Management of Symptomatic Advanced Pancreatic Adenocarcinoma

GERCOR - Multidisciplinary Oncology Cooperative Group

Status: Active, not recruiting

Conditions: Management Supportive Care Program; Pancreas

Treatments: Other: 14-EISCP

Study type: Interventional

Funder types: Other

Identifiers

NCT02979483

Urgence Pancreas D16-1

Details and patient eligibility

About

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

Full 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.

Enrollment: 110 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Health Services Research

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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110 participants in 1 patient group

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

Experimental group

Description:

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

Treatment:

Other: 14-EISCP