Management Supportive Care Program, Pancreas
Conditions
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.
Interventions
OTHER14-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
Sponsors
GERCOR - Multidisciplinary Oncology Cooperative Group
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| Progression-free survival (PFS) assessment | up to 2 years | PFS in different patient groups. |
Countries
France
Outcome results
None listed