Locally Advanced Pancreatic AdenocarcinomaPhase 2GABRINOX-ARTNCT04570943
Sequential Treatment With GEMBRAX and Then FOLFIRINOX Followed by Stereotactic MRI-guided Radiotherapy in Patients With Locally Advanced Pancreatic Cancer
A Phase 2 study testing Gabrinox and MRI-GUIDED STEREOTACTIC RADIOTHERAPY in people with Locally Advanced Pancreatic Adenocarcinoma, run by Institut du Cancer de Montpellier - Val d'Aurelle at 9 sites in France.
Trial summary
The aim of this study is to demonstrate the efficacy of intensified and sequential chemotherapy (Gabrinox) comprising Gembrax regimen (Gemcitabine-Abraxane) followed by the Folfirinox regimen (5FU, Oxaliplatin and Irinotecan) in patients with locally advanced pancreatic adenocarcinoma. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Locally Advanced Pancreatic Adenocarcinoma
- What is being tested?
- Gabrinox and MRI-GUIDED STEREOTACTIC RADIOTHERAPY
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 103 participants
- Where
- 9 sitesFrance
- Study dates
- 16 Jun 2021to Jun 2030
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient aged from 18 to 75 years at the date of signature of the consent form
- Histologically or cytologically proven pancreatic adenocarcinoma
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1
- Non-resectable tumour according to the National Comprehensive Cancer Network (NCCN) 1.2015 recommendations after external review of imaging data by multidisciplinary experts.
- Non-metastatic cancer confirmed by thorax-abdomen-pelvis computerized tomography (CT) scan and liver MRI
- SMART feasibility confirmed by centralized review
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- Uracilemia < 16 ng/ml
- Hematological assessment within 14 days before inclusion, defined by:
- Neutrophils ≥ 2 000/mm3 (2 × 109/L);
- Platelets ≥ 100 000/mm3 (100 × 109/L);
- Hemoglobin ≥ 9 g/dl
- Liver function (within 14 days before inclusion) defined by:
- ASpartate Transaminase (AST) and ALanine Transaminase (ALT) ≤ 2.5 x Upper Limit of Normal (ULN);
- Total bilirubin ≤ 1.5 x ULN. Patients with a metallic biliary prosthesis due to biliary obstruction caused by the cancer may be included, if: a CT scan with injection of contrast medium and thin pancreas sections was performed before placing the biliary prosthesis, the bilirubin level after prosthesis fitting decreased to ≤20 mg/L (≤34 μmol/L), and in the absence of cholangitis.
- Creatininaemia within the reference limits, or calculated clearance ≥50 ml/min for patients with a serum creatinine value above or below the reference values (clearance calculated using the Chronic Kidney Disease EPIdemiology collaboration (CKDEPI formula).
- Serum calcium AND magnesium AND potassium ≥ Lower Limit Normal (LLN and ≤ 1.2 x Upper Limit Normal (ULN)
- Cancer Antigen (CA 19.9) <500 IU/mL (without cholestasis). Patients with CA 19.9 between 500 IU/mL and 1000 IU/mL can be included if the Positron Emission Tomography (PET) scan and peritoneal MRI (optional) do not detect any distant fixation, indicative of metastasis. Patients with CA 19.9 ≥ 1000 IU/mL cannot be included.
- Sexually active patients must use a contraceptive method considered adequate and suitable by the investigator during the entire period of administration of the study treatment and up to 6 months after the treatment end, for female and male patients.
- Signature of the consent form before any study-specific procedure.
- Covered by the French health insurance.
Who cannot join
- Any previous treatment for pancreatic cancer (e.g. chemotherapy, radiotherapy, surgery, targeted therapy, experimental therapy)
- Gilbert's syndrome or homozygous Uridine DiPhosphate Glucuronosyl Transferase 1 A1 (UGT1A1 * 28)
- Other concomitant cancer or history of cancer, except for treated in situ cancer of the cervix , basal cell or squamous cell carcinoma, superficial bladder tumour (Ta, Tis, and T1), or good-prognosis tumour cured without chemotherapy and without signs of disease in the 3 years before inclusion
- Prior radiotherapy likely to overlap with the planned study radiotherapy area (e.g. previous abdominal irradiation).
- Patients with high cardiovascular risk, including, but not limited to, coronary stent or myocardial infarction in the past 6 months.
- Peripheral neuropathy ≥ grade 2
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- ECG with QTcorrected (QTc) interval longer than 450 ms for men and longer than 470 ms for women
- Contraindication to MRI and MRI-guided radiotherapy
- History of chronic inflammatory disease of the colon or rectum
- Any other concomitant and not controlled serious illness or disturbance that may interfere with the patient's participation in the study and safety during the study (e.g. severe liver, kidney, lung, metabolic, or psychiatric disorder)
- Intolerance or allergy to one of the study drugs (gemcitabine, Nab-paclitaxel, oxaliplatin, irinotecan, 5-FU) or to one of their excipients (e.g. fructose) listed in the Contraindications or Warnings sections and Special precautions of the Summary of Product Characteristics (SmPC) or prescription information
- Legal incapacity (patient under guardianship or wardship)
- Pregnant or breastfeeding woman. Fertile women must have a negative pregnancy test (serum β-hCG) performed 72 hours before inclusion
- Patient using vitamin K antagonists (Coumadin…) (possible modification of the treatment before inclusion)
- Active and uncontrolled bacterial or fungal infection that requires systemic treatment.
- Know active HIV infection
- History of peripheral arterial disease (e.g. lameness, Buerger's disease).
- Patient who received a attenuated live vaccine in the 10 days before inclusion
- Patient with history of pulmonary fibrosis or interstitial pneumonia.
- Inability to attend the follow-up visits due to geographic, social or mental reasons.
- Participation in another clinical study with a research product during the last 30 days before inclusion.
Trial locations and contacts
9 sites in 1 country. Contact the study team or a site near you to ask about taking part.
