Pancreatic NeoplasmPhase 2STEREOPACNCT05083247
Preoperative mFOLFIRINOX (or Gem-Nab-P) +/- Isotoxic High-dose SBRT for Borderline Resectable Pancreatic Adenocarcinoma
A Phase 2 study testing mFOLFIRINOX or Gemcitabine nab-paclitaxel, Isotoxic High-Dose (iHD)-SBRT and Surgery in people with Pancreatic Neoplasm and Pancreatic Adenocarcinoma, run by Erasme University Hospital at 10 sites in Belgium.
Trial summary
Surgical resection is the only potentially curative treatment for patients with pancreatic cancer with the aim of curative R0 resection and related improvement of survival. As a standard, surgery is usually followed by adjuvant therapy that improves survival but neoadjuvant therapy (NAT) is a rapidly emerging concept… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Neoplasm, Pancreatic Adenocarcinoma, Borderline Resectable Pancreatic Adenocarcinoma
- What is being tested?
- mFOLFIRINOX or Gemcitabine nab-paclitaxel, Isotoxic High-Dose (iHD)-SBRT and Surgery
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 256 participants
- Where
- 10 sitesBelgium
- Study dates
- 24 Mar 2023to 31 Dec 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cytologic or histologic proof of adenocarcinoma of the pancreatic head or uncinated process or body or tail. Diagnosis should be verified by local pathologist
- cTNM stage: T1-4N0-2M0
- Confirmation of clinical and radiographic stage as borderline resectable (CT scan and/or MRI scan with contrast according to the NCCN criteria) by a multidisciplinary board, composed by a dedicated oncological surgeon, radiologist and GI oncologist)
- Age > 18 years old
- No prior chemotherapy or radiation for pancreatic cancer
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
Show all 15Show fewer
- No grade ≥ 2 neuropathy
- Laboratory parameters as follows:
- Absolute neutrophil count (ANC) ≥ 1,500/mm³
- Platelet count ≥ 100,000/mm³
- Hemoglobin ≥ 9 g/dL
- Creatinine ≤ 1.5 x upper limit of normal (ULN) or estimated GFR >45 mL/min
- Bilirubin ≤ 1.5 x ULN, including after adequate biliary stenting with metal stent (ideally 4 cm length)
- Aspartate aminotransferase (AST) / alanine aminotransferase (ALT) ≤ 2.5x ULN
- CA 19.9 < 2500 kU/l (baseline, prior to any therapy and absence of cholestasis)
Who cannot join
- Evidence of extrapancreatic disease on diagnostic imaging (CT, MRI or PET scan), histologically proven or at laparoscopy, including distal nodal involvement beyond the peripancreatic tissues (including non-regional lymph node involvement, ie: proven involvement of precaval lumbar lymphadenopathy(ies) and/or distant metastases
- Locally advanced disease as defined by the NCCN criteria (version 2.2021) ie > 180° arterial encasement (SMA and CA) unreconstructible venous encasement (SMV/PV) due to tumor involvement or occlusion of a long segment.
- CA 19.9 > 2500 kU/l (baseline and absence of cholestasis)
- Contraindication of surgery (general)
- Contraindications to receive FFX or gemcitabine-nab-Paclitaxel
- History of radiotherapy of the upper abdomen
Show all 21Show fewer
- Prior treatment with oxaliplatin, irinotecan, fluoruouracil or capecitabin
- Patient < 18 years old
- Major surgery within 4 weeks of study entry
- Uncontrolled pre-existing disease including, but not limited to: active infection, symptomatic congestive heart failure, unstable angina, social / psychiatric disorder that would limit compliance to treatment and good understanding of the informed consent form
- Other concurrent anticancer therapies
- Existence of another active neoplasia other than basal cell carcinoma of the skin, cervical carcinoma in situ or non-metastatic prostate cancer. Patients who have a history of neoplasia must have been in remission for more than 5 years to be included in the protocol
- Pregnant or breastfeeding women; for women of childbearing potential only, a negative pregnancy test done < 7 days prior to registration is required. Using of reliable contraception for at least 1 month before treatment is mandatory
- Chronic concomitant treatment with strong inhibitors of cytochrome p450, family 3, subfamily a, polypeptide 4 gene (CYP3A4) is not allowed on this study; patients on strong CYP3A4 inhibitors must discontinue the drug for 14 days prior to registration on the study
- Additional exclusion criteria before randomisation:
- Progressive disease (RECIST or PETCT, including non locoregional nodal involvement and increase of CA 19.9 by 20%) after receiving 4 cycles of FFX (or G/NP), including shift chemotherapy in case of early progression.
