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NCT Number: NCT02979483

Management of Symptomatic Advanced Pancreatic Adenocarcinoma

This study assessed the feasibility and effects of an early integrative supportive care program in patient with advanced pancreatic adenocarcinoma (aPDAC).

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Pancreas Management Supportive Care Program

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institut Sainte Catherine, Avignon, France

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About this study

This is a national, multicenter, prospective study, including:

  • A 14-day (+/-2 days) integrative supportive care program (14-EISCP) initiated as early as the clinical suspicion of aPDAC,
  • Follow-up period after the 14-EISCP.

ECOG PS ≥2 patients with pathologically confirmed or suspected aPDAC on imaging were included at first oncology visit in the 14-EISCP including pain, nutritional, diagnostic and stenting procedures.

Post-EISCP ECOG PS ≤1 patients received mFOLFIRINOX or gemcitabine/nab-paclitaxel, ECOG PS ≥2 patients received mFOLFOX7 or investigator choice chemotherapy or best supportive care.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Pathologically confirmed or highly suspected aPDAC defined as a pancreatic mass on imaging, suspected distant metastases, no features suggestive of a neuroendocrine tumor, and/or clinico-biological abnormalities compatible with the diagnosis of aPDAC,
  • Age ≥ 18 years,
  • Patients with ECOG PS ≥ 2 and clinico-biological features precluding initial therapeutic clinical trial and/or treatment with FOLFIRINOX or gemcitabine + nab-paclitaxel,
  • No prior history of cancer, except: in situ breast, cervix cancer, or basal cell carcinoma and/or complete remission for more than 3 years from another cancer.
  • Registration in France with the French National Health Care System (CMU included)
  • Patient able to comply with study protocol requirements in the view of the investigator,
  • Before patient registration, written informed consent must be obtained according to ICH/GCP and national/local regulations,
  • Patients requiring at least two components of the integrative care program (pain management, nutritional management, pathological assessment or imaging, and endoscopy/stent).

Exclusion criteria

  • Any medical, psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow- up schedule; those conditions should be discussed with the patient before registration in the trial,
  • Patient protected by law,
  • Pregnant or breast feeding women

Treatment and study plan

14-EISCP

Other

The 14-EISCP starts with the end of the first visit medical for patients who have symptoms suspicious of or confirmed symptomatic aPDAC (ECOG PS ≥ 2 and/or initially ineligible for clinical trial, FOLFIRINOX or gemcitabine + nab-paclitaxel):

The The 14-EISCP will include:

  • Pain management,
  • Nutritional management,
  • Pathological examination and site of biopsy,
  • Imaging,
  • Endoscopy for diagnosis purpose or for biliary/duodenal stenting.

After the 14-EISCP, patients will receive best supportive care or chemotherapy according to their ECOG PS status:

  • ECOG-PS 0-1 and eligible for clinical trial, FOLFIRINOX or gemcitabine + nab-paclitaxel Patient will be treated by : FOLFIRINOX or gemcitabine-nab-paclitaxel or clinical trial
  • ECOG-PS 2-4 and / or ineligible for clinical trial, FOLFIRINOX or gemcitabine + nab-paclitaxel Patients will be treated by: FOLFOX7 lightened

Primary outcomes

  1. The rate of 14-EISCP success

    Time frame: 14 days (+/- 2 days)

    The success is determined by:

    Program Feasibility :

    The 14-EISCP is considered feasible if the planned procedures, established during the initial consultation with the investigator, is completed within 14 days (+/- 2 days) following the first consultation, or before the start of chemotherapy if it started within 14 days.

    and

    Clinical Benefit at 30 days post-consultation defined by one of the following criteria:

    • An improvement of ECOG PS from ≥2 to 1 or 0.
    • A ≥5-point improvement in either fatigue, pain, or global health, as measured by the QLQ-C15-PAL, with no worsening in ECOG PS or the dimensions of fatigue, pain, and global health compared to baseline values.
    • The initiation of chemotherapy within 30 days of consultation.

    If none of the above criteria (1), (2), or (3) are met, the clinical benefit was considered absent, and the outcome was classified as a failure.

    The success of the 14-EISCP was defined by success of both criteria.

Secondary outcomes

  1. Delay from the first symptom of aPDAC to the first medical appointment

    Time frame: Up to 2-3 months

    Delay between first medical appointment and beginning of chemotherapy in days.

  2. The rate of patients with improved ECOG PS and/or clinico-biological parameters after 14-EISCP.

    Time frame: 14 days; at the end of the 14-EISCP

    The rate of patients with improved ECOG PS and clinico-biologic parameters (liver tests, including bilirubin) at the end of the integrative supportive care program.

  3. The rate of patients receiving chemotherapy and rate of patients with type of chemotherapy effectively given after the 14-EISCP.

    Time frame: At 14 days, at 21 days, up to death

    The rate of patients receiving chemotherapy and rate of patients with type of chemotherapy effectively given after the 14-EISCP.

  4. The mean change of health-related quality of life (HRQoL) score

    Time frame: at 30 days

    The mean change of HRQoL (QLQ-C15-PAL) score between the beginning and the end of the 14-EISCP.

  5. Progression-free survival (PFS) assessment

    Time frame: up to 2 years

    PFS in different patient groups.

  6. Overall survival (OS) assessment

    Time frame: up to 2 years

    OS in different patient groups.

  7. The change of health-related quality of life (HRQoL)

    Time frame: Month 1 and every two months up to two years

    The change of health-related quality of life (HRQoL) as measured by QLQ-C15 PAL. Mean change will be used to compare QoL scores before and after the 14-EISCP.

Sponsors and collaborators

Lead sponsor

GERCOR - Multidisciplinary Oncology Cooperative Group

Other

Registry information

Official study title

Management of Symptomatic Advanced Pancreatic Adenocarcinoma: "Urgence Pancreas" - A Prospective A.R.CA.D Cohort Study

Important dates

Study start
2016
Primary completion
2022
Study completion
2025
First posted
Dec 1, 2016
Registry last updated
Jun 13, 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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