Management of Symptomatic Advanced Pancreatic Adenocarcinoma

June 12, 2025 updated by: GERCOR - Multidisciplinary Oncology Cooperative Group

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

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

110

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Avignon, France
        • Institut Sainte Catherine
      • Clichy, France
        • Hopital Beaujon
      • Créteil, France
        • Hopital Henri Mondor
      • Levallois Perret, France
        • Institut Hospitalier Franco-Britannique
      • Lyon, France
        • Centre Léon Bérard
      • Mont de Marsan, France
        • CH Layné
      • Paris, France
        • Institut Mutualiste Montsouris
      • Paris, France
        • Hopital Pitie Salpetriere
      • Paris, France
        • Hôpital Cochin
      • Paris, France
        • Grope Hospitalier Paris Saint Joseph
      • Thonon les Bains, France
        • Hopitaux du Leman
      • Tours, France
        • CHU Tours - Hôpital Trousseau

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion criteria

  1. 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,
  2. Age ≥ 18 years,
  3. Patients with ECOG PS ≥ 2 and clinico-biological features precluding initial therapeutic clinical trial and/or treatment with FOLFIRINOX or gemcitabine + nab-paclitaxel,
  4. 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.
  5. Registration in France with the French National Health Care System (CMU included)
  6. Patient able to comply with study protocol requirements in the view of the investigator,
  7. Before patient registration, written informed consent must be obtained according to ICH/GCP and national/local regulations,
  8. Patients requiring at least two components of the integrative care program (pain management, nutritional management, pathological assessment or imaging, and endoscopy/stent).

Exclusion criteria:

  1. 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,
  2. Patient protected by law,
  3. Pregnant or breast feeding women

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 14-day emergency integrative supportive care program (14-EISCP)

The 14-EISCP starts with the end of visit 1:

  • The investigator must determine which procedures have to be undertaken within the following 14 days (+/- 2 days):
  • Pain management,
  • Nutritional management,
  • Pathological examination and site of biopsy,
  • Imaging,
  • Endoscopy for diagnosis purpose or for biliary/duodenal stenting.

At the end of the visit the investigator must plan all the supportive care and procedures indicated for the patient and indicate those within a specific form
Other: 14-EISCP

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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:

  1. An improvement of ECOG PS from ≥2 to 1 or 0.
  2. 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.
  3. 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.
14 days (+/- 2 days)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 2-3 months
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.
14 days; at the end of the 14-EISCP
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.
At 14 days, at 21 days, up to death
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.
at 30 days
Progression-free survival (PFS) assessment
Time Frame: up to 2 years
PFS in different patient groups.
up to 2 years
Overall survival (OS) assessment
Time Frame: up to 2 years
OS in different patient groups.
up to 2 years
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.
Month 1 and every two months up to two years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GERCOR - Multidisciplinary Oncology Cooperative Group

Investigators

  • Principal Investigator: Benoît ROUSSEAU, MD, CHU Henri Mondor Créteil

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 19, 2016

Primary Completion (Actual)

July 1, 2022

Study Completion (Estimated)

September 1, 2025

Study Registration Dates

First Submitted

November 29, 2016

First Submitted That Met QC Criteria

November 29, 2016

First Posted (Estimated)

December 1, 2016

Study Record Updates

Last Update Posted (Actual)

June 13, 2025

Last Update Submitted That Met QC Criteria

June 12, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Urgence Pancreas D16-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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