Locally Advanced Pancreatic AdenocarcinomaPhase 2RAIPANCNCT07097064
Evaluation of the Stereotactic MR-guided Adaptive Radiotherapy for Locally Advanced Pancreatic Cancers
A Phase 2 study testing standard radiotherapy with chemotherapy and MRI-guided adaptive stereotactic radiotherapy (SMART) in people with Locally Advanced Pancreatic Adenocarcinoma, run by Institut du Cancer de Montpellier - Val d'Aurelle at 17 sites in France.
Trial summary
Pancreatic cancer is on the rise, and is set to become the 2nd leading cause of cancer deaths by 2030. Its prognosis is very poor, with a 5-year survival rate of just 5.5%. Curative surgery with chemotherapy improves survival, but only 20% of patients are eligible. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Locally Advanced Pancreatic Adenocarcinoma
- What is being tested?
- standard radiotherapy with chemotherapy and MRI-guided adaptive stereotactic radiotherapy (SMART)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 17 sitesFrance
- Study dates
- Sep 2025to Sep 2033
- Phase
- Phase 2
- 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
- Histologically proven pancreatic adenocarcinoma ;
- Age ≥ 18 years ;
- WHO score 0-1 ;
- Locally advanced according to NCCN 1.2015 recommendations;
- Non-metastatic after TAP scan and MRI of the liver ;
- CA 19.9 < 1000 IU/mL ;
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- Completion of at least 4 cycles of induction chemotherapy (Folfirinox and/or Gemzar-Abraxane) with a maximum of 8 courses ;
- Women of childbearing potential must have a pregnancy blood test within a maximum of 7 days before starting the study treatment. A negative result must be documented before study treatment is started. Women without reproductive potential are postmenopausal women or women who have undergone permanent sterilisation (e.g. tubal occlusion, hysterectomy, bilateral salpingectomy) ;
- Effective contraception for women of childbearing age ;
- Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests and other study procedures ;
- Patient has given informed, written and express consent ;
- Patient affiliated to a French health insurance scheme.
Who cannot join
- Other concomitant cancer or history of cancer, with the exception of treated cervical cancer in situ, basal or squamous cell skin carcinoma, superficial bladder tumour (Ta, Tis, and T1) or a tumour with a good prognosis treated curatively without chemotherapy and without evidence of disease in the 3 years prior to inclusion ;
- History of radiotherapy with a foreseeable overlap with the radiotherapy treatment under study (history of abdominal irradiation) ;
- Contraindication to MRI and MRI-guided radiotherapy (claustrophobia, presence of metallic elements etc...) ;
- History of chronic inflammatory disease of the colon or rectum ;
- Women who are pregnant, parturient or breastfeeding ;
- Any other serious concomitant and unbalanced disease or disorder that may interfere with the patient's participation in the study and his/her safety during the study (e.g. severe hepatic, renal, pulmonary, metabolic, or psychiatric disorders) ;
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- Legal incapacity (patient under curatorship or guardianship) ;
- History of severe and unexpected reactions to treatment containing a fluoropyrimidine ;
- Hypersensitivity to capecitabine, to used excipients or to fluorouracil ;
- Known complete deficiency of dihydropyrimidine dehydrogenase (DPD) ;
- In patients with severe leukopenia, neutropenia or thrombocytopenia ;
- In patients with severe hepatic insufficiency ;
- Patients with severe renal insufficiency (creatinine clearance less than 30 mL/min) ;
- Recent or concomitant treatment with brivudine.
Trial locations and contacts
17 sites in 1 country. Contact the study team or a site near you to ask about taking part.
17 sites in 1 country
France17 sites
Centre d'Oncologie du Pays-Basque
Bayonne, 64100
Angélique DUCTEIL, MD, angelique.ducteil@copb.eu
Institut Bergonié
Bordeaux, 33076
Paul SARGOS, MD, p.sargos@bordeaux.unicancer.fr
CHU Brest
Brest, 29200
Vincent BOURBONNE, MD, vincent.bourbonne@chu-brest.fr
Centre Hospitalier Carcassone
Carcassonne, 11010
Samir HACENE, MD, samir.hacene@ch-carcassonne.fr
Centre Jean PERRIN
Clermont-Ferrand, 63011
Geneviève LOOS, MD, genevieve.loos@clermont.unicancer.fr
Centre Georges François Leclerc
Dijon, 21079
Magali ROUFFIAC, MD, mrouffiac@cgfl.fr
Centre Oscar Lambret
Lille, 59000
David PASQUIER, MD, d-pasquier@o-lambret.fr
Institut Paoli-Calmettes
Marseille, 13009
Agnès TALLET-RICHARD, MD, talleta@ipc.unicancer.fr
Institut régional du Cancer de Montpellier
Montpellier, 34298
Morgan MICHALET, MD, +33467618584, Morgan.Michalet@icm.unicancer.fr
Morgan MICHALET, MD
CHU Nîmes
Nîmes, 30029
David AZRIA, MD, david.azria@chu-nimes.fr
Hôpital européen Georges-Pompidou
Paris, 75015
Jean-Emmanuel BIBAULT, MD, jebibault@gmail.com
Emmanuelle FABIANO, MD, Emmanuelle.fabiano@aphp.fr
Hôpital Tenon AP-HP
Paris, 75020
Florence HUGUET, MD, florence.huguet@aphp.fr
HU Pitié-Salpêtrière
Paris, 75651
Jean-Marc SIMON, MD, jean-marc.simon@aphp.fr
CHU Bordeaux Haut-Lévêque
Pessac, 33604
Véronique VENDRELY, MD, veronique.vendrely@chu-bordeaux.fr
Centre Eugène Marquis
Rennes, 35042
Ingrid MASSON, MD, i.masson@rennes.unicancer.fr
Institut Claudius Regaud
Toulouse, 31059
Audrey KELLER, MD, Keller.audrey@iuct-oncopole.fr
ORLAM
Villeurbanne, 69100
Victor PASSERAT, MD, victor.passerat@gmail.com
About this study
Pancreatic cancer is on the rise, and is set to become the 2nd leading cause of cancer deaths by 2030. Its prognosis is very poor, with a 5-year survival rate of just 5.5%. Curative surgery with chemotherapy improves survival, but only 20% of patients are eligible. For locally advanced forms, radiotherapy, notably in the form of MRI-guided adaptive stereotactic radiotherapy (SMART), is showing promising results in terms of survival and local control, but still requires prospective validation.
Read the detailed description
In 2016, pancreatic cancer became the 3rd leading cause of cancer death worldwide, and could be the 2nd by 2030. Its prognosis remains very unfavorable, with a 5-year overall survival rate of 5.5%, all stages combined. In France, incidence is on the rise, with 14,100 new cases and 11,400 deaths in 2018. The only therapeutic strategy that has shown a significant improvement in survival is curative surgery followed by adjuvant chemotherapy, but only 20% of patients are eligible. The majority of cases are diagnosed at an advanced or unresectable stage.
For locally advanced cancers (LACC), management is not standardized. Two induction chemotherapy regimens have been validated: FOLFIRINOX and GEMBRAX. The role of radiochemotherapy remains debated. The LAP07 study showed no significant benefit of radiochemotherapy on overall survival, although it did improve progression-free survival and locoregional control.
New techniques such as MRI-guided adaptive stereotactic radiotherapy (SMART) enable more targeted and intense delivery of radiation dose, while protecting organs at risk. Retrospective studies have shown a significant improvement in local control (up to 98% at 1 year) and overall survival (up to 23 months) with this method, compared with conventional radiotherapy. However, prospective studies are still needed to confirm the value of SMART in the management of locally advanced pancreatic cancer.
