Management of Symptomatic Advanced Pancreatic Adenocarcinoma

Study Overview
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Brief Summary
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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).

Detailed Description
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Two-step cohort study: * Step 1 : A 14-day integrative supportive care program initiated as early as the clinical suspicion of aPDAC. According to the investigator's assessment of patient needs, this integrative supportive care program will include: management of pain nutritional support pathologic diagnosis (endoscopy guides or percutaneous biopsies or ascitis cytology) diagnostic computed imaging endoscopic stenting of the bile duct and/or duodenum * Step 2 : Follow up after the integrative supportive care program. According to their Eastern Cooperative Oncology Group Performance Status(ECOG PS) and/or chemotherapy Group 1 : Patient becoming eligible for treatment with FOLFIRINOX or nab-paclitaxel + gemcitabine and / or clinical trial Group 2 :Patient at the end of the 14-day program (Step 1) remaining with either : a - Persisting ECOG PS ≥ 2 b - Clinico-biological features that make them ineligible to receive the FOLFIRINOX or nab-paclitaxel + gemcitabine regimens c - Patient ineligible to other therapeutic clinical trial

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

Conditions
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Pancreas, Management Supportive Care Program

Intervention / Treatment
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* Procedure: Integrative supportive care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria - STEP 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, Age ≥ 18 years, Patients with ECOG PS ≥ 2 and clinico-biological features precluding initial therapeutic clinical trial and/or treatment with FOLFIRINOX or gemcitabine + nab-paclitaxel, 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. Registration in France with the French National Health Care System (CMU included) Patient able to comply with study protocol requirements in the view of the investigator, Before patient registration, written informed consent must be obtained according to ICH/GCP and national/local regulations, Patients requiring at least two components of the integrative care program (pain management, nutritional management, pathological assessment or imaging, and endoscopy/stent). Exclusion Criteria - STEP 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, Patient protected by law, Pregnant or breast feeding women

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Integrative Supportive Care<br>All planed procedures established during the first consultation with the investigator is successfully completed within the 14-day (+/-2 days) | Procedure: Integrative supportive care<br>* At the inclusion, the investigator determine a personalized program of supportive care procedures for each patient (for instance : treatment of pain and nutritional support,stenting of bile duct and/or duodenum, tumor biopsy for pathologic diagnosis ,..) At the end on the integrative supportive care, according to the ECOG-PS of patients , they will be classified into two groups: Group 1 :Good prognosis - 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 - Group 2 : Poor prognosis - ECOG-PS 2-4 and / or ineligible for clinical trial, FOLFIRINOX or gemcitabine + nab-paclitaxel. Patients will be treated by: FOLFOX7lightened<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| STEP 1 : Success rate (feasibility + clinical benefit) of the 14-day integrative supportive care program | Success of the integrative supportive care program following the first medical appointment in patients who have evocative symptom or pathologically confirmed symptomatic Advanced pancreatic adenocarcinoma (aPDAC) | 14 days (+/- 2 days) | 
| STEP 2 : 3-month Overall Survival rate |  | Up to 3 months after the beginning of the chemotherapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Delay from first symptom of aPDAC to first medical appointment |  | Up to 2-3 months | 
| Delay from first medical appointment to beginning of chemotherapy |  | Up to 1 month | 
| Rate of patients improvement of ECOG PS and clinico-biologic parameters | for biologic : livers tests, including bilirubin | Up to 14-day | 
| Rate of patients receiving chemotherapy |  | At 14 days, at 21 days, Up to death | 
| Type of chemotherapy administered | type of chemotherapy : FOLFIRINOX, nab-paclitaxel + gemcitabine, gemcitabine alone, FOLFOX7 light or only best supportive care | Up to 14 days | 
| Rate of patients included in a clinical trial |  | Up to 14 days | 
| Comparison score of Health-related quality of life (HRQoL) |  | Between the score of HRQoL before the program and the score of HRQoL at the end of the 14 days program | 
| Rate of patient included in each group |  | up to two years (after the recruitment of all patients) | 
| Progression free survival in each group |  | up to two years | 
| Overall survival in each group |  | up to two years | 
| Score of HRQoL (QLQ-C15 PAL) |  | Month 1 and every two months up to two years |