PancreasNCT02979483
Management of Symptomatic Advanced Pancreatic Adenocarcinoma
A study testing 14-EISCP in people with Pancreas and Management Supportive Care Program, run by GERCOR - Multidisciplinary Oncology Cooperative Group at 12 sites in France.
Trial summary
This study assessed the feasibility and effects of an early integrative supportive care program in patient with advanced pancreatic adenocarcinoma (aPDAC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreas, Management Supportive Care Program
- What is being tested?
- 14-EISCP
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 12 sitesFrance
- Study dates
- 19 Dec 2016to Sep 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
France12 sites
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
About this study
Official title: Management of Symptomatic Advanced Pancreatic Adenocarcinoma: "Urgence Pancreas" - A Prospective A.R.CA.D Cohort Study
This study assessed the feasibility and effects of an early integrative supportive care program in patient with advanced pancreatic adenocarcinoma (aPDAC).
Read the 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.
- Conditions
- Pancreas, Management Supportive Care Program
- Being tested
- 14-EISCP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
14-EISCPOther
The 14-EISCP starts with the end of the first visit medical for patients who have symptoms suspicious of or confirmed symptomatic aPDAC (ECOG PS ≥ 2 and/or initially ineligible for clinical trial, FOLFIRINOX or gemcitabine + nab-paclitaxel):
The The 14-EISCP will include:
- Pain management,
- Nutritional management,
- Pathological examination and site of biopsy,
- Imaging,
- Endoscopy for diagnosis purpose or for biliary/duodenal stenting.
After the 14-EISCP, patients will receive best supportive care or chemotherapy according to their ECOG PS status:
- 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
- ECOG-PS 2-4 and / or ineligible for clinical trial, FOLFIRINOX or gemcitabine + nab-paclitaxel Patients will be treated by: FOLFOX7 lightened
| Study group | Role | What they receive |
|---|---|---|
| 14-day emergency integrative supportive care program (14-EISCP) | Experimental | 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 Receives: Other: 14-EISCP |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of 14-EISCP success
The success is determined by:
Program Feasibility :
The 14-EISCP is considered feasible if the planned procedures, established during the initial consultation with the investigator, is completed within 14 days (+/- 2 days) following the first consultation, or before the start of chemotherapy if it started within 14 days.
and
Clinical Benefit at 30 days post-consultation defined by one of the following criteria:
- An improvement of ECOG PS from ≥2 to 1 or 0.
- A ≥5-point improvement in either fatigue, pain, or global health, as measured by the QLQ-C15-PAL, with no worsening in ECOG PS or the dimensions of fatigue, pain, and global health compared to baseline values.
- The initiation of chemotherapy within 30 days of consultation.
If none of the above criteria (1), (2), or (3) are met, the clinical benefit was considered absent, and the outcome was classified as a failure.
The success of the 14-EISCP was defined by success of both criteria.
Measured: 14 days (+/- 2 days)
Secondary outcomes (7)
Delay from the first symptom of aPDAC to the first medical appointment
Delay between first medical appointment and beginning of chemotherapy in days.
Measured: Up to 2-3 months
The rate of patients with improved ECOG PS and/or clinico-biological parameters after 14-EISCP.
The rate of patients with improved ECOG PS and clinico-biologic parameters (liver tests, including bilirubin) at the end of the integrative supportive care program.
Measured: 14 days; at the end of the 14-EISCP
The rate of patients receiving chemotherapy and rate of patients with type of chemotherapy effectively given after the 14-EISCP.
The rate of patients receiving chemotherapy and rate of patients with type of chemotherapy effectively given after the 14-EISCP.
Measured: At 14 days, at 21 days, up to death
The mean change of health-related quality of life (HRQoL) score
The mean change of HRQoL (QLQ-C15-PAL) score between the beginning and the end of the 14-EISCP.
Measured: at 30 days
Progression-free survival (PFS) assessment
PFS in different patient groups.
Measured: up to 2 years
Overall survival (OS) assessment
OS in different patient groups.
Measured: up to 2 years
The change of health-related quality of life (HRQoL)
The change of health-related quality of life (HRQoL) as measured by QLQ-C15 PAL. Mean change will be used to compare QoL scores before and after the 14-EISCP.