9 sites in 1 country
France9 sites, 9 recruiting
- Not yet recruiting
Hôpital Beaujon
Clichy
Anne Laure MD VEDIE, +330140875728, annelaure.vedie@aphp.fr
Anne Laure MD VEDIE
- Recruiting
Centre Georges-François Leclerc
Dijon, 21079
François MD Ghiringhelli, MD, FGhiringhelli@cgfl.fr
François MD Ghiringhelli
- Recruiting
Institut Paoli Calmettes
Marseille, Bouches-du-Rhône, 13009
Jean Emmanuel MITRY, MD, MITRYJE@ipc.unicancer.fr
Jean Emmanuel MD MITRY
- Recruiting
CHU Saint-Eloi
Montpellier, Herault, 34295
Eric Assénat, MD, 04 67 33 67 33 ext. +33, e-assenat@chu-montpellier.fr
Eric md ASSENAT
- Recruiting
Institut régional du Cancer de Montpellier
Montpellier, Hérault, 34298
Fabienne Portalès, MD, 0467612353 ext. +33, fabienne.portales@icm.unicancer.fr
- Recruiting
CHU Carémeau
Nîmes, Gard, 30029
Stéphane Obled, MD, stephane.OBLED@chu-nimes.fr
- Recruiting
Hôpital Pitié Salpétriêre
Paris, 75013
Jean-Baptiste Bachet, MD, jean-baptiste.bachet@aphp.fr
Jean-Baptiste MD BACHET
- Not yet recruiting
Centre Eugène Marquis
Rennes, 35042
Ingrid MD MASSON, +33299253092, i.masson@rennes.unicancer.fr
Ingrid MD MASSON
- Not yet recruiting
Hopital Paul Brousse
Villejuif
Pascal MD HAMMEL, +33 1 45 59 36 30, pascal.hammel@aphp.fr
Pascal MD HAMMEL
About this study
Official title: Phase II Study to Assess the Interest of a Sequential Treatment With Gemcitabine/Nab-paclitaxel (GEMBRAX) and Then FOLFIRINOX Followed by Stereotactic Magnetic Resonance-guided Adaptive Radiotherapy in Patients With Locally Advanced Pancreatic Cancer
The aim of this study is to demonstrate the efficacy of intensified and sequential chemotherapy (Gabrinox) comprising Gembrax regimen (Gemcitabine-Abraxane) followed by the Folfirinox regimen (5FU, Oxaliplatin and Irinotecan) in patients with locally advanced pancreatic adenocarcinoma.
The study will also demonstrate the feasibility of combining this intensified chemotherapy with MRI-guided stereotactic radiotherapy in non-progressive patients after the chemotherapy by Gabrinox regimen.
Read the detailed description
Pancreatic cancer was the third cause of death by cancer worldwide in 2016, surpassing breast cancer. It is estimated that in 2030, pancreatic cancer will become the second cause of death by cancer after lung cancer.
Its prognosis is very poor, with an overall survival (OS) at 5 years, all stages included, of 5.5%. According to the French cancer registry network (FRANCIM), its incidence has more than doubled in men and women between 1990 and 2018. The world standardized incidence rates for men and women were 5.2% and 2.7% in 1990 and 11% and 7% in 2018, respectively. This means a yearly annual increase of 2.7 for men and of 3.8 for women. The often late diagnosis, in 50% of cases at stage 4, and the limited treatment options explain the very low survival rate at 5 years.
Currently, only surgery associated with adjuvant chemotherapy for 6 months allows doubling this survival rate. However, this situation concerns only 20% of cases. Indeed, 50% of pancreatic cancers are discovered at stage 4, and in 30% of patients cancer is detected when not resectable and non-metastatic (i.e. borderline resectable or locally advanced). To make an unresectable cancer resectable is one of the therapeutic strategies under development. However, treatment of locally advanced pancreatic cancer (LAPC) is not standardized. Chemotherapy is a used strategy, but 30% of cases will progress to metastatic disease. Therefore, the need in LAPC to control not only the local disease but also micro-metastases has led to the development of combined strategies with chemotherapy and optimal radiotherapy.
For LAPC, chemotherapy is based on two drug combinations that are classically used for the first-line treatment of metastatic disease: FOLFIRINOX (FFX) (association of 5FU, Oxaliplatin and Irinotecan) and GEMBRAX (GA) (association of gemcitabine and nab-paclitaxel). Their association has been validated by phase 3 studies showing that compared with gemcitabine alone, they allow increasing the response rate by three times (30%), and almost doubling the median survival and progression-free survival, but with higher grade 3 hematologic and neurological toxicities.
FFX and GA have been assessed also in LAPC. Retrospective studies confirmed the high response rate, 30 to 80% according to the study, and a median survival of 9 to 30 months. Recently, two phase 2 studies, evaluated GA alone and GA followed by FFX, respectively, for LAPC, and confirmed the efficacy, with a response rate of 30% and a secondary resection rate of 15% and 30.6%, respectively. Moreover, in patients who underwent tumour resection after treatment, survival was longer than in those not operated (27.4 vs 14.2 months; Hazard Ratio (HZ) = 0.45; p = 0.0035). Overall Survival (OS) (n= 165 patients) was 17.2 months.
GABRINOX is a sequential treatment with GA and then FFX with the aim of limiting chemoresistance, decreasing toxicities and improving dose intensity.
The feasibility and tolerance of this approach as first-line treatment of metastatic disease were validated in a phase 1 study, and its efficacy in a phase 2 study in which the primary objective was reached: objective response rate of 64.9%, disease control rate of 84.2%, progression-free survival (PFS) of 10.5 months, and Overall Survival (OS) of 15.1 months. Its tolerance profile is favorable with lower percentages of patients with neutropenia (34.5%), febrile neutropenia (3.5%), and neurotoxicity (5.2%).
The role of chemo-radiotherapy for LAPC remains controversial. Many old studies showed the interest of this technique for the local and global control in patients with pancreatic cancer.
