NCT02979483

Management of Symptomatic Advanced Pancreatic Adenocarcinoma

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 110 (estimated)
• Sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Pancreas
• Management Supportive Care Program

Interventions

Type	Name	Description
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

Timeline

• Start date: 2016-12-19
• Primary completion: 2022-07-01
• Completion: 2025-09-01
• First posted: 2016-12-01
• Last updated: 2025-06-13

Locations

12 sites across 1 country: France