- CA 19.9 > 1000 kU/l after neoadjuvant therapy.
- Presence of unmanageable toxicity during the first part of neoadjuvant chemotherapy (first 4 cycles or 6 doses of FFX or G/NP, respectively.
- Pancreatic tumour > 7.0 cm in greatest axial dimension at the time of randomization
- Massive invasion of the stomach or intestines and/or direct intestinal invasion of the mucosae visible at ultrasoundendoscopy
- Active gastric or duodenal ulcer disease at the time of randomization. Tolerated in case of antecedent without active ulcer (confirmation by endoscopy before iHD-SBRT)
Trial locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
10 sites in 1 country
Belgium10 sites, 10 recruiting
- Recruiting
Uza Antwerp
Antwerp, 2650
Timon Vandamme, MD, Timon.vandamme@uza.be
- Recruiting
Hopital Erasme, HUB
Brussels, 1070
Jean-Luc Van Laethem, MD, 003225553714, jl.vanlaethem@erasme.ulb.ac.be
Mia Persoons, 003225553016, mia.persoons@erasme.ulb.ac.be
- Recruiting
Jules Bordet Institute, HUB
Brussels, 1070
Christelle Bouchart, MD, +32 2 541 38 00, christelle.bouchart@bordet.be
- Recruiting
CHIREC
Brussels, 1160
Francesco Puleo, MD, francesco_puleo@hotmail.com
- Recruiting
Cliniques Universitaires St luc
Brussels, 1200
Ivan Borbath, MD, ivan.borbath@uclouvain.be
- Not yet recruiting
UZ Gent
Ghent, 9000
Karen Geboes, MD, karen.Geboes@uzgent.be
- Recruiting
AZ Groeninge
Kortrijk, 8500
Philippe Vergauwe, MD, philippe.vergauwe@azgroeninge.be
- Recruiting
Pôle Hospitalier Jolimont
La Louvière, 7100
Alexandre Dermine, MD, alexandre.dermine@jolimont.be
- Recruiting
Clinique Chc Montlégia
Liège, 4000
Ghislain Houbiers, MD, ghislain.houbiers@chc.be
- Recruiting
CHU Ambroise Paré
Mons, 7000
Marie Diaz, MD, marie.diaz@hap.be
About this study
Official title: Preoperative Treatment With mFOLFIRINOX (or Gem-Nab-P) +/- Isotoxic High-dose Stereotactic Body Radiation Therapy (iHD-SBRT) for Borderline Resectable Pancreatic Adenocarcinoma: a Randomised Phase II Study (STEREOPAC)
Surgical resection is the only potentially curative treatment for patients with pancreatic cancer with the aim of curative R0 resection and related improvement of survival. As a standard, surgery is usually followed by adjuvant therapy that improves survival but neoadjuvant therapy (NAT) is a rapidly emerging concept that needs to be explored and validated in terms of therapeutic options in borderline resectable pancreatic tumors. In this setting, preoperative FFX seems to be feasible and can be prolonged by radiation therapy. However, the exact and best therapeutic sequence is not yet known and the additional role of adding isotoxic high-dose stereotactic body radiotherapy (iHD-SBRT) to chemotherapy requires validation in randomised trials. We propose to evaluate the impact and efficacy of adding iHD-SBRT to preoperative neoadjuvant mFFX or Gem-NabP in patients with borderline resectable pancreatic adenocarcinoma.
