Prognostic and Predictive Markers of Treatment Response in Patients With PAC.

Recruiting

• Conditions: Pancreatic Adenocarcinoma

• Registration Number: NCT05776342
• Lead Sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group

Brief Summary

The objective of this study is to identify prognosis and predictive markers of response to treatments (surgery, chemotherapy,...) in patients with pancreatic adenocarcinoma. The effectiveness and tolerance of these treatments in current practice is also evaluated.

Detailed Description

The modest efficacy of current therapies for pancreatic cancer calls for the development of prognostic factors to guide patient selection and clinical decision-making based on tumor aggressiveness and risk of death.

The aim of this study is to identify prognostic and predictive factors of response to treatments administered in pancreatic adenocarcinoma, based on a multicenter cohort established on a population derived from current clinical practice. By accurately stratifying patients according to their estimated survival, prognostic tools could aid therapeutic decisions and optimize patient selection in future clinical trials.

Study Timeline

• Study Start: 2003-01-01
• Study First Submitted: 2023-03-08
• Study First Submitted QC: 2023-03-08
• Study First Posted: 2023-03-20
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-21
• Last Update Posted: 2025-03-25
• Primary Completion: 2030-12-31
• Study Completion: 2031-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 4050

Inclusion Criteria

• Patient with histologically confirmed pancreatic adenocarcinoma.
• Disease at a resectable, borderline, locally advanced, initially metastatic, or recurrent stage after surgery
• Diagnosis between January 1, 2003, and December 31, 2030.
• First-line treatment with chemotherapy and/or radiotherapy and/or clinical trials.
• Age ≥ 18 years.
• Written informed consent

Exclusion Criteria

• Patient under guardianship, curatorship, or judicial protection.
• Pregnant or breastfeeding women.
• Any medical, psychological, or social situation that could prevent compliance with the protocol as assessed by the investigator.
• Refusal to participate in the study

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall Survival (OS) rate	Up to 7 years from the date of initial cancer diagnosis (or until death if it occurs before 17 years)	Defined as the time interval between the start date of treatment (surgery, first cycle of L1 chemotherapy, or first radiotherapy session) and the date of death regardless of the cause. Living or lost to follow-up patients will be censored at the date of the last news

Secondary Outcome Measures

Name	Time	Method
Number of patients who received second and third-line treatments	Up to 7 years	Study the profiles of patients receiving 2nd and 3rd lines of chemotherapy
Progression-free survival (PFS) rate	Up to 7 years	Defined as the time interval between the start date of treatment (surgery, first cycle of L1 chemotherapy, or first radiotherapy session) and the date of first progression or date of death regardless of the cause. Living patients without progression or lost to follow-up will be censored at the date of the last news
Number of patient with stability rate	Up to 7 years	Evaluation according to RECIST v1.1, Choi or iRECIST criteria. Study the population followed for pancreatic adenocarcinoma according to tumor stages (localized, borderline, locally advanced, metastatic or recurrent after surgery) and according to treatments.
Number of patient with grade 3/4 treatment-related toxicities	Up to 7 years	Toxicity rates according to CTCAE v5.0 classification. Study the population followed for pancreatic adenocarcinoma according to tumor stages (localized, borderline, locally advanced, metastatic or recurrent after surgery) and according to treatments.
Number of patients who received maintenance treatment in the first-line	Up to 7 years	Study the profiles of patients receiving maintenance treatment in 1st-line chemotherapy
Number of patient with objective response rate	Up to 7 years	Evaluation according to RECIST v1.1, Choi or iRECIST criteria. Study the population followed for pancreatic adenocarcinoma according to tumor stages (localized, borderline, locally advanced, metastatic or recurrent after surgery) and according to treatments.
Number of patient with tumor progression	Up to 7 years	Evaluation according to RECIST v1.1, Choi or iRECIST criteria. Study the population followed for pancreatic adenocarcinoma according to tumor stages (localized, borderline, locally advanced, metastatic or recurrent after surgery) and according to treatments.

Trial Locations

Locations (15)

CHU Jean Minjoz; 🇫🇷 Besançon, France

HRU Nancy Site Brabois; 🇫🇷 Nancy, France

CHU Reims; 🇫🇷 Reims, France

Institut Curie; 🇫🇷 Saint-Cloud, France

Hôpital Georges Pompidou; 🇫🇷 Paris, France

Hôpital Saint Antoine; 🇫🇷 Paris, France

CHU Poitiers; 🇫🇷 Poitiers, France

Hôpital Paul Brousse; 🇫🇷 Villejuif, France

IHU - Institut de chirurgie guidée par l'imagerie; 🇫🇷 Strasbourg, France

CHU - Henri Mondor; 🇫🇷 Créteil, France

Centre Léon Bérard; 🇫🇷 Lyon, France

Hôpital Beaujon; 🇫🇷 Clichy, France

Institut Mutualiste Montsouris; 🇫🇷 Paris, France

CHU Lille; 🇫🇷 Lille, France

CHU Pontchaillou; 🇫🇷 Rennes, France