Ignite Creation Date:
2024-05-06 @ 8:25 AM
Last Modification Date:
2024-10-26 @ 12:00 PM
Study NCT ID:
NCT02735850
Status:
WITHDRAWN
Last Update Posted:
2017-05-23
First Post:
2016-03-22
Brief Title:
Combination of SABR and L19-IL2 in Patients With Stage IV Lung Cancer ImmunoSABR
Sponsor:
Maastricht Radiation Oncology
Organization:
Maastricht Radiation Oncology
Study Overview
Official Title:
A Randomized Phase II Trial of the Combination of SBRT With L19-IL2 in Patients With Limited Metastatic Non-small Cell Lung Cancer NSCLC
Status:
WITHDRAWN
Status Verified Date:
2016-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not yet submitted unclear timelines
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ImmunoSABR
Brief Summary:
This will be a phase II trial testing if the combination of SBRT and L19-IL2 improves the progression free survival in patients with limited metastatic non-small cell lung cancer NSCLC Treatment will be divided in two cohorts patients eligible for ablative stereotactic body radiotherapy to all metastatic sites treatment with curative intent and patients not eligible for stereotactic body radiotherapy to all sites life prolongation
Detailed Description:
IMMUNOSABR will include 138 patients The trialpopulation will be divided in two cohorts patients eligible for ablative stereotactic body radiotherapy to all metastatic sites treatment with curative intent and patients not eligible for stereotactic body radiotherapy to all sites life prolongationIn this single stage phase II trial we aim to demonstrate absolute increase in progression free survival at two years PFS will be determined as the time between randomization and disease progression according to RECIST 11 death due to any cause or last patient contact alive and progression-free Patients will be randomized between control no L19-IL2 and experimental arms with L19-IL2 in a 11 ratio The accrual period will be 29 months or 241 years and the minimum follow-up will be 24 months or 2 years making the total study duration 53 months or 441 years Comparison between control and experimental arms will be done using the Log-Rank statistic This test for superiority will be one-sided with a desired type I error of 010 and power of 080 The randomization allocation is 11
Primary endpoint and power calculation For the ablative cohort the expected 2-year PFS is 20 in the control arm arm A and 40 in the experimental arm arm B The study is therefore powered to test for a difference in PFS at 2 years of 20 The null hypothesis H0 is that there is no difference in PFS between arm A and arm B This results in a sample size of 72 patients evenly divided over two arms with 36 patient per arm Considering a dropout rate of 10 from current experience the actual amount of patients will be 40 per arm or 80 in total
For the non-ablative cohort the expected 2-year PFS is 10 in the control arm arm C and 30 in the experimental arm arm D The study is therefore powered to test for a difference in PFS at 2 years of 20 The null hypothesis H0 is that there is no difference in PFS between arm C and arm D This resuls in a sample size of 52 patients evenly divided over two arms with 26 patient per arm Considering a dropout rate of 10 from current experience the actual amount of patients will be 29 per arm or 58 in total
The total number of patients needed for the trial is the sum of the amount of patients in the ablative cohort 80 patients and the amount of patients in the non-ablative cohort 58 patients 138 patients
Secondary endpoints Simple univariate comparisons of outcome and toxicity will be made between both treatment arms in each cohort using Chi-square tests for categorical data and independent samples t-tests for scale data Secondary study parameters Overall survival OS will be assessed using survival tables and Kaplan-Meier curves OS will be calculated from the day of randomisation Abscopal response which can only be measured in the non-ablative cohort with at least one non-irradiated target lesion will measured as best response between experimental and standard treatment arms Quality of life EORTC QLQ-C30 version 30 and QLQ-LC13 questionnaires will be recorded at regular intervals Average changes in quality of life will be reported in terms of absolute differences in scores and also in terms of minimally clinically relevant changes
Primary endpoint and power calculation For the ablative cohort the expected 2-year PFS is 20 in the control arm arm A and 40 in the experimental arm arm B The study is therefore powered to test for a difference in PFS at 2 years of 20 The null hypothesis H0 is that there is no difference in PFS between arm A and arm B This results in a sample size of 72 patients evenly divided over two arms with 36 patient per arm Considering a dropout rate of 10 from current experience the actual amount of patients will be 40 per arm or 80 in total
For the non-ablative cohort the expected 2-year PFS is 10 in the control arm arm C and 30 in the experimental arm arm D The study is therefore powered to test for a difference in PFS at 2 years of 20 The null hypothesis H0 is that there is no difference in PFS between arm C and arm D This resuls in a sample size of 52 patients evenly divided over two arms with 26 patient per arm Considering a dropout rate of 10 from current experience the actual amount of patients will be 29 per arm or 58 in total
The total number of patients needed for the trial is the sum of the amount of patients in the ablative cohort 80 patients and the amount of patients in the non-ablative cohort 58 patients 138 patients
Secondary endpoints Simple univariate comparisons of outcome and toxicity will be made between both treatment arms in each cohort using Chi-square tests for categorical data and independent samples t-tests for scale data Secondary study parameters Overall survival OS will be assessed using survival tables and Kaplan-Meier curves OS will be calculated from the day of randomisation Abscopal response which can only be measured in the non-ablative cohort with at least one non-irradiated target lesion will measured as best response between experimental and standard treatment arms Quality of life EORTC QLQ-C30 version 30 and QLQ-LC13 questionnaires will be recorded at regular intervals Average changes in quality of life will be reported in terms of absolute differences in scores and also in terms of minimally clinically relevant changes
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