Ignite Creation Date:
2024-05-06 @ 5:55 PM
Last Modification Date:
2024-10-26 @ 2:38 PM
Study NCT ID:
NCT05475366
Status:
RECRUITING
Last Update Posted:
2024-01-30
First Post:
2022-07-07
Brief Title:
Personalized First-line Chemotherapy Choice in Advanced Pancreatic Adenocarcinoma Using Transcriptomic Signatures
Sponsor:
Institut Curie
Organization:
Institut Curie
Study Overview
Official Title:
Pilot Study of Personalized First-line Chemotherapy Choice for Patients With Advanced Pancreatic Adenocarcinoma Using Transcriptomic Signatures PACsign
Status:
RECRUITING
Status Verified Date:
2024-01
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:
PACsign
Brief Summary:
The aim of this study is to assess the clinical value of 5 transcriptomic signatures prognostic of chemotherapeutic sensitivity to improve the Objective Response Rate ORR of first-line L1 Chemotherapy regimen FOLFIRINOX vs Gem-nabP will be selected based on transcriptomic signatures applied to the pre-therapeutic liver biopsy of newly diagnosed PDAC patients
Detailed Description:
Step 1 patients will sign a 1st informed consent prospectively for the molecular screening RNAseq profile 5 transcriptomic signatures will be applied for prediction of response to 5 Fluoro-Uracil 5FU oxaliplatin irinotecan gemcitabine and taxane Biomarker status will be obtained for all patients as part of good clinical practice
Patients will be eligible for prospective step 2 only if the transcriptomic analysis is informative and the treatment can be started within 28 days
Step 2 study treatment strategy based on the results of transcriptomic signatures patients will receive either FOLFIRINOX or Gem-nabP according to the following algorithm 2nd informed consent
Predicted to be FOLFIRINOX sensitive regardless of sensitivity to Gem-nabP FOLFIRINOX
Predicted to be FOLFIRINOX and Gem-nabP resistant FOLFIRINOX
Presence of a germline breast cancer BRCA mutation regardless of transcriptomic signature FOLFIRINOX tumors sensitive to platinum
Predicted to be Gem-nabP sensitive and FOLFIRINOX resistant Gem-nabP
Chemotherapy with FOLFIRINOX and Gemcitabine plus nab-paclitaxel will be administered as in routine practice according to their approval Dose adaptation will be allowed according to investigators usual practice
Patients will be eligible for prospective step 2 only if the transcriptomic analysis is informative and the treatment can be started within 28 days
Step 2 study treatment strategy based on the results of transcriptomic signatures patients will receive either FOLFIRINOX or Gem-nabP according to the following algorithm 2nd informed consent
Predicted to be FOLFIRINOX sensitive regardless of sensitivity to Gem-nabP FOLFIRINOX
Predicted to be FOLFIRINOX and Gem-nabP resistant FOLFIRINOX
Presence of a germline breast cancer BRCA mutation regardless of transcriptomic signature FOLFIRINOX tumors sensitive to platinum
Predicted to be Gem-nabP sensitive and FOLFIRINOX resistant Gem-nabP
Chemotherapy with FOLFIRINOX and Gemcitabine plus nab-paclitaxel will be administered as in routine practice according to their approval Dose adaptation will be allowed according to investigators usual practice
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