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Management of Symptomatic Advanced Pancreatic Adenocarcinoma

Primary Purpose

Pancreas, Management Supportive Care Program

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Integrative supportive care
Sponsored by
GERCOR - Multidisciplinary Oncology Cooperative Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Pancreas

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Institut Sainte Catherine
  • Hôpital Beaujon
  • Hôpital Henri MondorRecruiting
  • Institut Hospitalier Franco-BritanniqueRecruiting
  • Centre Léon Bérard
  • CH Layne
  • Grope Hospitalier Paris Saint JosephRecruiting
  • Hôpital Cochin
  • Hôpital Pitié SalpêtrièreRecruiting
  • Institut Mutualiste Montsouris
  • Hopitaux du LémanRecruiting
  • CHU Tours - Hôpital TrousseauRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Integrative Supportive Care

Arm Description

All planed procedures established during the first consultation with the investigator is successfully completed within the 14-day (+/-2 days)

Outcomes

Primary Outcome Measures

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)
STEP 2 : 3-month Overall Survival rate

Secondary Outcome Measures

Delay from first symptom of aPDAC to first medical appointment
Delay from first medical appointment to beginning of chemotherapy
Rate of patients improvement of ECOG PS and clinico-biologic parameters
for biologic : livers tests, including bilirubin
Rate of patients receiving chemotherapy
Type of chemotherapy administered
type of chemotherapy : FOLFIRINOX, nab-paclitaxel + gemcitabine, gemcitabine alone, FOLFOX7 light or only best supportive care
Rate of patients included in a clinical trial
Comparison score of Health-related quality of life (HRQoL)
Rate of patient included in each group
Progression free survival in each group
Overall survival in each group
Score of HRQoL (QLQ-C15 PAL)

Full Information

First Posted
November 29, 2016
Last Updated
February 26, 2019
Sponsor
GERCOR - Multidisciplinary Oncology Cooperative Group
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1. Study Identification

Unique Protocol Identification Number
NCT02979483
Brief Title
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

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Unknown status
Study Start Date
November 2016 (undefined)
Primary Completion Date
July 2020 (Anticipated)
Study Completion Date
October 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GERCOR - Multidisciplinary Oncology Cooperative Group

4. Oversight

Data Monitoring Committee
No

5. Study Description

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
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreas, Management Supportive Care Program

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
110 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Integrative Supportive Care
Arm Type
Other
Arm Description
All planed procedures established during the first consultation with the investigator is successfully completed within the 14-day (+/-2 days)
Intervention Type
Procedure
Intervention Name(s)
Integrative supportive care
Intervention Description
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
Primary Outcome Measure Information:
Title
STEP 1 : Success rate (feasibility + clinical benefit) of the 14-day integrative supportive care program
Description
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)
Time Frame
14 days (+/- 2 days)
Title
STEP 2 : 3-month Overall Survival rate
Time Frame
Up to 3 months after the beginning of the chemotherapy
Secondary Outcome Measure Information:
Title
Delay from first symptom of aPDAC to first medical appointment
Time Frame
Up to 2-3 months
Title
Delay from first medical appointment to beginning of chemotherapy
Time Frame
Up to 1 month
Title
Rate of patients improvement of ECOG PS and clinico-biologic parameters
Description
for biologic : livers tests, including bilirubin
Time Frame
Up to 14-day
Title
Rate of patients receiving chemotherapy
Time Frame
At 14 days, at 21 days, Up to death
Title
Type of chemotherapy administered
Description
type of chemotherapy : FOLFIRINOX, nab-paclitaxel + gemcitabine, gemcitabine alone, FOLFOX7 light or only best supportive care
Time Frame
Up to 14 days
Title
Rate of patients included in a clinical trial
Time Frame
Up to 14 days
Title
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
Title
Rate of patient included in each group
Time Frame
up to two years (after the recruitment of all patients)
Title
Progression free survival in each group
Time Frame
up to two years
Title
Overall survival in each group
Time Frame
up to two years
Title
Score of HRQoL (QLQ-C15 PAL)
Time Frame
Month 1 and every two months up to two years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Benoît ROUSSEAU, MD
Email
benoit.rousseau@aphp.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Benoît ROUSSEAU, MD
Organizational Affiliation
CHU Henri Mondor Créteil
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institut Sainte Catherine
City
Avignon
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Philippe DEBOURDEAU, MD
First Name & Middle Initial & Last Name & Degree
Philippe DEBOURDEAU, MD
Facility Name
Hôpital Beaujon
City
Clichy
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pascal HAMMEL, MD
First Name & Middle Initial & Last Name & Degree
Pascal HAMMEL, MD
Facility Name
Hôpital Henri Mondor
City
Créteil
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Benoît ROUSSEAU, MD
First Name & Middle Initial & Last Name & Degree
Benoît ROUSSEAU, MD
Facility Name
Institut Hospitalier Franco-Britannique
City
Levallois Perret
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aimery DE GRAMONT, MD
First Name & Middle Initial & Last Name & Degree
Aimery DE GRAMONT, MD
Facility Name
Centre Léon Bérard
City
Lyon
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christelle De la FOUCHARDIERE, MD
First Name & Middle Initial & Last Name & Degree
Christelle de la FOUCHARDIERE, MD
Facility Name
CH Layne
City
Mont de Marsan
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jérôme DAUBA, MD
First Name & Middle Initial & Last Name & Degree
Jérôme DAUBA, MD
Facility Name
Grope Hospitalier Paris Saint Joseph
City
Paris
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eric RAYMOND, MD
First Name & Middle Initial & Last Name & Degree
Eric RAYMOND, MD
Facility Name
Hôpital Cochin
City
Paris
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Romain CORIAT, MD
First Name & Middle Initial & Last Name & Degree
Romain CORIAT, MD
Facility Name
Hôpital Pitié Salpêtrière
City
Paris
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean Baptiste BACHET, MD
First Name & Middle Initial & Last Name & Degree
Jean Baptiste BACHET, MD
Facility Name
Institut Mutualiste Montsouris
City
Paris
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christophe LOUVET, MD
First Name & Middle Initial & Last Name & Degree
Christophe LOUVET, MD
Facility Name
Hopitaux du Léman
City
Thonon les Bains
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ahmed BEDJAOUI, MD
First Name & Middle Initial & Last Name & Degree
Ahmed BEDJAOUI, MD
Facility Name
CHU Tours - Hôpital Trousseau
City
Tours
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thierry LECOMTE, MD
First Name & Middle Initial & Last Name & Degree
Thierry LECOMTE, MD

12. IPD Sharing Statement

Learn more about this trial

Management of Symptomatic Advanced Pancreatic Adenocarcinoma

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