- Being tested
- standard radiotherapy with chemotherapy, MRI-guided adaptive stereotactic radiotherapy (SMART)
- Keywords
- Pancreatic Adenocarcinoma, adaptative radiotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
standard radiotherapy with chemotherapyCombination product
intensity-modulated conformal radiotherapy (IMRT) 50-54 Gy in 25-30 fractions with concomitant Xeloda 800-825 mg/m2 morning and evening 5d/7.
MRI-guided adaptive stereotactic radiotherapy (SMART)Radiation
MRI-guided adaptive stereotactic radiotherapy (SMART) 50 Gy / 5 fractions without concomitant chemotherapy.
| Study group | Role | What they receive |
|---|---|---|
| Standard cohort | Active comparator | intensity-modulated conformal radiotherapy (IMRT) 50-54 Gy in 25-30 fractions with concomitant Xeloda 800-825 mg/m2 morning and evening 5 days a week (standard of care according to RECORAD and TNCD). Receives: Combination Product: standard radiotherapy with chemotherapy |
| Experimental cohort | Experimental | MRI-guided adaptive stereotactic radiotherapy (extreme hypofractionation) (SMART) 50Gy/ 5 fractions without concomitant chemotherapy. Receives: Radiation: MRI-guided adaptive stereotactic radiotherapy (SMART) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of local control at 1 year by 20% in the experimental cohort compared with the standard cohort.
Local control rate, assessed by TAP scan according to RECIST 1.1 criteria (Appendix 8) +/- oesogastroduodenal fibroscopy (FOGD) in case of upper digestive symptomatology not explained by CT scan.
The local control rate is defined as the proportion of patients without local progression, the time to local progression being defined as the time between the start date of radiotherapy and the date of documented local progression. Patients will be censored at date of death if they die of a carcinological outcome other than local recurrence, or of another cause. Patients without local progression will be censored at the date of last follow-up.
Measured: From enrollment to one year after treatment completion
Secondary outcomes (9)
Evaluation of Overall Survival
Overall survival (OS) at 1 year, with overall survival defined as the time between the date of starting RT treatment and the date of death from any cause ;
Measured: 1 year after enrollment
Evaluation of progression-free survival
Progression-free survival (PFS) at 1 year, progression-free survival defined as the time between the date of starting RT treatment and the date of 1st documented progression or the date of death from any cause ; Progression will be assessed by TAP, or OGD if suspicion of local recurrence not identified on the scanner (same imaging technique for all patients) ;
Measured: 1 year after enrollment
Evaluation of Metastasis-free survival
Metastasis-free survival (MFS) at 1 year, with MFS defined as the time from the start date of RT treatment to the date of first metastatic progression; Metastatic progression will be assessed using CT-scan
Measured: 1 year after enrollment
Evaluation of severe acute gastrointestinal toxicity
Rate of intestinal and gastric toxicity grade > 2 during and in the 90 days following the end of radiotherapy, evaluated according to the CTCAE v5.0 classification
Measured: 90 days after the end of radiotherapy
Evaluation of safety (acute and late toxicities of RT)
Acute and late toxicities evaluated according to the CTCAE v5.0 classification :
- Acute toxicity is defined as toxicity observed between the start of RT and up to 3 months after the end of RT.
- Late toxicity is defined as toxicity observed between 3 months and 5 years after the end of radiotherapy.
- Late toxicity will be evaluated at 3 and 5 years.
