Efficacy of First-Line Gemcitabine Chemotherapy in GemCore+ Metastatic Pancreatic Adenocarcinoma Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Analyze of GemCore status.
- Who it may be relevant to
- Registry conditions: Cancer Of Pancreas. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Phase IV Study Assessing Efficacy of First-Line Chemotherapy With Gemcitabine in GemCore+ Metastatic Pancreatic Adenocarcinoma Patients Ineligible to FOLFIRINOX Treatment
Overview
The goal of this interventional study is to learn about the efficacy of first-line chemotherapy with Gemcitabine in metastatic pancreatic adenocarcinoma patients expressing the GemCore signature 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 GemCore signature. 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 GemCore signature. The center will manage the participant's follow up as usually realized in standard care.
Interventions
- Other Analyze of GemCore status
Genomic analyze of GemCore status
Primary outcome measures
- Percentage of alive GemCore+ patients treated with Gemcitabine [Time frame: 12 months]
Secondary outcome measures (3)
- Overall survival [Time frame: 24 months]
- Tumor response rate [Time frame: 24 months]
- Progression-free survival [Time frame: 24 months]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
France · 1 center
- Institut Paoli Calmettes — Marseille
Identifiers
NCT: NCT06046794 · GemSign-01-IPC 2022-068