Ignite Creation Date:
2024-05-06 @ 2:21 AM
Last Modification Date:
2024-10-26 @ 11:17 AM
Study NCT ID:
NCT02025881
Status:
TERMINATED
Last Update Posted:
2024-05-24
First Post:
2013-12-30
Brief Title:
Study of Sequential High-dose Chemotherapy in Children With High Risk Medulloblastoma
Sponsor:
Gustave Roussy Cancer Campus Grand Paris
Organization:
Gustave Roussy Cancer Campus Grand Paris
Study Overview
Official Title:
Phase I II Study of Sequential High-dose Chemotherapy With Stem Cell Support in Children Younger Than 5 Years of Age With High-risk Medulloblastoma
Status:
TERMINATED
Status Verified Date:
2024-05
Last Known Status:
Active not recruiting
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 MB-5
Brief Summary:
The trial includes i the evaluation of the efficacy of a treatment strategy designed as a phase II trial and ii a dose-finding part
The Phase II trial is an open label non-randomized multicentre trial without control group A Bayesian approach will be used to analyse the EFS assuming a cure model We will use three prior distributions of the EFS 1 an enthusiastic prior distribution 2 a pessimistic prior distribution and 3 a non-informative prior distribution As the patient outcomes in the trial will be recorded the subsequent distribution of the outcome probability under experimental treatment will be computed by applying Bayes theorem which yields an estimated EFS probability with a 95 credibility interval measure of Bayesian precision Two interim analyses are planned to monitor the efficacy data early stopping rules for futility or inefficacy
The final analysis of efficacy will be made on an intention to treat basis including all recruited patients 3 years after recruitment of the last patient
Due to the uncertainty on the dose of cyclophosphamide that can be given in combination with Busilvex for the last chemotherapy course in patients in complete response after intensification chemotherapy treatment a dose-finding subtrial will be performed to address this issue Phase I part The dose escalation of cyclophosphamide will be performed using the Continual Reassessment Method in a Bayesian framework
The Phase II trial is an open label non-randomized multicentre trial without control group A Bayesian approach will be used to analyse the EFS assuming a cure model We will use three prior distributions of the EFS 1 an enthusiastic prior distribution 2 a pessimistic prior distribution and 3 a non-informative prior distribution As the patient outcomes in the trial will be recorded the subsequent distribution of the outcome probability under experimental treatment will be computed by applying Bayes theorem which yields an estimated EFS probability with a 95 credibility interval measure of Bayesian precision Two interim analyses are planned to monitor the efficacy data early stopping rules for futility or inefficacy
The final analysis of efficacy will be made on an intention to treat basis including all recruited patients 3 years after recruitment of the last patient
Due to the uncertainty on the dose of cyclophosphamide that can be given in combination with Busilvex for the last chemotherapy course in patients in complete response after intensification chemotherapy treatment a dose-finding subtrial will be performed to address this issue Phase I part The dose escalation of cyclophosphamide will be performed using the Continual Reassessment Method in a Bayesian framework
Detailed Description:
None
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 |
|---|---|---|---|
| 20121908 | OTHER | CSET number | None |