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NCT Number: NCT05776342

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

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.

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Key information

Conditions

Pancreatic Adenocarcinoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Jean Minjoz, Besançon, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Overall Survival (OS) rate

    Time frame: 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 outcomes

  1. Progression-free survival (PFS) rate

    Time frame: 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

  2. Number of patient with objective response rate

    Time frame: 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.

  3. Number of patient with stability rate

    Time frame: 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.

  4. Number of patient with tumor progression

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: Up to 7 years

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

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

    Time frame: Up to 7 years

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

Study contacts

Contact information is provided by the study sponsor or research team.

Angelique VIENOT, MD

CONTACT

[email protected]

01402985 00

Sponsors and collaborators

Lead sponsor

GERCOR - Multidisciplinary Oncology Cooperative Group

Other

Registry information

Official study title

Prognostic and Predictive Markers of Treatment Response in Patients With Pancreatic Adenocarcinoma

Acronym: CANOPE

Important dates

Study start
2003
Primary completion
2030
Study completion
2031
First posted
Mar 20, 2023
Registry last updated
Mar 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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