Clinical trial NCT02979483: Management of Symptomatic Advanced Pancreatic Adenocarcinoma
Official title: Management of Symptomatic Advanced Pancreatic Adenocarcinoma: "Urgence Pancreas" - A Prospective A.R.CA.D Cohort Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Pancreas
Management Supportive Care Program
Lead sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group
Sponsor class: OTHER
First posted: 2016-12-01
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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

Primary outcomes:
measure: The rate of 14-EISCP success
timeFrame: 14 days (+/- 2 days)
Secondary outcomes:
measure: Delay from the first symptom of aPDAC to the first medical appointment
timeFrame: Up to 2-3 months
measure: The rate of patients with improved ECOG PS and/or clinico-biological parameters after 14-EISCP.
timeFrame: 14 days; at the end of the 14-EISCP
measure: The rate of patients receiving chemotherapy and rate of patients with type of chemotherapy effectively given after the 14-EISCP.
timeFrame: At 14 days, at 21 days, up to death
measure: The mean change of health-related quality of life (HRQoL) score
timeFrame: at 30 days
measure: Progression-free survival (PFS) assessment
timeFrame: up to 2 years
measure: Overall survival (OS) assessment
timeFrame: up to 2 years
measure: The change of health-related quality of life (HRQoL)
timeFrame: Month 1 and every two months up to two years
Other outcomes:
Locations:
city: Avignon
country: France
facility: Institut Sainte Catherine
city: Clichy
country: France
facility: Hôpital Beaujon
city: Créteil
country: France
facility: Hôpital Henri Mondor
city: Levallois Perret
country: France
facility: Institut Hospitalier Franco-Britannique
city: Lyon
country: France
facility: Centre Léon Bérard
city: Mont de Marsan
country: France
facility: CH Layne
city: Paris
country: France
facility: Grope Hospitalier Paris Saint Joseph
city: Paris
country: France
facility: Hôpital Cochin
city: Paris
country: France
facility: Hôpital Pitié Salpêtrière
city: Paris
country: France
facility: Institut Mutualiste Montsouris
city: Thonon les Bains
country: France
facility: Hopitaux du Léman
city: Tours
country: France
facility: CHU Tours - Hôpital Trousseau
Study officials:
affiliation: CHU Henri Mondor Créteil
name: Benoît ROUSSEAU, MD
role: PRINCIPAL_INVESTIGATOR
References: