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

Sponsor
GERCOR - Multidisciplinary Oncology Cooperative Group (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05776342
Collaborator
(none)
4,050
15
100.1
270
2.7

Study Details

Study Description

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 will also be evaluated.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    4050 participants
    Observational Model:
    Cohort
    Time Perspective:
    Other
    Official Title:
    Prognostic and Predictive Markers of Treatment Response in Patients With Pancreatic Adenocarcinoma
    Anticipated Study Start Date :
    Mar 30, 2023
    Anticipated Primary Completion Date :
    Aug 1, 2030
    Anticipated Study Completion Date :
    Aug 1, 2031

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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

    2. Number of patient with Objective response rate [Up to 7 years]

      Evaluation according to RECIST v1.1, Choi or iRECIST criteria

    3. Number of patient with Stability rate [Up to 7 years]

      Evaluation according to RECIST v1.1, Choi or iRECIST criteria

    4. Number of patient with Tumor progression [Up to 7 years]

      Evaluation according to RECIST v1.1, Choi or iRECIST criteria

    5. Number of patient with grade 3/4 treatment-related toxicities [Up to 7 years]

      Evaluation according to CTCAE v5.0 classification

    6. Number of patients who received maintenance treatment in the first line [Up to 7 years]

    7. Number of patients who received second and third line treatment [Up to 7 years]

    Eligibility Criteria

    Criteria

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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 CHU Jean Minjoz Besançon France
    2 Hôpital Beaujon Clichy France
    3 CHU - Henri Mondor Créteil France
    4 CHU Lille Lille France
    5 Centre Léon Bérard Lyon France
    6 HRU Nancy Site Brabois Nancy France
    7 Hôpital Georges Pompidou Paris France
    8 Hôpital Saint Antoine Paris France
    9 Institut Mutualiste Montsouris Paris France
    10 CHU Poitiers Poitiers France
    11 CHU Reims Reims France
    12 CHU Pontchaillou Rennes France
    13 Institut Curie Saint-Cloud France
    14 IHU - Institut de chirurgie guidée par l'imagerie Strasbourg France
    15 Hôpital Paul Brousse Villejuif France

    Sponsors and Collaborators

    • GERCOR - Multidisciplinary Oncology Cooperative Group

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    GERCOR - Multidisciplinary Oncology Cooperative Group
    ClinicalTrials.gov Identifier:
    NCT05776342
    Other Study ID Numbers:
    • CANOPE GB-121
    First Posted:
    Mar 20, 2023
    Last Update Posted:
    Mar 20, 2023
    Last Verified:
    Mar 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:

    Study Results

    No Results Posted as of Mar 20, 2023