Read the detailed description
STEREOPAC is an multicenter, academic, prospective, randomised comparative, interventional study.
Patients receive 4 cycles of mFOLFIRINOX (or Gem-Nab-P)*. A full restaging (clinical, morphologic imaging, vascular involvement, biologics, CA 19.9) is performed. Non-progressive patients will be randomised (1:1) to
ARM A for receiving 4 additional cycles of chemo followed by surgery.
or to
ARM B for receiving 5th and 6th cycles of chemo then iHD-SBRT followed by a 7th (and optional 8th cycle) followed by surgery.
*: in case of CI or intolerance to mFFX, Gem-Nab-P regimen can be chosen or shifted to for 6 doses, then restaging, and then 3 doses followed by SBRT or 6 doses and immediate surgery)
Adjuvant chemotherapy administration is indicated unless the patient's condition precludes it.
- Conditions
- Pancreatic Neoplasm, Pancreatic Adenocarcinoma, Borderline Resectable Pancreatic Adenocarcinoma
- Being tested
- mFOLFIRINOX or Gemcitabine nab-paclitaxel, Isotoxic High-Dose (iHD)-SBRT, Surgery
- Keywords
- borderline resectable pancreatic cancer, neoadjuvant therapy, stereotactic body radiation therapy, chemotherapy
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mFOLFIRINOX or Gemcitabine nab-paclitaxelDrug
Also called mFFX or Gem/Nab-p
oxaliplatin IV, irinotecan IV, leucovorin IV and 5-FU IV OR Gemcitabine IV Nab paclitaxel
Isotoxic High-Dose (iHD)-SBRTRadiation
Radiation therapy
SurgeryProcedure or surgery
Surgery
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Active comparator | mFOLFIRINOX (oxaliplatin: 85 mg/m2, CPT-11: 165-180 mg/m2, folinic acid: 400mg/m2 and 5FU 2000-2400 mg/m2/46 h) regimen for 8 cycles every 2 weeks; or*Gemcitabine-Nab-P: gem: 1000 mg/m2 weekly 3 w/4; nab-P: 125 mg/m2 3 w/4 for 4 cycles in case of unfit for mFFX). Receives: Drug: mFOLFIRINOX or Gemcitabine nab-paclitaxel; Procedure: Surgery |
| Arm B | Experimental | mFOLFIRINOX for 6 cycles (or for 3 cycles Gemcitabine-Nab-P: gem: 1000 mg/m2 weekly 3 w/4; nab-P: 125 mg/m2 3 w/4 in case of unfit for mFFX) +Isotoxic high-dose SBRT: 5 x 7Gy with Simultaneous Integrated Boost (SIB) up to maximum 55Gy (= 1 week; starting ideally 2 weeks and maximum within 4 weeks after the end of chemotherapy) Receives: Drug: mFOLFIRINOX or Gemcitabine nab-paclitaxel; Radiation: Isotoxic High-Dose (iHD)-SBRT; Procedure: Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease free survival
Defined as time from randomisation to the first documentation of event where events considered are 1) disease progression, per RECIST, prior to surgery, 2) discovery of hepatic or peritoneal carcinomatosis during surgical exploration, 3) recurrent disease following R0-R1 surgery, or 4) death due to any cause.
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 weeks
R0 Resection rate
Defined as the proportion of eligible randomised patients in whom a R0 resection was achieved during surgery after neoadjuvant treatment with FOLFIRINOX +/- iHD-SBRT. R0 resection indicates a microscopically margin-negative resection (>1 mm) from the inked margins (pancreatic transection, vascular and posterior circumferential resection margins).
Measured: up to 12 months
Secondary outcomes (12)
Resection rate
defined as the percentage of eligible randomised patients that underwent a curative-intent resection
Measured: up to 12 months
Pathologic complete/major response (pCR)
Defined as the proportion of patients in whom a pCR or a major (<10% of residual tumour cells) was confirmed by histopathologic review of the surgical specimen.
