Pancreatic CancerRADIOPANNCT07243288
Evaluation of an Early Radiomic Signature in Patients With Metastatic Pancreatic Adenocarcinoma Treated With First-line Chemotherapy
An observational study of Pancreatic Cancer and MeSH Term-Pancreatic Cancer, Adult), run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Pancreatic cancer, which has a poor prognosis, is becoming increasingly common in industrialized countries. Chemotherapy is the main treatment available for metastatic disease. Response to chemotherapy is currently assessed using imaging to monitor changes in the size of lesions undergoing treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer, MeSH Term-Pancreatic Cancer, Adult)
- What is being tested?
- Patients treated with FOLFOX or FOLFIRINOX in first line and Patients treated with GEMCITABINE in first line
- How many people
- 400 participants
- Where
- 1 siteFrance
- Study dates
- 9 Jan 2024to Dec 2026
- Phase
- Observational
- 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
Study population: Patients diagnosed with pancreatic cancer across all AP-HP hospitals. Data will be collected retrospectively from the AP-HP Clinical Data Warehouse (EDS).
Who may be able to join
- Adult patients (≥18 years)
- Diagnosis of acute alcoholic hepatitis (ICD10 C25) in a pathology report, followed by manual verification in clinical documents
Who cannot join
- Patients younger than 18 years at diagnosis
Trial locations and contacts
1 site in 1 country.
About this study
Pancreatic cancer, which has a poor prognosis, is becoming increasingly common in industrialized countries. Chemotherapy is the main treatment available for metastatic disease. Response to chemotherapy is currently assessed using imaging to monitor changes in the size of lesions undergoing treatment. Radiomics is a new method of analyzing quantitative data extracted from imaging that can be used to develop prediction algorithms and evaluate response to treatment. There is little robust radiomics data available for evaluating response to first-line treatments for pancreatic adenocarcinoma. Our main hypothesis is that quantifying tumor-related architectural changes could enable early identification of patients who will not respond to chemotherapy.
Read the detailed description
Pancreatic adenocarcinoma is a cancer with a poor prognosis, and its incidence is increasing, particularly in industrialized countries. Systemic chemotherapy, the main treatment available, has improved survival in patients with metastatic pancreatic adenocarcinoma. Following the results of the study by Conroy et al., the combination of 5FU + oxaliplatin + irinotecan (FOLFIRINOX) is one of the standard first-line chemotherapy regimens for metastatic pancreatic adenocarcinoma.
The population of patients with metastatic pancreatic adenocarcinoma is heterogeneous, with different survival profiles. This is part of a multifactorial picture that is still poorly understood (molecular, terrain, other factors, etc.). Response to chemotherapy is currently assessed using the RECIST 1.1 method, which takes into account changes in the size of lesions during treatment. However, this method is sometimes limited, as it does not always take into account the underlying pathophysiology.
Radiomics consists of analyzing quantitative data extracted from imaging, which allows prediction algorithms to be developed. Several studies have suggested that tumor architecture could be a biomarker of response and survival in patients with esophageal, lung, or colorectal cancer.
A study of 41 patients with advanced pancreatic cancer treated with gemcitabine-based chemotherapy evaluated the impact of radiological architectural assessment on treatment response. The results showed that tumor size, asymmetry, and standard deviation of density at baseline were associated with progression-free survival, and that tumor size and standard deviation of density at baseline were associated with overall survival. These results remain to be confirmed in a larger population, hence the value of conducting our work with data from our database.
Our main hypothesis is that quantifying tumor-related architectural changes could enable early identification of patients who will not respond to treatment. The overall objective would be to tailor the therapeutic strategy to each individual patient.
- Being tested
- Patients treated with FOLFOX or FOLFIRINOX in first line, Patients treated with GEMCITABINE in first line
- Keywords
- Pancreatic cancer, Radiomics, RWE epidemiology, Prognosis prediction
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patients treated with FOLFOX or FOLFIRINOX in first lineDrug
Treatment with FOLFOX or FOLFIRINOX (chemotherapy protocols) in first line
Patients treated with GEMCITABINE in first lineDrug
Treatment with GEMCITABINE (chemotherapy protocols) in first line
| Study group | Role | What they receive |
|---|---|---|
| ADK | All adult patients diagnosed with pancreatic cancer at AP-HP hospitals, identified using ICD-10 codes (C25) Receives: Drug: Patients treated with FOLFOX or FOLFIRINOX in first line; Drug: Patients treated with GEMCITABINE in first line |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival after diagnosis of pancreatic cancer
Overall survival will be assessed using mortality data recorded in the AP-HP Clinical Data Warehouse. The objective is to evaluate prognosis and identify risk factors associated with death after a diagnosis of pancreatic cancer, by integrating clinical, biological, histological and radiomics information. Survival will be analysed at multiple time points, including 1 month, 6 months, and 1 year after diagnosis.
