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This study assessed the feasibility and effects of an early integrative supportive care program in patient with advanced pancreatic adenocarcinoma (aPDAC).
This is a national, multicenter, prospective study, including:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 14-day emergency integrative supportive care program (14-EISCP) | Experimental | The 14-EISCP starts with the end of visit 1:
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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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:
After the 14-EISCP, patients will receive best supportive care or chemotherapy according to their ECOG PS status:
|
| Measure | Description | Time Frame |
|---|---|---|
| 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:
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) |
| Measure | Description | Time Frame |
|---|---|---|
| Delay from the first symptom of aPDAC to the first medical appointment | 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. |
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Inclusion criteria
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Benoît ROUSSEAU, MD | CHU Henri Mondor Créteil | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut Sainte Catherine | Avignon | France | ||||
| Hôpital Beaujon |
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|
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. | 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 | 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 | PFS in different patient groups. | up to 2 years |
| Overall survival (OS) assessment | OS in different patient groups. | up to 2 years |
| The change of health-related quality of life (HRQoL) | 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 |
| Clichy |
| France |
| Hôpital Henri Mondor | Créteil | France |
| Institut Hospitalier Franco-Britannique | Levallois-Perret | France |
| Centre Léon Bérard | Lyon | France |
| CH Layne | Mont-de-Marsan | France |
| Grope Hospitalier Paris Saint Joseph | Paris | France |
| Hôpital Cochin | Paris | France |
| Hôpital Pitié Salpêtrière | Paris | France |
| Institut Mutualiste Montsouris | Paris | France |
| Hopitaux du Léman | Thonon-les-Bains | France |
| CHU Tours - Hôpital Trousseau | Tours | France |