Measured: up to 12 months
Complete feasibility of the therapeutic sequence
Defined as the proportion of patient who performed completely the neoadjuvant therapeutic sequence with mFFX (or Gem-Nab-P) +/- iHD-SBRT until surgery (abdominal exploration with or without pancreatectomy). The therapeutic sequence will not be considered as feasible if less than 60% of patients do not complete it until surgery.
Measured: up to 12 months
Overall survival (OS)
Defined as the time interval between randomisation and death. 95% confidence interval will be estimated based on standard method.
Measured: Defined as the time interval between randomisation and death, assessed up to 60 months
Locoregional failure free interval (LFFI)
defined as the time interval between the randomisation and the date of locoregional failure. A locoregional failure is any progressive or recurrent pancreatic cancer in the original tumour location or the N1-2 lymph node areas
Measured: defined as the time interval between the randomisation and the 1st documented date of locoregional failure, assessed up to 60 months
Distant metastases free interval (DMFI)
defined as the period of time without distant metastasis after randomisation.
Measured: defined as the period of time without distant metastasis after randomisation, assessed up to 60 months
Toxicity, Incidence of adverse events
assessed per Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 and the Patient-Reported Outcomes version of the CTCAE
Measured: up to 24 months
Postoperative complications
defined according to the Clavien-Dindo classification and definitions of post-pancreatic surgery complications (pancreatic fistula, delayed gastric emptying and bleeding) by the International study group on Pancreatic Surgery.
Measured: up to 12 months
Quality of life (QoL) assessment - General
assessed per EORTC General Quality of life of Cancer patient questionnaire QLQ-C30 version 3.0 (minimum value: 30 - maximum value: 126; higher score associated with worse QoL outcome).
Measured: up to 24 months
Quality of life (QoL) assessment - Pancreatic cancer
assessed per EORTC Quality of life of Pancreatic Cancer patient questionnaire QLQ-PAN26 (minimum value: 26 - maximum value: 104; higher score associated with worse QoL outcome).
Measured: up to 24 months
Quality of life (QoL) assessment - Depression
assessed per the depression test : Patient Health Questionnaire-9 (PHQ-9; minimum value: 0 - maximum value: 27; higher score associated with worse QoL outcome)
Measured: up to 24 months
Technical and quality success rate of EUS-delivered fiducials.
The technical success is defined as at least one marker presumed to be inside the tumour at the end of the EUS procedure. The quality success is defined as a score equal or higher than 6/12 points based on the 5 items quality score defined in [Figueiredo M, Bouchart C et al 2021].
Measured: up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2021
- Study start24 Mar 2023
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2030 (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 NeoplasmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- comparative randomised phase II
- Masking
- None (open label)
- Enrolment
- 256 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erasme University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Jules Bordet Institute, Belgian Group of Digestive Oncology, University Hospital St Luc, Brussels
- Responsible party
- Sponsor
- Investigators
- Jean-Luc Van Laethem, MD, Study chair, Erasme Hospital, ULBChristelle Bouchart, MD, Principal investigator, Jules Bordet Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05083247
- Sponsor's protocol ID
- ERA 001
- Acronym
- STEREOPAC
- Status last verified
- Mar 2023
- First submitted
- 29 Sep 2021
- Last updated
- 23 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Figueiredo M, Bouchart C, Moretti L, Mans L, Engelholm JL, Bali MA, Van Laethem JL, Eisendrath P. EUS-guided placement of fiducial markers for stereotactic body radiation therapy in pancreatic cancer: feasibility, security and a new quality score. Endosc Int Open. 2021 Feb;9(2):E253-E257. doi: 10.1055/a-1324-2892. Epub 2021 Feb 3.
PubMed 33553589Bouchart C, Engelholm JL, Closset J, Navez J, Loi P, Gokburun Y, De Grez T, Mans L, Hendlisz A, Bali MA, Eisendrath P, Van Gestel D, Hein M, Moretti L, