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

Status: Active_not_recruiting
Location: See all (12) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

This study assessed the feasibility and effects of an early integrative supportive care program in patient with advanced pancreatic adenocarcinoma (aPDAC).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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).

Locations
Other Locations
France
Institut Sainte Catherine
Avignon
Hôpital Beaujon
Clichy
Hôpital Henri Mondor
Créteil
Institut Hospitalier Franco-Britannique
Levallois Perret
Centre Léon Bérard
Lyon
CH Layne
Mont De Marsan
Grope Hospitalier Paris Saint Joseph
Paris
Hôpital Cochin
Paris
Hôpital Pitié Salpêtrière
Paris
Institut Mutualiste Montsouris
Paris
Hopitaux du Léman
Thonon Les Bains
CHU Tours - Hôpital Trousseau
Tours
Time Frame
Start Date: 2016-12-19
Completion Date: 2025-09
Participants
Target number of participants: 110
Treatments
Experimental: 14-day emergency integrative supportive care program (14-EISCP)
The 14-EISCP starts with the end of visit 1:~* The investigator must determine which procedures have to be undertaken within the following 14 days (+/- 2 days):~* Pain management,~* Nutritional management,~* Pathological examination and site of biopsy,~* Imaging,~* Endoscopy for diagnosis purpose or for biliary/duodenal stenting.~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
Sponsors
Leads: GERCOR - Multidisciplinary Oncology Cooperative Group

This content was sourced from clinicaltrials.gov

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