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Efficacy of First-Line Gemcitabine Chemotherapy in GemCore+ Metastatic Pancreatic Adenocarcinoma Patients (GemSign-01)

Primary Purpose

Cancer Of Pancreas

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Analyze of GemCore status
Sponsored by
Institut Paoli-Calmettes
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Cancer Of Pancreas

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Metastatic pancreatic adenocarcinoma histological proved FOLFIRINOX chemotherapy-ineligible patient and going to receive first-line metastatic chemotherapy with gemcitabine monotherapy Tumor material allowing assessment of GEMCore status (i.e. FFPE block with tumor cellularity ≥ 10%); Life expectancy > 2 months; Measurable target according to RECIST 1.1 criteria; No previous treatment in metastatic situation; Age ≥ 18 years; Patient not opposed to study participation; Affiliation to a social security system, or beneficiary of such a scheme. Exclusion Criteria: Contraindication to Gemcitabine treatment; ECOG performance status ≥ 3; Person in emergency situation or unable to express non-opposition; Patient under a legal protection measure (adult under guardianship, curatorship or safeguard of justice); Unable to undergo medical follow-up for geographical, social or psychological reasons.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    metastatic pancreatic adenocarcinoma patients

    Arm Description

    Analyze of GemCore status

    Outcomes

    Primary Outcome Measures

    Percentage of alive GemCore+ patients treated with Gemcitabine
    Percentage of alive GemCore+ patients treated with Gemcitabine

    Secondary Outcome Measures

    Overall survival
    Overall survival
    Tumor response rate
    Tumor response rate
    Progression-free survival
    Progression-free survival

    Full Information

    First Posted
    September 6, 2023
    Last Updated
    September 19, 2023
    Sponsor
    Institut Paoli-Calmettes
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06046794
    Brief Title
    Efficacy of First-Line Gemcitabine Chemotherapy in GemCore+ Metastatic Pancreatic Adenocarcinoma Patients
    Acronym
    GemSign-01
    Official Title
    Phase IV Study Assessing Efficacy of First-Line Chemotherapy With Gemcitabine in GemCore+ Metastatic Pancreatic Adenocarcinoma Patients Ineligible to FOLFIRINOX Treatment
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    November 1, 2023 (Anticipated)
    Primary Completion Date
    November 1, 2027 (Anticipated)
    Study Completion Date
    November 1, 2027 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Institut Paoli-Calmettes

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The goal of this interventional study is to learn about the efficacy of first-line chemotherapy with Gemcitabine in metastatic pancreatic adenocarcinoma patients having a modification of the GemCore gene in their tumor. The main question it aims to answer is to assess efficacy of Gemcitabine (tumor response, survival rate) in the population of patient bearing the modification of GemCore gene. Participants will start the chemotherapy with Gemcitabine as usually performed in standard care of their center. They will consent to a genomic analyze of their tumor to know if it bears the modification of the GemCore gene. The center will manage the participant's follow up as usually realized in standard care.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cancer Of Pancreas

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    metastatic pancreatic adenocarcinoma patients
    Arm Type
    Experimental
    Arm Description
    Analyze of GemCore status
    Intervention Type
    Other
    Intervention Name(s)
    Analyze of GemCore status
    Intervention Description
    Genomic analyze of GemCore status
    Primary Outcome Measure Information:
    Title
    Percentage of alive GemCore+ patients treated with Gemcitabine
    Description
    Percentage of alive GemCore+ patients treated with Gemcitabine
    Time Frame
    12 months
    Secondary Outcome Measure Information:
    Title
    Overall survival
    Description
    Overall survival
    Time Frame
    24 months
    Title
    Tumor response rate
    Description
    Tumor response rate
    Time Frame
    24 months
    Title
    Progression-free survival
    Description
    Progression-free survival
    Time Frame
    24 months
    Other Pre-specified Outcome Measures:
    Title
    Overall survival of GemCore- patients
    Description
    Overall survival of GemCore- patients
    Time Frame
    24 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Metastatic pancreatic adenocarcinoma histological proved FOLFIRINOX chemotherapy-ineligible patient and going to receive first-line metastatic chemotherapy with gemcitabine monotherapy Tumor material allowing assessment of GEMCore status (i.e. FFPE block with tumor cellularity ≥ 10%); Life expectancy > 2 months; Measurable target according to RECIST 1.1 criteria; No previous treatment in metastatic situation; Age ≥ 18 years; Patient not opposed to study participation; Affiliation to a social security system, or beneficiary of such a scheme. Exclusion Criteria: Contraindication to Gemcitabine treatment; ECOG performance status ≥ 3; Person in emergency situation or unable to express non-opposition; Patient under a legal protection measure (adult under guardianship, curatorship or safeguard of justice); Unable to undergo medical follow-up for geographical, social or psychological reasons.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Dominique GENRE, Dr
    Phone
    0491223778
    Email
    drci.up@ipc.unicancer.fr

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Efficacy of First-Line Gemcitabine Chemotherapy in GemCore+ Metastatic Pancreatic Adenocarcinoma Patients

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