date of the R-HDC randomization The R-HDC randomization will be stratified on the age stage MYCN status induction chemotherapy regimen response to induction phase and countries
The impact of local treatment in this phase III setting will be assessed according to the presence or not of a macroscopic residual disease after surgery and HDC
In case of macroscopic residual disease 216 Gy radiotherapy to the preoperative tumor bed will be randomized R-RTx versus the same treatment plus a sequential boost of additional 144 Gy to the residual tumor The primary endpoint of R-RTx is 3-year EFS from the date of the R-RTx randomization The R-RTx randomization will be stratified on age stage MYCN status induction chemotherapy regimen HDC regimen and countries
In case of no macroscopic residual disease 216 Gy radiotherapy will be delivered to the preoperative tumor bed
The first randomization R-I will compare the efficacy of two induction chemotherapies RAPID COJEC and GPOH regimens in a phase III setting The primary endpoint will be the 3-year EFS from date of randomization The R-I randomization will be stratified on age stage MYCN status and countries
The second randomization R-HDC will compare the efficacy of single HDC with Bu-Mel versus tandem HDC with Thiotepa followed by Bu-Mel The primary endpoint is 3-year EFS calculated from the date of the R-HDC randomization The R-HDC randomization will be stratified on the age stage MYCN status induction chemotherapy regimen response to induction phase and countries
The impact of local treatment in this phase III setting will be assessed according to the presence or not of a macroscopic residual disease after surgery and HDC
In case of macroscopic residual disease 216 Gy radiotherapy to the preoperative tumor bed will be randomized R-RTx versus the same treatment plus a sequential boost of additional 144 Gy to the residual tumor The primary endpoint of R-RTx is 3-year EFS from the date of the R-RTx randomization The R-RTx randomization will be stratified on age stage MYCN status induction chemotherapy regimen HDC regimen and countries
In case of no macroscopic residual disease 216 Gy radiotherapy will be delivered to the preoperative tumor bed
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
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 |
|---|---|---|---|
| 20192894 | OTHER | CSET number | None |