Measured: Month 1 and every two months up to two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2016 (estimated)
- Study start19 Dec 2016
- Primary completionJul 2022
- Study completionSep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PancreasStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- GERCOR - Multidisciplinary Oncology Cooperative Group
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Benoît ROUSSEAU, MD, Principal investigator, CHU Henri Mondor Créteil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02979483
- Sponsor's protocol ID
- Urgence Pancreas D16-1
- Status last verified
- Jun 2025
- First submitted
- 29 Nov 2016
- Last updated
- 13 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management of Symptomatic Advanced Pancreatic Adenocarcinoma: "Urgence Pancreas" - A Prospective A.R.CA.D Cohort Study
- ClinicalTrials.gov ID
- NCT02979483
- Acronym / sponsor ID
- Urgence Pancreas D16-1
- Conditions
- Pancreas, Management Supportive Care Program
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- GERCOR - Multidisciplinary Oncology Cooperative GroupUniversity, hospital or other
- Study start
- 19 Dec 2016 (actual)
- Primary completion
- Jul 2022 (actual)
- Study completion
- Sep 2025 (estimated)
- First posted
- 1 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 14-day emergency integrative supportive care program (14-EISCP) | Experimental | Other: 14-EISCPThe 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 14-EISCPThe 14-EISCP starts with the end of the first visit medical for patients who have symptoms suspicious of or confirmed symptomatic aPDAC (ECOG PS ≥ 2 and/or initially ineligible for clinical trial, FOLFIRINOX or gemcitabine + nab-paclitaxel): The The 14-EISCP will include: * Pain management, * Nutritional management, * Pathological examination and site of biopsy, * Imaging, * Endoscopy for diagnosis purpose or for biliary/duodenal stenting. After the 14-EISCP, patients will receive best supportive care or chemotherapy according to their ECOG PS status: * 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 * ECOG-PS 2-4 and / or ineligible for clinical trial, FOLFIRINOX or gemcitabine + nab-paclitaxel Patients will be treated by: FOLFOX7 lightened | Other | 14-day emergency integrative supportive care program (14-EISCP) |
Primary outcome
The rate of 14-EISCP success
Time frame: 14 days (+/- 2 days)
The success is determined by: Program Feasibility : The 14-EISCP is considered feasible if the planned procedures, established during the initial consultation with the investigator, is completed within 14 days (+/- 2 days) following the first consultation, or before the start of chemotherapy if it started within 14 days. and Clinical Benefit at 30 days post-consultation defined by one of the following criteria: 1. An improvement of ECOG PS from ≥2 to 1 or 0. 2. A ≥5-point improvement in either fatigue, pain, or global health, as measured by the QLQ-C15-PAL, with no worsening in ECOG PS or the dimensions of fatigue, pain, and global health compared to baseline values. 3. The initiation of chemotherapy within 30 days of consultation. If none of the above criteria (1), (2), or (3) are met, the clinical benefit was considered absent, and the outcome was classified as a failure. The success of the 14-EISCP was defined by success of both criteria.
7 secondary outcomes
Delay from the first symptom of aPDAC to the first medical appointment
Time frame: Up to 2-3 months
The rate of patients with improved ECOG PS and/or clinico-biological parameters after 14-EISCP.
Time frame: 14 days; at the end of the 14-EISCP
The rate of patients receiving chemotherapy and rate of patients with type of chemotherapy effectively given after the 14-EISCP.
Time frame: At 14 days, at 21 days, up to death
The mean change of health-related quality of life (HRQoL) score
Time frame: at 30 days
Progression-free survival (PFS) assessment
Time frame: up to 2 years
Overall survival (OS) assessment
Time frame: up to 2 years
The change of health-related quality of life (HRQoL)
Time frame: Month 1 and every two months up to two years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2025.
Related trials for Pancreas
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
RecruitingPhase 1
Modified FOLFIRINOX and Pentamidine in Advanced and Metastatic Pancreatic Cancer
Pancreatic Ductal Adenocarcinoma (PDAC)
RecruitingPhase 3
Atebimetinib + GnP as a First Line Treatment in Patients With Metastatic Pancreatic Adenocarcinoma
Pancreatic Cancer, Pancreatic Cancer Metastatic
RecruitingPhase 3
Lanreotide Versus Placebo Before Surgery to Prevent a Surgical Complication Called a Pancreatic Fistula
Pancreatic Carcinoma, Pancreatic Neoplasm
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Benoît ROUSSEAU, MD principal investigator
CHU Henri Mondor Créteil
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 14-EISCP in people with Pancreas and Management Supportive Care Program, run by GERCOR - Multidisciplinary Oncology Cooperative Group at 12 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 13 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of 14-EISCP success (time frame: 14 days (+/- 2 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2025.