Management of Symptomatic Advanced Pancreatic Adenocarcinoma

NCT02979483 | Active Not Recruiting

• 1 other identifier: Urgence Pancreas D16-1
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 12

Brief Summary

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

Conditions

Pancreas; Management Supportive Care Program

Outcome Measures

Primary Outcomes (1)

• The rate of 14-EISCP success

  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 Outcomes (7)

• Delay from the first symptom of aPDAC to the first medical appointment

  Up to 2-3 months

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

  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.

  At 14 days, at 21 days, up to death

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

  at 30 days

• Progression-free survival (PFS) assessment

  up to 2 years

Study Arms (1)

14-day emergency integrative supportive care program (14-EISCP)

EXPERIMENTAL

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

Interventions

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

14-day emergency integrative supportive care program (14-EISCP)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• GERCOR - Multidisciplinary Oncology Cooperative Group: lead

Study Sites (12)

Institut Sainte Catherine

Avignon, France

Location

Hôpital Beaujon

Clichy, France

Location

Hôpital Henri Mondor

Créteil, France

Location

Institut Hospitalier Franco-Britannique

Levallois-Perret, France

Location

Centre Léon Bérard

Lyon, France

Location

CH Layne

Mont-de-Marsan, France

Location

Grope Hospitalier Paris Saint Joseph

Paris, France

Location

Hôpital Cochin

Paris, France

Location

Hôpital Pitié Salpêtrière

Paris, France

Location

Institut Mutualiste Montsouris

Paris, France

Location

Hopitaux du Léman

Thonon-les-Bains, France

Location

CHU Tours - Hôpital Trousseau

Tours, France

Location

Study Officials

• Benoît ROUSSEAU, MD

  CHU Henri Mondor Créteil

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2016
• First Posted: December 1, 2016
• Study Start: December 19, 2016
• Primary Completion: July 1, 2022
• Study Completion: September 1, 2025
• Last Updated: June 13, 2025

Record last verified: 2025-06

Locations

FR (12)