Measured: Up to 5 years after treatment
Quality of life evaluation
Quality of life evaluated by the EORTC QLQ-C30 questionnaire at each consultation (initial, end of radiotherapy, and at each follow-up (every 3 months after treatment)
Measured: Up to 5 years after treatment
Evaluation of the evolution of the tumour marker CA 19.9
Change in tumour marker CA 19.9 from baseline to follow-up
Measured: Until the end of the follow-up
Dosimetric benefits of daily adaptation, for each dosimetric parameter (GTV and PTV coverage, organs at risk doses), by comparing the average results obtained for each patient over all sessions with the 'adapted' plan compared to the 'predicted plan'
Collection of the dosimetric results obtained in terms of dose/volume on the projected dosimetry (coverage of the PTV by the prescription dose on the total dosimetry, dose received at GTV....) ; Collection and summation of dosimetric results obtained in terms of dose/volume for adaptive radiotherapy sessions and comparison with predictive dosimetry
Measured: At the end of the treatment
Correlation between dosimetry and outcomes (local control, toxicities)
Correlation of PTV coverage and GTV dose with local control, progression-free survival and overall survival (predictive and adaptive dosimetry) ; Correlation of the dose received in organs at risk (duodenum, small intestine, stomach, colon) with the occurrence of acute and late digestive toxicities (predictive and adaptive dosimetry)
Measured: At the end of the treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2025
- Study startSep 2025 (estimated)
- Primary completionSep 2028 (estimated)
- Study completionSep 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced Pancreatic AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by Institut du Cancer de Montpellier - Val d'AurelleThe 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07097064
- Sponsor's protocol ID
- PROICM 2024-06 RAI
- Acronym
- RAIPANC
- Status last verified
- Jul 2025
- First submitted
- 17 Jul 2025
- Last updated
- 31 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Stereotactic MR-guided Adaptive Radiotherapy for Locally Advanced Pancreatic Cancers
- ClinicalTrials.gov ID
- NCT07097064
- Acronym / sponsor ID
- RAIPANC / PROICM 2024-06 RAI
- Keywords
- Pancreatic Adenocarcinoma, adaptative radiotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Institut du Cancer de Montpellier - Val d'AurelleUniversity, hospital or other
- Study start
- Sep 2025 (estimated)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Sep 2033 (estimated)
- First posted
- 31 Jul 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 is on the rise, and is set to become the 2nd leading cause of cancer deaths by 2030. Its prognosis is very poor, with a 5-year survival rate of just 5.5%. Curative surgery with chemotherapy improves survival, but only 20% of patients are eligible. For locally advanced forms, radiotherapy, notably in the form of MRI-guided adaptive stereotactic radiotherapy (SMART), is showing promising results in terms of survival and local control, but still requires prospective validation.
Detailed description
In 2016, pancreatic cancer became the 3rd leading cause of cancer death worldwide, and could be the 2nd by 2030. Its prognosis remains very unfavorable, with a 5-year overall survival rate of 5.5%, all stages combined. In France, incidence is on the rise, with 14,100 new cases and 11,400 deaths in 2018. The only therapeutic strategy that has shown a significant improvement in survival is curative surgery followed by adjuvant chemotherapy, but only 20% of patients are eligible. The majority of cases are diagnosed at an advanced or unresectable stage.
For locally advanced cancers (LACC), management is not standardized. Two induction chemotherapy regimens have been validated: FOLFIRINOX and GEMBRAX. The role of radiochemotherapy remains debated. The LAP07 study showed no significant benefit of radiochemotherapy on overall survival, although it did improve progression-free survival and locoregional control.
