Management of Symptomatic Advanced Pancreatic Adenocarcinoma

Pancreas Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02979483
• Other study ID #: Urgence Pancreas D16-1
• Status: Recruiting
• Phase: N/A
• Start date: November 2016
• Est. completion date: October 2020

Study information

• Verified date: February 2019
• Source: GERCOR - Multidisciplinary Oncology Cooperative Group
• Contact: Benoît ROUSSEAU, MD
• Email: benoit.rousseau[@]aphp.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 110
• Est. completion date: October 2020
• Est. primary completion date: July 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adenocarcinoma
• Management Supportive Care Program
• Pancreas

Intervention

Procedure:
• Integrative supportive care
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

Locations

Country	Name	City	State
France	Institut Sainte Catherine	Avignon
France	Hôpital Beaujon	Clichy
France	Hôpital Henri Mondor	Créteil
France	Institut Hospitalier Franco-Britannique	Levallois Perret
France	Centre Léon Bérard	Lyon
France	CH Layne	Mont de Marsan
France	Grope Hospitalier Paris Saint Joseph	Paris
France	Hôpital Cochin	Paris
France	Hôpital Pitié Salpêtrière	Paris
France	Institut Mutualiste Montsouris	Paris
France	Hopitaux du Léman	Thonon les Bains
France	CHU Tours - Hôpital Trousseau	Tours

Sponsors (1)

Lead Sponsor	Collaborator
GERCOR - Multidisciplinary Oncology Cooperative Group

Country where clinical trial is conducted

France, 

Outcome

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