Ignite Creation Date:
2024-05-06 @ 1:21 AM
Last Modification Date:
2024-10-26 @ 11:02 AM
Study NCT ID:
NCT01784549
Status:
UNKNOWN
Last Update Posted:
2014-11-25
First Post:
2013-02-02
Brief Title:
Customized Neoadjuvant Versus Standard Chemotherapy in NSCL Patients With Resectable Stage IIIA N2Disease
Sponsor:
IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro Genoa Italy
Organization:
IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro Genoa Italy
Study Overview
Official Title:
A Multi-center Phase II Randomized Study of Customized Neoadjuvant Therapy Versus Standard Chemotherapy in Non-small Cell Lung Cancer NSLC Patients With Resectable Stage IIIA N2 Disease CONTEST-TRIAL
Status:
UNKNOWN
Status Verified Date:
2014-11
Last Known Status:
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:
CONTEST
Brief Summary:
The investigators hypothesized that NSCL patients receiving therapy based on their baseline tumor markers levels would attain higher response rates than patients in the control arm receiving non customized therapy
patients with stage IIIAN2 NSCLC will be randomized in a 21 ratio to customized therapy based on biomarkers status ERCC1 RRM1 TS and EGFR mutation vs standard chemotherapy
The primary objective of this multicenter trial is to compare pathological complete response of all subjects randomized by treatment arm
Secondary objectives are to compare all randomized subjects by treatment arm for response rate disease-free survival overall survival one two and three year survival and safety profile
The study is expected to demonstrate both the feasibility of this approach and the logistic problems associated with a biomarker-driven therapeutic strategy in NSCLC
patients with stage IIIAN2 NSCLC will be randomized in a 21 ratio to customized therapy based on biomarkers status ERCC1 RRM1 TS and EGFR mutation vs standard chemotherapy
The primary objective of this multicenter trial is to compare pathological complete response of all subjects randomized by treatment arm
Secondary objectives are to compare all randomized subjects by treatment arm for response rate disease-free survival overall survival one two and three year survival and safety profile
The study is expected to demonstrate both the feasibility of this approach and the logistic problems associated with a biomarker-driven therapeutic strategy in NSCLC
Detailed Description:
- Subjects will be stratified by histology and biological markers ERCC1 RRM1 TS EGFR mutation Randomization will be centralized at the coordinating centre site Patients will receive chemotherapy with cisplatin docetaxel or customized therapy for 3 cycles 60 days with gefitinib before surgery
Every 4 months for 3 years and then every 6 months for 2 years following surgery subjects will be assessed by the investigator for adverse events related to study drug documentation of post study therapies received DFS and survival
- Periodic evaluations of the trial data will be conducted by an independent data monitoring committee to ensure subject safety and the validity and scientific merit of the study
Assuming that the study is not stopped at the planned futility analyses or for safety reasons the final analysis will take place after the targeted number of events pathological complete response is reached which is estimated to take place 24 months post study initiation
- The pathological complete response pCRin the two groups will be computed in the ITT populations and compared by means of the chi-square test without continuity correction For exploratory purposes a multivariate logistic regression model will be fitted to the data with the pCR as the response variable and treatment standard experimental and histomolecular subgroup as covariate The heterogeneity of the relative efficacy of the tailored approach in the various subgroups subgroup analysis will be evaluated by including in the model the appropriate set of treatment-by-subgroup interaction terms using the standard likelihood ratio test Time-to-event analyses DFS and OS will use standard Kaplan-Meier estimators with the Log-rank test and semi-parametric PH regression models Safety will be summarized based on adverse events vital signs and laboratory assessments A group sequential design is used to compare the Overall Survival in the two study arms
Every 4 months for 3 years and then every 6 months for 2 years following surgery subjects will be assessed by the investigator for adverse events related to study drug documentation of post study therapies received DFS and survival
- Periodic evaluations of the trial data will be conducted by an independent data monitoring committee to ensure subject safety and the validity and scientific merit of the study
Assuming that the study is not stopped at the planned futility analyses or for safety reasons the final analysis will take place after the targeted number of events pathological complete response is reached which is estimated to take place 24 months post study initiation
- The pathological complete response pCRin the two groups will be computed in the ITT populations and compared by means of the chi-square test without continuity correction For exploratory purposes a multivariate logistic regression model will be fitted to the data with the pCR as the response variable and treatment standard experimental and histomolecular subgroup as covariate The heterogeneity of the relative efficacy of the tailored approach in the various subgroups subgroup analysis will be evaluated by including in the model the appropriate set of treatment-by-subgroup interaction terms using the standard likelihood ratio test Time-to-event analyses DFS and OS will use standard Kaplan-Meier estimators with the Log-rank test and semi-parametric PH regression models Safety will be summarized based on adverse events vital signs and laboratory assessments A group sequential design is used to compare the Overall Survival in the two study arms
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 |
|---|---|---|---|
| 2011-005267-24 | EUDRACT_NUMBER | None | None |