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

Sponsor
Institut Paoli-Calmettes (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06046794
Collaborator
(none)
100
Enrollment
1
Arm
48
Anticipated Duration (Months)

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Analyze of GemCore status
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Phase IV Study Assessing Efficacy of First-Line Chemotherapy With Gemcitabine in GemCore+ Metastatic Pancreatic Adenocarcinoma Patients Ineligible to FOLFIRINOX Treatment
Anticipated Study Start Date :
Nov 1, 2023
Anticipated Primary Completion Date :
Nov 1, 2027
Anticipated Study Completion Date :
Nov 1, 2027

Arms and Interventions

Arm Intervention/Treatment
Experimental: metastatic pancreatic adenocarcinoma patients

Analyze of GemCore status

Other: Analyze of GemCore status
Genomic analyze of GemCore status

Outcome Measures

Primary Outcome Measures

  1. Percentage of alive GemCore+ patients treated with Gemcitabine [12 months]

    Percentage of alive GemCore+ patients treated with Gemcitabine

Secondary Outcome Measures

  1. Overall survival [24 months]

    Overall survival

  2. Tumor response rate [24 months]

    Tumor response rate

  3. Progression-free survival [24 months]

    Progression-free survival

Other Outcome Measures

  1. Overall survival of GemCore- patients [24 months]

    Overall survival of GemCore- patients

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Institut Paoli-Calmettes

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Institut Paoli-Calmettes
ClinicalTrials.gov Identifier:
NCT06046794
Other Study ID Numbers:
  • GemSign-01-IPC 2022-068
First Posted:
Sep 21, 2023
Last Update Posted:
Sep 21, 2023
Last Verified:
Sep 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Adenocarcinoma
Pancreatic Neoplasms

Study Results

No Results Posted as of Sep 21, 2023