However, a phase 3 study compared the efficacy of chemo-radiotherapy versus chemotherapy alone in patients without disease progression after chemotherapy with a regimen that is currently considered not optimal (i.e. gemcitabine with/without erlotinib). Although OS (the main endpoint) did not improve in the chemo-radiotherapy arm compared with the chemotherapy arm, PFS was significantly increased in the chemo-radiotherapy arm with a longer period without treatment (6.1 vs 3.7 months, P = 0.02) and a lower percentage of patients with locoregional progression (32% vs 46%, P =0.03). This confirms that radiotherapy is an effective treatment in pancreatic adenocarcinoma, but that the current delivery modalities do not allow significantly improving the patient prognosis. Indeed, the study used 3D conformal radiotherapy with conventional doses and classical fractioning. Retrospective and phase 1 and 2 studies that used more optimized techniques and higher doses reported better local disease control, but without an important impact on survival. Moreover, some studies suggest significant toxicity, particularly in gastrointestinal organs. Intensity-modulated radiotherapy and integrated boost radiotherapy showed promising local control and survival results. This suggests an avenue for technological improvement and dose augmentation to improve patient prognosis.
Stereotactic magnetic resonance-guided adaptive radiotherapy is a new modality for dose delivery that exploits Magnetic Resonance Imaging (MRI)-guided linear accelerators to better target the treatment volume, while optimizing the protection of organs at risk. The tumour localization in the pancreas seems to be particularly suitable for the utilization of MRI-guided linear accelerators because the radiotherapy doses are limited in function of the gastrointestinal organ tolerance: duodenum, stomach, small intestine, colon. Recently, the results of a retrospective, multicentre study on irradiation of patients with LAPC using Magnetic Resonance Imaging (MRIdian® Linac™; Viewray. The study shows that survival was improved in patients who received an augmented irradiation dose. Specifically, the 2-year OS rate was 49% for patients who received a dose higher than 70 Gy and 30% for patients who received a lower equivalent dose. The study did not report significant toxicity in patients who received high-dose radiotherapy according to the optimized modalities with daily dosimetric adjustment and target monitoring at each radiotherapy session. These data suggest that dose intensification and the stereotactic magnetic resonance-guided adaptive radiotherapy technique improve radiotherapy results; however, prospective studies are needed to confirm these data.
Therefore, the phase 2 study GABRINOX-ART in which an intensified chemotherapy regimen (GABRINOX i.e GA followed by FFX) is followed by optimized adjusted radiotherapy (stereotactic magnetic resonance-guided adaptive radiotherapy) seems to be an interesting strategy to evaluate in locally advanced pancreatic cancer.
- Being tested
- Gabrinox, MRI-GUIDED STEREOTACTIC RADIOTHERAPY
- Keywords
- Pancreatic, cancer
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GabrinoxCombination product
Regimen: GEMBRAX
Other Names:
Albumin bound paclitaxel 125 mg/m² + Gemcitabine 1000 mg/m²
Regimen: FOLFIRINOX
Other Names:
Oxaliplatin 85 mg/m² + Leucovorin 200 mg/m² + Irinotecan 180 mg/m² + 5FU bolus 400mg/m² + 5FU continuous 2400 mg/m²
Gembrax + Folfirinox = GABRINOX
MRI-GUIDED STEREOTACTIC RADIOTHERAPYRadiation
Radiotherapy will start between 5 and 6 weeks after the last injection of chemotherapy (FOLFIRINOX regimen) in non-progressive patients after Gabrinox.
Stereotactic adaptive radiotherapy in five fractions: prescription dose in five fractions of 10 Gy/day on consecutive days. At least two sessions/week should be performed. An interval of at least 18 hours between fractions is recommended.
| Study group | Role | What they receive |
|---|---|---|
| Gabrinox followed by stereotactic radiotherapy | Experimental | Gembrax:
Albumin-bound paclitaxel followed by Gemcitabine Day 1,8,15 followed by 2 weeks of rest
Folfirinox:
Oxaliplatin, irinotecan, leucovorin, 5FU bolus and continuous Receives: Combination Product: Gabrinox; Radiation: MRI-GUIDED STEREOTACTIC RADIOTHERAPY |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of non-progression at 4 months
(Sequence 1 success = chemotherapy) according to the RECIST v1.1 criteria
Measured: 4 months
Acute gastrointestinal non-toxicity rate
Absence of toxicity of grade ≥3 related to radiotherapy within 90 days, evaluated using the NCI-CTCAE v5.0 classification (sequence 2 success = radiotherapy)
Measured: 90 days
Secondary outcomes (20)
Assessment of adverse events due to chemotherapy by using the NCI-CTCAE version 5.0 scale
Adverse events of chemotherapy evaluated using the NCI-CTCAE v5.0 classification
Measured: 36 months
Assessment of adverse events due to radiotherapy by using the NCI-CTCAE version 5.0
Adverse events of radiotherapy evaluated using the NCI-CTCAE v5.0 classification
Measured: 36 months
Collection of dosimetric results regarding dose/volume from the planned dosimetry, such as coverage of the planning targeted volume (PTV) by the prescription dose in the accumulated dose
End of radiotherapy
Measured: An average of 9 months after the beginning of treatment (chemotherapy then radiotherapy)
Collection of dosimetric results regarding dose/volume from the planned dosimetry, such as dose received by the gross total volume
End of radiotherapy
Measured: An average of 9 months after the beginning of treatment (chemotherapy then radiotherapy)
Collection and Summation of the dosimetric results in terms of dose/volume for the adaptive radiotherapy sessions and comparison with the predicted dosimetry
End of radiotherapy
Measured: An average of 9 months after the beginning of treatment (chemotherapy then radiotherapy)
Correlation of the dose received by organs at risk (duodenum, small intestine, stomach, colon) with the appearance of gastrointestinal toxicities
End of radiotherapy
Measured: An average of 9 months after the beginning of treatment (chemotherapy then radiotherapy)
Correlation of planning target volume (PTV) coverage and dose received by the gross tumor volume (GTV) with progression free survival
End of radiotherapy
Measured: An average of 9 months after the beginning of treatment (chemotherapy then radiotherapy)
Correlation of planning target volume (PTV) coverage and dose received by the gross tumor volume (GTV) with overall survival
End of radiotherapy
Measured: An average of 9 months after the beginning of treatment (chemotherapy then radiotherapy)
Progression-free Survival (PFS) of the radiotherapy
Between the radiotherapy start date and the date of the first documented progression or the date of death from any cause
Measured: Through study completion, an average of 68 months
Overall Survival (OS) of the radiotherapy
Interval between the radiotherapy start date and the date of death from any cause
Measured: Through study completion, an average of 72 months
Local disease control of the radiotherapy
Interval between the radiotherapy start date and the date of local progression of the disease
Measured: Through study completion, an average of 68 months
Progression-free Survival (PFS) of the whole treatement
Between the date of inclusion and the date of the first documented progression or the date of death from any cause
Measured: Through study completion, an average of 72 months
Overall Survival (OS) of the whole treatement
Interval between the date of inclusion and the date of death from any cause
Measured: Through study completion, an average of 72 months
Assessment of adverse events due to the whole treatement
Assessment of adverse events by using the NCI-CTCAE version 5.0 scale from inclusion of first patient until the end of treatment
Measured: Through study completion, an average of 36 months
Resection rate
Percentage of patients who undergo tumour surgery up to 6 months post-radiotherapy
Measured: From the end of radiotherapy (3 months) through 6 months post-radiotherapy
Healthy margin resection rate (R0)
Measured: From the end of radiotherapy (3 months) through 6 months post-radiotherapy
Histological response rate
Histological response rate according to the College of American Pathologists grading system.
Measured: From the end of radiotherapy (3 months) through 6 months post-radiotherapy
Prognostic impact of CA 19-9 changes on survival
Measured: Through study completion, an average of 36 months
Quality of life by using the quality of life questionnaire score (QLQ-C30)
The EORTC QLQ-C30 uses for the questions 1 to 28 a 4-point scale. The scale scores from 1 to 4: 1 ("Not at all"), 2 ("A little"), 3 ("Quite a bit") and 4 ("Very much"). Half points are not allowed. The range is 3. For the raw score, less points are considered to have a better outcome.
The EORTC QLQ-C30 uses for the questions 29 and 30 a 7-points scale. The scale scores from 1 to 7: 1 ("very poor") to 7 ("excellent"). Half points are not allowed. The range is 6. First of all, raw score has to be calculated with mean values. Afterwards linear transformation is performed to be comparable. More points are considered to have a better outcome.
Measured: Through study completion, an average of 60 months
Quality of life by using the quality of life questionnaire score (QLQ-PAN26)
The QLQ-PAN26 uses for the question 31 to 56 a 4-point scale. The scale scores from 1 to 4: 1 ("Not at all"), 2 ("A little"), 3 ("Quite a bit") and 4 ("Very much").
Measured: Through study completion, an average of 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2020
- Study start16 Jun 2021
- Primary completionJan 2028 (estimated)
- Study completionJun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (26)Papers the sponsor has linked to this study.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 103 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fabienne Portalès, MD, Study chair, Institut de Cancérologie de Montpellier (ICM)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04570943
- Sponsor's protocol ID
- PROICM 2020-04 GAB
- Acronym
- GABRINOX-ART
- Status last verified
- Apr 2025
- First submitted
- 24 Sep 2020
- Last updated
- 5 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All data will be available after publication of the results in peer-reviewed revues, and in national and international meetings. It includes all de-identified participants' data, the study protocol, the statistical analysis plan and the clinical study report. The corresponding author will provide data and datasets generated and/or analyzed during the study upon reasonable request.
Publications
Siegel RL, Miller KD, Jemal A. Cancer Statistics, 2017. CA Cancer J Clin. 2017 Jan;67(1):7-30. doi: 10.3322/caac.21387. Epub 2017 Jan 5.
PubMed 28055103Ferlay J, Partensky C, Bray F. More deaths from pancreatic cancer than breast cancer in the EU by 2017. Acta Oncol. 2016 Sep-Oct;55(9-10):1158-1160. doi: 10.1080/0284186X.2016.1197419. Epub 2016 Aug 23.
PubMed 27551890Conroy T, Hammel P, Hebbar M, Ben Abdelghani M, Wei AC, Raoul JL, Chone L, Francois E, Artru P, Biagi JJ, Lecomte T, Assenat E, Faroux R, Ychou M, Volet J, Sauvanet A, Breysacher G, Di Fiore F, Cripps C, Kavan P, Texereau P, Bouhier-Leporrier K, Khemissa-Akouz F, Legoux JL, Juzyna B, Gourgou S, O'Callaghan CJ, Jouffroy-Zeller C, Rat P, Malka D, Castan F, Bachet JB; Canadian Cancer Trials Group and the Unicancer-GI-PRODIGE Group. FOLFIRINOX or Gemcitabine as Adjuvant Therapy for Pancreatic Cancer. N Engl J Med. 2018 Dec 20;379(25):2395-2406. doi: 10.1056/NEJMoa1809775.
PubMed 30575490Conroy 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 21561347Von Hoff DD, Ervin T, Arena FP, Chiorean EG, Infante J, Moore M, Seay T, Tjulandin SA, Ma WW, Saleh MN, Harris M, Reni M, Dowden S, Laheru D, Bahary N, Ramanathan RK, Tabernero J, Hidalgo M, Goldstein D, Van Cutsem E, Wei X, Iglesias J, Renschler MF. Increased survival in pancreatic cancer with nab-paclitaxel plus gemcitabine. N Engl J Med. 2013 Oct 31;369(18):1691-703. doi: 10.1056/NEJMoa1304369. Epub 2013 Oct 16.
PubMed 24131140Suker M, Beumer BR, Sadot E, Marthey L, Faris JE, Mellon EA, El-Rayes BF, Wang-Gillam A, Lacy J, Hosein PJ, Moorcraft SY, Conroy T, Hohla F, Allen P, Taieb J, Hong TS, Shridhar R, Chau I, van Eijck CH, Koerkamp BG. FOLFIRINOX for locally advanced pancreatic cancer: a systematic review and patient-level meta-analysis. Lancet Oncol. 2016 Jun;17(6):801-810. doi: 10.1016/S1470-2045(16)00172-8. Epub 2016 May 6.
PubMed 27160474Philip PA, Lacy J, Portales F, Sobrero A, Pazo-Cid R, Manzano Mozo JL, Kim EJ, Dowden S, Zakari A, Borg C, Terrebonne E, Rivera F, Sastre J, Bathini V, Lopez-Trabada D, Asselah J, Saif MW, Shiansong Li J, Ong TJ, Nydam T, Hammel P. Nab-paclitaxel plus gemcitabine in patients with locally advanced pancreatic cancer (LAPACT): a multicentre, open-label phase 2 study. Lancet Gastroenterol Hepatol. 2020 Mar;5(3):285-294. doi: 10.1016/S2468-1253(19)30327-9. Epub 2020 Jan 14.
PubMed 31953079Kim YJ, Lee WJ, Woo SM, Kim TH, Han SS, Kim BH, Moon SH, Kim SS, Koh YH, Park SJ, Kim JY, Kim DY, Park JW. Comparison of capecitabine and 5-fluorouracil in chemoradiotherapy for locally advanced pancreatic cancer. Radiat Oncol. 2013 Jul 3;8:160. doi: 10.1186/1748-717X-8-160.
PubMed 23822606Huang J, Robertson JM, Margolis J, Balaraman S, Gustafson G, Khilanani P, Nadeau L, Jury R, McIntosh B. Long-term results of full-dose gemcitabine with radiation therapy compared to 5-fluorouracil with radiation therapy for locally advanced pancreas cancer. Radiother Oncol. 2011 May;99(2):114-9. doi: 10.1016/j.radonc.2011.05.038. Epub 2011 May 27.
PubMed 21621866Mukherjee S, Hurt CN, Bridgewater J, Falk S, Cummins S, Wasan H, Crosby T, Jephcott C, Roy R, Radhakrishna G, McDonald A, Ray R, Joseph G, Staffurth J, Abrams RA, Griffiths G, Maughan T. Gemcitabine-based or capecitabine-based chemoradiotherapy for locally advanced pancreatic cancer (SCALOP): a multicentre, randomised, phase 2 trial. Lancet Oncol. 2013 Apr;14(4):317-26. doi: 10.1016/S1470-2045(13)70021-4. Epub 2013 Mar 6.
PubMed 23474363Yang YF, Cao XH, Bao CE, Wan X. Concurrent radiotherapy with oral fluoropyrimidine versus gemcitabine in locally advanced pancreatic cancer: a systematic review and meta-analysis. Onco Targets Ther. 2015 Nov 9;8:3315-22. doi: 10.2147/OTT.S91292. eCollection 2015.
PubMed 26635481Hammel P, Huguet F, van Laethem JL, Goldstein D, Glimelius B, Artru P, Borbath I, Bouche O, Shannon J, Andre T, Mineur L, Chibaudel B, Bonnetain F, Louvet C; LAP07 Trial Group. Effect of Chemoradiotherapy vs Chemotherapy on Survival in Patients With Locally Advanced Pancreatic Cancer Controlled After 4 Months of Gemcitabine With or Without Erlotinib: The LAP07 Randomized Clinical Trial. JAMA. 2016 May 3;315(17):1844-53. doi: 10.1001/jama.2016.4324.
PubMed 27139057Petrelli F, Comito T, Ghidini A, Torri V, Scorsetti M, Barni S. Stereotactic Body Radiation Therapy for Locally Advanced Pancreatic Cancer: A Systematic Review and Pooled Analysis of 19 Trials. Int J Radiat Oncol Biol Phys. 2017 Feb 1;97(2):313-322. doi: 10.1016/j.ijrobp.2016.10.030. Epub 2016 Oct 24.
PubMed 28068239Reyngold M, Parikh P, Crane CH. Ablative radiation therapy for locally advanced pancreatic cancer: techniques and results. Radiat Oncol. 2019 Jun 6;14(1):95. doi: 10.1186/s13014-019-1309-x.
PubMed 31171025Crane CH, O'Reilly EM. Ablative Radiotherapy Doses for Locally Advanced: Pancreatic Cancer (LAPC). Cancer J. 2017 Nov/Dec;23(6):350-354. doi: 10.1097/PPO.0000000000000292.
PubMed 29189331
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study to Assess the Interest of a Sequential Treatment With Gemcitabine/Nab-paclitaxel (GEMBRAX) and Then FOLFIRINOX Followed by Stereotactic Magnetic Resonance-guided Adaptive Radiotherapy in Patients With Locally Advanced Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT04570943
- Acronym / sponsor ID
- GABRINOX-ART / PROICM 2020-04 GAB
- Keywords
- Pancreatic, cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 103 participants (estimated)
- Lead sponsor
- Institut du Cancer de Montpellier - Val d'AurelleUniversity, hospital or other
- Study start
- 16 Jun 2021 (actual)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Jun 2030 (estimated)
- First posted
- 30 Sep 2020 (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.
The aim of this study is to demonstrate the efficacy of intensified and sequential chemotherapy (Gabrinox) comprising Gembrax regimen (Gemcitabine-Abraxane) followed by the Folfirinox regimen (5FU, Oxaliplatin and Irinotecan) in patients with locally advanced pancreatic adenocarcinoma.
The study will also demonstrate the feasibility of combining this intensified chemotherapy with MRI-guided stereotactic radiotherapy in non-progressive patients after the chemotherapy by Gabrinox regimen.
Detailed description
Pancreatic cancer was the third cause of death by cancer worldwide in 2016, surpassing breast cancer. It is estimated that in 2030, pancreatic cancer will become the second cause of death by cancer after lung cancer.
Its prognosis is very poor, with an overall survival (OS) at 5 years, all stages included, of 5.5%. According to the French cancer registry network (FRANCIM), its incidence has more than doubled in men and women between 1990 and 2018. The world standardized incidence rates for men and women were 5.2% and 2.7% in 1990 and 11% and 7% in 2018, respectively. This means a yearly annual increase of 2.7 for men and of 3.8 for women. The often late diagnosis, in 50% of cases at stage 4, and the limited treatment options explain the very low survival rate at 5 years.
Currently, only surgery associated with adjuvant chemotherapy for 6 months allows doubling this survival rate. However, this situation concerns only 20% of cases. Indeed, 50% of pancreatic cancers are discovered at stage 4, and in 30% of patients cancer is detected when not resectable and non-metastatic (i.e. borderline resectable or locally advanced). To make an unresectable cancer resectable is one of the therapeutic strategies under development. However, treatment of locally advanced pancreatic cancer (LAPC) is not standardized. Chemotherapy is a used strategy, but 30% of cases will progress to metastatic disease. Therefore, the need in LAPC to control not only the local disease but also micro-metastases has led to the development of combined strategies with chemotherapy and optimal radiotherapy.
For LAPC, chemotherapy is based on two drug combinations that are classically used for the first-line treatment of metastatic disease: FOLFIRINOX (FFX) (association of 5FU, Oxaliplatin and Irinotecan) and GEMBRAX (GA) (association of gemcitabine and nab-paclitaxel). Their association has been validated by phase 3 studies showing that compared with gemcitabine alone, they allow increasing the response rate by three times (30%), and almost doubling the median survival and progression-free survival, but with higher grade 3 hematologic and neurological toxicities.
FFX and GA have been assessed also in LAPC. Retrospective studies confirmed the high response rate, 30 to 80% according to the study, and a median survival of 9 to 30 months. Recently, two phase 2 studies, evaluated GA alone and GA followed by FFX, respectively, for LAPC, and confirmed the efficacy, with a response rate of 30% and a secondary resection rate of 15% and 30.6%, respectively. Moreover, in patients who underwent tumour resection after treatment, survival was longer than in those not operated (27.4 vs 14.2 months; Hazard Ratio (HZ) = 0.45; p = 0.0035). Overall Survival (OS) (n= 165 patients) was 17.2 months.
GABRINOX is a sequential treatment with GA and then FFX with the aim of limiting chemoresistance, decreasing toxicities and improving dose intensity.
The feasibility and tolerance of this approach as first-line treatment of metastatic disease were validated in a phase 1 study, and its efficacy in a phase 2 study in which the primary objective was reached: objective response rate of 64.9%, disease control rate of 84.2%, progression-free survival (PFS) of 10.5 months, and Overall Survival (OS) of 15.1 months. Its tolerance profile is favorable with lower percentages of patients with neutropenia (34.5%), febrile neutropenia (3.5%), and neurotoxicity (5.2%).
The role of chemo-radiotherapy for LAPC remains controversial. Many old studies showed the interest of this technique for the local and global control in patients with pancreatic cancer.
However, a phase 3 study compared the efficacy of chemo-radiotherapy versus chemotherapy alone in patients without disease progression after chemotherapy with a regimen that is currently considered not optimal (i.e. gemcitabine with/without erlotinib). Although OS (the main endpoint) did not improve in the chemo-radiotherapy arm compared with the chemotherapy arm, PFS was significantly increased in the chemo-radiotherapy arm with a longer period without treatment (6.1 vs 3.7 months, P = 0.02) and a lower percentage of patients with locoregional progression (32% vs 46%, P =0.03). This confirms that radiotherapy is an effective treatment in pancreatic adenocarcinoma, but that the current delivery modalities do not allow significantly improving the patient prognosis. Indeed, the study used 3D conformal radiotherapy with conventional doses and classical fractioning. Retrospective and phase 1 and 2 studies that used more optimized techniques and higher doses reported better local disease control, but without an important impact on survival. Moreover, some studies suggest significant toxicity, particularly in gastrointestinal organs. Intensity-modulated radiotherapy and integrated boost radiotherapy showed promising local control and survival results. This suggests an avenue for technological improvement and dose augmentation to improve patient prognosis.
Stereotactic magnetic resonance-guided adaptive radiotherapy is a new modality for dose delivery that exploits Magnetic Resonance Imaging (MRI)-guided linear accelerators to better target the treatment volume, while optimizing the protection of organs at risk. The tumour localization in the pancreas seems to be particularly suitable for the utilization of MRI-guided linear accelerators because the radiotherapy doses are limited in function of the gastrointestinal organ tolerance: duodenum, stomach, small intestine, colon. Recently, the results of a retrospective, multicentre study on irradiation of patients with LAPC using Magnetic Resonance Imaging (MRIdian® Linac™; Viewray. The study shows that survival was improved in patients who received an augmented irradiation dose. Specifically, the 2-year OS rate was 49% for patients who received a dose higher than 70 Gy and 30% for patients who received a lower equivalent dose. The study did not report significant toxicity in patients who received high-dose radiotherapy according to the optimized modalities with daily dosimetric adjustment and target monitoring at each radiotherapy session. These data suggest that dose intensification and the stereotactic magnetic resonance-guided adaptive radiotherapy technique improve radiotherapy results; however, prospective studies are needed to confirm these data.
Therefore, the phase 2 study GABRINOX-ART in which an intensified chemotherapy regimen (GABRINOX i.e GA followed by FFX) is followed by optimized adjusted radiotherapy (stereotactic magnetic resonance-guided adaptive radiotherapy) seems to be an interesting strategy to evaluate in locally advanced pancreatic cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gabrinox followed by stereotactic radiotherapy | Experimental | Combination Product: Gabrinox, Radiation: MRI-GUIDED STEREOTACTIC RADIOTHERAPYGembrax: Albumin-bound paclitaxel followed by Gemcitabine Day 1,8,15 followed by 2 weeks of rest Folfirinox: Oxaliplatin, irinotecan, leucovorin, 5FU bolus and continuous |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Patient aged from 18 to 75 years at the date of signature of the consent form
- Histologically or cytologically proven pancreatic adenocarcinoma
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1
- Non-resectable tumour according to the National Comprehensive Cancer Network (NCCN) 1.2015 recommendations after external review of imaging data by multidisciplinary experts.
- Non-metastatic cancer confirmed by thorax-abdomen-pelvis computerized tomography (CT) scan and liver MRI
Key exclusion criteria (21 listed)
- Any previous treatment for pancreatic cancer (e.g. chemotherapy, radiotherapy, surgery, targeted therapy, experimental therapy)
- Gilbert's syndrome or homozygous Uridine DiPhosphate Glucuronosyl Transferase 1 A1 (UGT1A1 * 28)
- Other concomitant cancer or history of cancer, except for treated in situ cancer of the cervix , basal cell or squamous cell carcinoma, superficial bladder tumour (Ta, Tis, and T1), or good-prognosis tumour cured without chemotherapy and without signs of disease in the 3 years before inclusion
- Prior radiotherapy likely to overlap with the planned study radiotherapy area (e.g. previous abdominal irradiation).
- Patients with high cardiovascular risk, including, but not limited to, coronary stent or myocardial infarction in the past 6 months.
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 |
|---|---|---|
| GabrinoxRegimen: GEMBRAX Other Names: Albumin bound paclitaxel 125 mg/m² + Gemcitabine 1000 mg/m² Regimen: FOLFIRINOX Other Names: Oxaliplatin 85 mg/m² + Leucovorin 200 mg/m² + Irinotecan 180 mg/m² + 5FU bolus 400mg/m² + 5FU continuous 2400 mg/m² Gembrax + Folfirinox = GABRINOX | Combination product | Gabrinox followed by stereotactic radiotherapy |
| MRI-GUIDED STEREOTACTIC RADIOTHERAPYRadiotherapy will start between 5 and 6 weeks after the last injection of chemotherapy (FOLFIRINOX regimen) in non-progressive patients after Gabrinox. Stereotactic adaptive radiotherapy in five fractions: prescription dose in five fractions of 10 Gy/day on consecutive days. At least two sessions/week should be performed. An interval of at least 18 hours between fractions is recommended. | Radiation | Gabrinox followed by stereotactic radiotherapy |
Primary outcome
Rate of non-progression at 4 months
Time frame: 4 months
(Sequence 1 success = chemotherapy) according to the RECIST v1.1 criteria
Acute gastrointestinal non-toxicity rate
Time frame: 90 days
Absence of toxicity of grade ≥3 related to radiotherapy within 90 days, evaluated using the NCI-CTCAE v5.0 classification (sequence 2 success = radiotherapy)
20 secondary outcomes
Assessment of adverse events due to chemotherapy by using the NCI-CTCAE version 5.0 scale
Time frame: 36 months
Assessment of adverse events due to radiotherapy by using the NCI-CTCAE version 5.0
Time frame: 36 months
Collection of dosimetric results regarding dose/volume from the planned dosimetry, such as coverage of the planning targeted volume (PTV) by the prescription dose in the accumulated dose
Time frame: An average of 9 months after the beginning of treatment (chemotherapy then radiotherapy)
Collection of dosimetric results regarding dose/volume from the planned dosimetry, such as dose received by the gross total volume
Time frame: An average of 9 months after the beginning of treatment (chemotherapy then radiotherapy)
Collection and Summation of the dosimetric results in terms of dose/volume for the adaptive radiotherapy sessions and comparison with the predicted dosimetry
Time frame: An average of 9 months after the beginning of treatment (chemotherapy then radiotherapy)
Correlation of the dose received by organs at risk (duodenum, small intestine, stomach, colon) with the appearance of gastrointestinal toxicities
Time frame: An average of 9 months after the beginning of treatment (chemotherapy then radiotherapy)
Correlation of planning target volume (PTV) coverage and dose received by the gross tumor volume (GTV) with progression free survival
Time frame: An average of 9 months after the beginning of treatment (chemotherapy then radiotherapy)
Correlation of planning target volume (PTV) coverage and dose received by the gross tumor volume (GTV) with overall survival
Time frame: An average of 9 months after the beginning of treatment (chemotherapy then radiotherapy)
Progression-free Survival (PFS) of the radiotherapy
Time frame: Through study completion, an average of 68 months
Overall Survival (OS) of the radiotherapy
Time frame: Through study completion, an average of 72 months
Local disease control of the radiotherapy
Time frame: Through study completion, an average of 68 months
Progression-free Survival (PFS) of the whole treatement
Time frame: Through study completion, an average of 72 months
Overall Survival (OS) of the whole treatement
Time frame: Through study completion, an average of 72 months
Assessment of adverse events due to the whole treatement
Time frame: Through study completion, an average of 36 months
Resection rate
Time frame: From the end of radiotherapy (3 months) through 6 months post-radiotherapy
Healthy margin resection rate (R0)
Time frame: From the end of radiotherapy (3 months) through 6 months post-radiotherapy
Histological response rate
Time frame: From the end of radiotherapy (3 months) through 6 months post-radiotherapy
Prognostic impact of CA 19-9 changes on survival
Time frame: Through study completion, an average of 36 months
Quality of life by using the quality of life questionnaire score (QLQ-C30)
Time frame: Through study completion, an average of 60 months
Quality of life by using the quality of life questionnaire score (QLQ-PAN26)
Time frame: Through study completion, an average of 60 months
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 5 Dec 2025.
- Background: PubMed 28055103Siegel RL, Miller KD, Jemal A. Cancer Statistics, 2017. CA Cancer J Clin. 2017 Jan;67(1):7-30. doi: 10.3322/caac.21387. Epub 2017 Jan 5.
- Background: PubMed 27551890Ferlay J, Partensky C, Bray F. More deaths from pancreatic cancer than breast cancer in the EU by 2017. Acta Oncol. 2016 Sep-Oct;55(9-10):1158-1160. doi: 10.1080/0284186X.2016.1197419. Epub 2016 Aug 23.
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- 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 24131140Von Hoff DD, Ervin T, Arena FP, Chiorean EG, Infante J, Moore M, Seay T, Tjulandin SA, Ma WW, Saleh MN, Harris M, Reni M, Dowden S, Laheru D, Bahary N, Ramanathan RK, Tabernero J, Hidalgo M, Goldstein D, Van Cutsem E, Wei X, Iglesias J, Renschler MF. Increased survival in pancreatic cancer with nab-paclitaxel plus gemcitabine. N Engl J Med. 2013 Oct 31;369(18):1691-703. doi: 10.1056/NEJMoa1304369. Epub 2013 Oct 16.
- Background: PubMed 27160474Suker M, Beumer BR, Sadot E, Marthey L, Faris JE, Mellon EA, El-Rayes BF, Wang-Gillam A, Lacy J, Hosein PJ, Moorcraft SY, Conroy T, Hohla F, Allen P, Taieb J, Hong TS, Shridhar R, Chau I, van Eijck CH, Koerkamp BG. FOLFIRINOX for locally advanced pancreatic cancer: a systematic review and patient-level meta-analysis. Lancet Oncol. 2016 Jun;17(6):801-810. doi: 10.1016/S1470-2045(16)00172-8. Epub 2016 May 6.
- Background: PubMed 31953079Philip PA, Lacy J, Portales F, Sobrero A, Pazo-Cid R, Manzano Mozo JL, Kim EJ, Dowden S, Zakari A, Borg C, Terrebonne E, Rivera F, Sastre J, Bathini V, Lopez-Trabada D, Asselah J, Saif MW, Shiansong Li J, Ong TJ, Nydam T, Hammel P. Nab-paclitaxel plus gemcitabine in patients with locally advanced pancreatic cancer (LAPACT): a multicentre, open-label phase 2 study. Lancet Gastroenterol Hepatol. 2020 Mar;5(3):285-294. doi: 10.1016/S2468-1253(19)30327-9. Epub 2020 Jan 14.
- Background: PubMed 23822606Kim YJ, Lee WJ, Woo SM, Kim TH, Han SS, Kim BH, Moon SH, Kim SS, Koh YH, Park SJ, Kim JY, Kim DY, Park JW. Comparison of capecitabine and 5-fluorouracil in chemoradiotherapy for locally advanced pancreatic cancer. Radiat Oncol. 2013 Jul 3;8:160. doi: 10.1186/1748-717X-8-160.
- Background: PubMed 21621866Huang J, Robertson JM, Margolis J, Balaraman S, Gustafson G, Khilanani P, Nadeau L, Jury R, McIntosh B. Long-term results of full-dose gemcitabine with radiation therapy compared to 5-fluorouracil with radiation therapy for locally advanced pancreas cancer. Radiother Oncol. 2011 May;99(2):114-9. doi: 10.1016/j.radonc.2011.05.038. Epub 2011 May 27.
- Background: PubMed 23474363Mukherjee S, Hurt CN, Bridgewater J, Falk S, Cummins S, Wasan H, Crosby T, Jephcott C, Roy R, Radhakrishna G, McDonald A, Ray R, Joseph G, Staffurth J, Abrams RA, Griffiths G, Maughan T. Gemcitabine-based or capecitabine-based chemoradiotherapy for locally advanced pancreatic cancer (SCALOP): a multicentre, randomised, phase 2 trial. Lancet Oncol. 2013 Apr;14(4):317-26. doi: 10.1016/S1470-2045(13)70021-4. Epub 2013 Mar 6.
- Background: PubMed 26635481Yang YF, Cao XH, Bao CE, Wan X. Concurrent radiotherapy with oral fluoropyrimidine versus gemcitabine in locally advanced pancreatic cancer: a systematic review and meta-analysis. Onco Targets Ther. 2015 Nov 9;8:3315-22. doi: 10.2147/OTT.S91292. eCollection 2015.
- Background: PubMed 27139057Hammel P, Huguet F, van Laethem JL, Goldstein D, Glimelius B, Artru P, Borbath I, Bouche O, Shannon J, Andre T, Mineur L, Chibaudel B, Bonnetain F, Louvet C; LAP07 Trial Group. Effect of Chemoradiotherapy vs Chemotherapy on Survival in Patients With Locally Advanced Pancreatic Cancer Controlled After 4 Months of Gemcitabine With or Without Erlotinib: The LAP07 Randomized Clinical Trial. JAMA. 2016 May 3;315(17):1844-53. doi: 10.1001/jama.2016.4324.
- Individual participant dataSharing planned: Yes. All data will be available after publication of the results in peer-reviewed revues, and in national and international meetings. It includes all de-identified participants' data, the study protocol, the statistical analysis plan and the clinical study report. The corresponding author will provide data and datasets generated and/or analyzed during the study upon reasonable request.
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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.
Fabienne Portalès, MD study chair
Institut de Cancérologie de Montpellier (ICM)
9 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 Gabrinox and MRI-GUIDED STEREOTACTIC RADIOTHERAPY in people with Locally Advanced Pancreatic Adenocarcinoma, run by Institut du Cancer de Montpellier - Val d'Aurelle at 9 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 20 inclusion and 21 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: looking for participants now, as of the sponsor's last update on 5 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 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, MD (0467612446 ext. +33, Aurore.Moussion@icm.unicancer.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of non-progression at 4 months (time frame: 4 months). The study lists 2 primary outcomes in all. 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 NCT04570943, which also lists 26 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 5 Dec 2025; AzTrials last refreshed its copy on 7 Nov 2026.