Management of Symptomatic Advanced Pancreatic Adenocarcinoma

Not Applicable

Active, not recruiting

• Conditions: Management Supportive Care Program; Pancreas
• Interventions: Procedure: Integrative supportive care

• Registration Number: NCT02979483
• Lead Sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group

Brief 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.

Study Timeline

• Study First Submitted: 2016-11-29
• Study First Submitted QC: 2016-11-29
• Study First Posted: 2016-12-01
• Study Start: 2016-12-19
• Primary Completion: 2022-07
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-21
• Last Update Posted: 2025-03-25
• Study Completion: 2025-04

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Integrative Supportive Care	Integrative supportive care	All planed procedures established during the first consultation with the investigator is successfully completed within the 14-day (+/-2 days)

Primary Outcome Measures

Name	Time	Method
The rate of 14-EISCP success	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.

Secondary Outcome Measures

Name	Time	Method
Delay from the first symptom of aPDAC to the first medical appointment	Up to 2-3 months	Delay between first medical appointment and beginning of chemotherapy in days.
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 with improved ECOG PS and clinico-biologic parameters (liver tests, including bilirubin) at the end of the integrative supportive care program.
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 rate of patients receiving chemotherapy and rate of patients with type of chemotherapy effectively given after the 14-EISCP.
The mean change of health-related quality of life (HRQoL) score	at 30 days	The mean change of HRQoL (QLQ-C15-PAL) score between the beginning and the end of the 14-EISCP.
Progression-free survival (PFS) assessment	up to 2 years	PFS in different patient groups.
Overall survival (OS) assessment	up to 2 years	OS in different patient groups.
The change of health-related quality of life (HRQoL)	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.

Trial Locations

Locations (12)

Institut Mutualiste Montsouris; 🇫🇷 Paris, France

Hopitaux du Léman; 🇫🇷 Thonon les Bains, France

CHU Tours - Hôpital Trousseau; 🇫🇷 Tours, France

CH Layne; 🇫🇷 Mont de Marsan, France

Grope Hospitalier Paris Saint Joseph; 🇫🇷 Paris, France

Hôpital Cochin; 🇫🇷 Paris, France

Hôpital Pitié Salpêtrière; 🇫🇷 Paris, France

Institut Sainte Catherine; 🇫🇷 Avignon, France

Hôpital Beaujon; 🇫🇷 Clichy, France

Hôpital Henri Mondor; 🇫🇷 Créteil, France

Institut Hospitalier Franco-Britannique; 🇫🇷 Levallois Perret, France

Centre Léon Bérard; 🇫🇷 Lyon, France