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RecruitingNCT05776342CANOPEUpdated Mar 25, 2025

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

An observational study in Pancreatic Adenocarcinoma, sponsored by GERCOR - Multidisciplinary Oncology Cooperative Group. Recruiting at 15 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-03-25.

Sponsored by GERCOR - Multidisciplinary Oncology Cooperative Group · Observational

From the registry’s dates

  • Started Jan 2003; still recruiting 23 years 9 months later.
Study type
Observational
Model
Cohort
Time perspective
Other
Enrollment
4,050
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Pancreatic Adenocarcinoma

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03

In context

Adenocarcinoma

2,004 studies on the registry are indexed under Adenocarcinoma; 375 are open to participants now.

This study's planned enrollment of 4,050 is above the median of 153 across 332 observational studies indexed under Adenocarcinoma.

Browse Adenocarcinoma studies →

Lead sponsor

GERCOR - Multidisciplinary Oncology Cooperative Group is the lead sponsor of 76 studies on the registry; 12 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Retro-prospective (diagnosis between 2003 and 2022) and prospective (diagnosis between 2023 and 2030) cohorts of patients with pancreatic adenocarcinoma

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

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
05

Study design

Observational model
Cohort
Time perspective
Other
Enrollment
4,050 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Overall Survival (OS) rate

    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

    Time frame: Up to 7 years from the date of initial cancer diagnosis (or until death if it occurs before 17 years)

Secondary outcomes

  1. Progression-free survival (PFS) rate

    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

    Time frame: Up to 7 years

  2. Number of patient with objective response rate

    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.

    Time frame: Up to 7 years

  3. Number of patient with stability rate

    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.

    Time frame: Up to 7 years

  4. Number of patient with tumor progression

    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.

    Time frame: Up to 7 years

  5. Number of patient with grade 3/4 treatment-related toxicities

    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.

    Time frame: Up to 7 years

  6. Number of patients who received maintenance treatment in the first-line

    Study the profiles of patients receiving maintenance treatment in 1st-line chemotherapy

    Time frame: Up to 7 years

  7. Number of patients who received second and third-line treatments

    Study the profiles of patients receiving 2nd and 3rd lines of chemotherapy

    Time frame: Up to 7 years

07

Study locations

7 of 15 sites recruiting
  • CHU Jean Minjoz
    Besançon, France
    • Angélique VIENOT, MD · Contact
    • Angélique VIENOT, MD · Principal investigator
    Recruiting
  • Hôpital Beaujon
    Clichy, France
    • Louis DE MESTIER, MD · Contact
    Recruiting
  • CHU - Henri Mondor
    Créteil, France
    • Christophe TOURNIGAND, MD · Contact
    Not yet recruiting
  • CHU Lille
    Lille, France
    • Anthony TURPIN, MD · Contact
    Recruiting
  • Centre Léon Bérard
    Lyon, France
    • Pauline ROCHEFORT, MD · Contact
    Not yet recruiting
  • HRU Nancy Site Brabois
    Nancy, France
    • Marie MULLER, MD · Contact
    Recruiting
  • Hôpital Georges Pompidou
    Paris, France
    • Jeanne NETTER, MD · Contact
    Recruiting
  • Hôpital Saint Antoine
    Paris, France
    • Antoine DARDENNE · Contact
    Recruiting
  • Institut Mutualiste Montsouris
    Paris, France
    • David MALKA, MD · Contact
    Not yet recruiting
  • CHU Poitiers
    Poitiers, France
    • David TOUGERON, MD · Contact
    • David TOUGERON, MD · Principal investigator
    Not yet recruiting
  • CHU Reims
    Reims, France
    • Olivier BOUCHE, MD · Contact
    Not yet recruiting
  • CHU Pontchaillou
    Rennes, France
    • Astrid LIEVRE, MD · Contact
    • Astrid LIEVRE, MD · Principal investigator
    Not yet recruiting
  • Institut Curie
    Saint-Cloud, France
    • Cindy NEUZILLET, MD · Contact
    Not yet recruiting
  • IHU - Institut de chirurgie guidée par l'imagerie
    Strasbourg, France
    • Julieta MONTANELLI, MD · Contact
    Not yet recruiting
  • Hôpital Paul Brousse
    Villejuif, France
    • Pascal HAMMEL, MD · Contact
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 25, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05776342
Lead sponsor
GERCOR - Multidisciplinary Oncology Cooperative Group
Responsible party
Sponsor
First posted
Mar 20, 2023
Start date
Jan 1, 2003
Primary completion
Dec 31, 2030 (estimated)
Completion
Dec 31, 2031 (estimated)
Last update
Mar 25, 2025

Study contacts

Angelique VIENOT, MD
Contact
regulatory.Affairs@gercor.com.fr
01402985 00
Angelique VIENOT, MD
principal investigator · CHRU de Besançon - Institut Régional Fédératif du Cancer (IRFC) de Franche-Comté
Anthony Turpin, MD
principal investigator · Hôpital Claude-Huriez

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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