Management of Symptomatic Advanced Pancreatic Adenocarcinoma

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02979483
• Date of registration: 29/11/2016
• Prospective Registration: No
• Primary sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group
• Public title: Management of Symptomatic Advanced Pancreatic Adenocarcinoma
• Scientific title: Management of Symptomatic Advanced Pancreatic Adenocarcinoma: "Urgence Pancreas" - A Prospective A.R.CA.D Cohort Study
• Date of first enrolment: November 2016
• Target sample size: 110
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT02979483
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Health Services Research. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

France

Contacts

• Name: Benoît ROUSSEAU, MD

• Name: Benoît ROUSSEAU, MD
• Affiliation: CHU Henri Mondor Créteil

Key inclusion & exclusion criteria

Inclusion Criteria - STEP 1:

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 - STEP 1 :

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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Pancreas

Management Supportive Care Program

Intervention(s)

Procedure: Integrative supportive care

Primary Outcome(s)

STEP 2 : 3-month Overall Survival rate [Time Frame: Up to 3 months after the beginning of the chemotherapy]

STEP 1 : Success rate (feasibility + clinical benefit) of the 14-day integrative supportive care program [Time Frame: 14 days (+/- 2 days)]

Secondary Outcome(s)

Rate of patient included in each group [Time Frame: up to two years (after the recruitment of all patients)]

Delay from first symptom of aPDAC to first medical appointment [Time Frame: Up to 2-3 months]

Score of HRQoL (QLQ-C15 PAL) [Time Frame: Month 1 and every two months up to two years]

Rate of patients included in a clinical trial [Time Frame: Up to 14 days]

Progression free survival in each group [Time Frame: up to two years]

Comparison score of Health-related quality of life (HRQoL) [Time Frame: Between the score of HRQoL before the program and the score of HRQoL at the end of the 14 days program]

Delay from first medical appointment to beginning of chemotherapy [Time Frame: Up to 1 month]

Overall survival in each group [Time Frame: up to two years]

Type of chemotherapy administered [Time Frame: Up to 14 days]

Rate of patients improvement of ECOG PS and clinico-biologic parameters [Time Frame: Up to 14-day]

Rate of patients receiving chemotherapy [Time Frame: At 14 days, at 21 days, Up to death]

Secondary ID(s)

Urgence Pancreas D16-1

Source(s) of Monetary Support

Please refer to primary and secondary sponsors