New techniques such as MRI-guided adaptive stereotactic radiotherapy (SMART) enable more targeted and intense delivery of radiation dose, while protecting organs at risk. Retrospective studies have shown a significant improvement in local control (up to 98% at 1 year) and overall survival (up to 23 months) with this method, compared with conventional radiotherapy. However, prospective studies are still needed to confirm the value of SMART in the management of locally advanced pancreatic cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard cohort | Active comparator | Combination Product: standard radiotherapy with chemotherapyintensity-modulated conformal radiotherapy (IMRT) 50-54 Gy in 25-30 fractions with concomitant Xeloda 800-825 mg/m2 morning and evening 5 days a week (standard of care according to RECORAD and TNCD). |
| Experimental cohort | Experimental | Radiation: MRI-guided adaptive stereotactic radiotherapy (SMART)MRI-guided adaptive stereotactic radiotherapy (extreme hypofractionation) (SMART) 50Gy/ 5 fractions without concomitant chemotherapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Histologically proven pancreatic adenocarcinoma ;
- Age ≥ 18 years ;
- WHO score 0-1 ;
- Locally advanced according to NCCN 1.2015 recommendations;
- Non-metastatic after TAP scan and MRI of the liver ;
Key exclusion criteria (14 listed)
- Other concomitant cancer or history of cancer, with the exception of treated cervical cancer in situ, basal or squamous cell skin carcinoma, superficial bladder tumour (Ta, Tis, and T1) or a tumour with a good prognosis treated curatively without chemotherapy and without evidence of disease in the 3 years prior to inclusion ;
- History of radiotherapy with a foreseeable overlap with the radiotherapy treatment under study (history of abdominal irradiation) ;
- Contraindication to MRI and MRI-guided radiotherapy (claustrophobia, presence of metallic elements etc...) ;
- History of chronic inflammatory disease of the colon or rectum ;
- Women who are pregnant, parturient or breastfeeding ;
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 |
|---|---|---|
| standard radiotherapy with chemotherapyintensity-modulated conformal radiotherapy (IMRT) 50-54 Gy in 25-30 fractions with concomitant Xeloda 800-825 mg/m2 morning and evening 5d/7. | Combination product | Standard cohort |
| MRI-guided adaptive stereotactic radiotherapy (SMART)MRI-guided adaptive stereotactic radiotherapy (SMART) 50 Gy / 5 fractions without concomitant chemotherapy. | Radiation | Experimental cohort |
Primary outcome
Improvement of local control at 1 year by 20% in the experimental cohort compared with the standard cohort.
Time frame: From enrollment to one year after treatment completion
Local control rate, assessed by TAP scan according to RECIST 1.1 criteria (Appendix 8) +/- oesogastroduodenal fibroscopy (FOGD) in case of upper digestive symptomatology not explained by CT scan. The local control rate is defined as the proportion of patients without local progression, the time to local progression being defined as the time between the start date of radiotherapy and the date of documented local progression. Patients will be censored at date of death if they die of a carcinological outcome other than local recurrence, or of another cause. Patients without local progression will be censored at the date of last follow-up.
9 secondary outcomes
Evaluation of Overall Survival
Time frame: 1 year after enrollment
Evaluation of progression-free survival
Time frame: 1 year after enrollment
Evaluation of Metastasis-free survival
Time frame: 1 year after enrollment
Evaluation of severe acute gastrointestinal toxicity
Time frame: 90 days after the end of radiotherapy
Evaluation of safety (acute and late toxicities of RT)
Time frame: Up to 5 years after treatment
Quality of life evaluation
Time frame: Up to 5 years after treatment
Evaluation of the evolution of the tumour marker CA 19.9
Time frame: Until the end of the follow-up
Dosimetric benefits of daily adaptation, for each dosimetric parameter (GTV and PTV coverage, organs at risk doses), by comparing the average results obtained for each patient over all sessions with the 'adapted' plan compared to the 'predicted plan'
Time frame: At the end of the treatment
Correlation between dosimetry and outcomes (local control, toxicities)
Time frame: At the end of the treatment
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 31 Jul 2025.
- Individual participant dataSharing planned: No
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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.
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing standard radiotherapy with chemotherapy and MRI-guided adaptive stereotactic radiotherapy (SMART) in people with Locally Advanced Pancreatic Adenocarcinoma, run by Institut du Cancer de Montpellier - Val d'Aurelle at 17 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 12 inclusion and 14 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: opening soon, as of the sponsor's last update on 31 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Aurore MOUSSION (+33467613102, drci-soumissions@icm.unicancer.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement of local control at 1 year by 20% in the experimental cohort compared with the standard cohort. (time frame: From enrollment to one year after treatment completion). 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 31 Jul 2025.