Measured: From diagnosis up to 7 years after
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2025
- Study start9 Jan 2024
- Primary completionDec 2025 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Anna PELLAT, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07243288
- Sponsor's protocol ID
- DAT23014
- Acronym
- RADIOPAN
- Status last verified
- Oct 2025
- First submitted
- 17 Nov 2025
- Last updated
- 21 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018 Nov;68(6):394-424. doi: 10.3322/caac.21492. Epub 2018 Sep 12.
PubMed 30207593Conroy T, Desseigne F, Ychou M, Bouche O, Guimbaud R, Becouarn Y, Adenis A, Raoul JL, Gourgou-Bourgade S, de la Fouchardiere C, Bennouna J, Bachet JB, Khemissa-Akouz F, Pere-Verge D, Delbaldo C, Assenat E, Chauffert B, Michel P, Montoto-Grillot C, Ducreux M; Groupe Tumeurs Digestives of Unicancer; PRODIGE Intergroup. FOLFIRINOX versus gemcitabine for metastatic pancreatic cancer. N Engl J Med. 2011 May 12;364(19):1817-25. doi: 10.1056/NEJMoa1011923.
PubMed 21561347Bartoli M, Barat M, Dohan A, Gaujoux S, Coriat R, Hoeffel C, Cassinotto C, Chassagnon G, Soyer P. CT and MRI of pancreatic tumors: an update in the era of radiomics. Jpn J Radiol. 2020 Dec;38(12):1111-1124. doi: 10.1007/s11604-020-01057-6. Epub 2020 Oct 21.
PubMed 33085029Cheng SH, Cheng YJ, Jin ZY, Xue HD. Unresectable pancreatic ductal adenocarcinoma: Role of CT quantitative imaging biomarkers for predicting outcomes of patients treated with chemotherapy. Eur J Radiol. 2019 Apr;113:188-197. doi: 10.1016/j.ejrad.2019.02.009. Epub 2019 Feb 11.
PubMed 30927946
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of an Early Radiomic Signature in Patients With Metastatic Pancreatic Adenocarcinoma Treated With First-line Chemotherapy
- ClinicalTrials.gov ID
- NCT07243288
- Acronym / sponsor ID
- RADIOPAN / DAT23014
- Keywords
- Pancreatic cancer, Radiomics, RWE epidemiology, Prognosis prediction
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- 9 Jan 2024 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 21 Nov 2025 (actual)
- 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.
Pancreatic cancer, which has a poor prognosis, is becoming increasingly common in industrialized countries. Chemotherapy is the main treatment available for metastatic disease. Response to chemotherapy is currently assessed using imaging to monitor changes in the size of lesions undergoing treatment. Radiomics is a new method of analyzing quantitative data extracted from imaging that can be used to develop prediction algorithms and evaluate response to treatment. There is little robust radiomics data available for evaluating response to first-line treatments for pancreatic adenocarcinoma. Our main hypothesis is that quantifying tumor-related architectural changes could enable early identification of patients who will not respond to chemotherapy.
Detailed description
Pancreatic adenocarcinoma is a cancer with a poor prognosis, and its incidence is increasing, particularly in industrialized countries. Systemic chemotherapy, the main treatment available, has improved survival in patients with metastatic pancreatic adenocarcinoma. Following the results of the study by Conroy et al., the combination of 5FU + oxaliplatin + irinotecan (FOLFIRINOX) is one of the standard first-line chemotherapy regimens for metastatic pancreatic adenocarcinoma.
The population of patients with metastatic pancreatic adenocarcinoma is heterogeneous, with different survival profiles. This is part of a multifactorial picture that is still poorly understood (molecular, terrain, other factors, etc.). Response to chemotherapy is currently assessed using the RECIST 1.1 method, which takes into account changes in the size of lesions during treatment. However, this method is sometimes limited, as it does not always take into account the underlying pathophysiology.
Radiomics consists of analyzing quantitative data extracted from imaging, which allows prediction algorithms to be developed. Several studies have suggested that tumor architecture could be a biomarker of response and survival in patients with esophageal, lung, or colorectal cancer.
A study of 41 patients with advanced pancreatic cancer treated with gemcitabine-based chemotherapy evaluated the impact of radiological architectural assessment on treatment response. The results showed that tumor size, asymmetry, and standard deviation of density at baseline were associated with progression-free survival, and that tumor size and standard deviation of density at baseline were associated with overall survival. These results remain to be confirmed in a larger population, hence the value of conducting our work with data from our database.
Our main hypothesis is that quantifying tumor-related architectural changes could enable early identification of patients who will not respond to treatment. The overall objective would be to tailor the therapeutic strategy to each individual patient.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ADK | – | Drug: Patients treated with FOLFOX or FOLFIRINOX in first line, Drug: Patients treated with GEMCITABINE in first lineAll adult patients diagnosed with pancreatic cancer at AP-HP hospitals, identified using ICD-10 codes (C25) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with pancreatic cancer across all AP-HP hospitals. Data will be collected retrospectively from the AP-HP Clinical Data Warehouse (EDS).
Key inclusion criteria (2 listed)
- Adult patients (≥18 years)
- Diagnosis of acute alcoholic hepatitis (ICD10 C25) in a pathology report, followed by manual verification in clinical documents
Key exclusion criteria (1 listed)
- Patients younger than 18 years at diagnosis
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 |
|---|---|---|
| Patients treated with FOLFOX or FOLFIRINOX in first lineTreatment with FOLFOX or FOLFIRINOX (chemotherapy protocols) in first line | Drug | ADK |
| Patients treated with GEMCITABINE in first lineTreatment with GEMCITABINE (chemotherapy protocols) in first line | Drug | ADK |
Primary outcome
Overall survival after diagnosis of pancreatic cancer
Time frame: From diagnosis up to 7 years after
Overall survival will be assessed using mortality data recorded in the AP-HP Clinical Data Warehouse. The objective is to evaluate prognosis and identify risk factors associated with death after a diagnosis of pancreatic cancer, by integrating clinical, biological, histological and radiomics information. Survival will be analysed at multiple time points, including 1 month, 6 months, and 1 year after diagnosis.
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 21 Nov 2025.
- Background: PubMed 30207593Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018 Nov;68(6):394-424. doi: 10.3322/caac.21492. Epub 2018 Sep 12.
- Background: PubMed 21561347Conroy T, Desseigne F, Ychou M, Bouche O, Guimbaud R, Becouarn Y, Adenis A, Raoul JL, Gourgou-Bourgade S, de la Fouchardiere C, Bennouna J, Bachet JB, Khemissa-Akouz F, Pere-Verge D, Delbaldo C, Assenat E, Chauffert B, Michel P, Montoto-Grillot C, Ducreux M; Groupe Tumeurs Digestives of Unicancer; PRODIGE Intergroup. FOLFIRINOX versus gemcitabine for metastatic pancreatic cancer. N Engl J Med. 2011 May 12;364(19):1817-25. doi: 10.1056/NEJMoa1011923.
- Background: PubMed 33085029Bartoli M, Barat M, Dohan A, Gaujoux S, Coriat R, Hoeffel C, Cassinotto C, Chassagnon G, Soyer P. CT and MRI of pancreatic tumors: an update in the era of radiomics. Jpn J Radiol. 2020 Dec;38(12):1111-1124. doi: 10.1007/s11604-020-01057-6. Epub 2020 Oct 21.
- Background: PubMed 30927946Cheng SH, Cheng YJ, Jin ZY, Xue HD. Unresectable pancreatic ductal adenocarcinoma: Role of CT quantitative imaging biomarkers for predicting outcomes of patients treated with chemotherapy. Eur J Radiol. 2019 Apr;113:188-197. doi: 10.1016/j.ejrad.2019.02.009. Epub 2019 Feb 11.
- Individual participant dataSharing planned: No
Related trials for Pancreatic Cancer
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.
Anna PELLAT principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreatic Cancer and MeSH Term-Pancreatic Cancer, Adult), run by Assistance Publique - Hôpitaux de Paris at 1 site 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 2 inclusion and 1 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 21 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Overall survival after diagnosis of pancreatic cancer (time frame: From diagnosis up to 7 years after). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07243288, which also lists 4 linked publications.
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 21 Nov 2025.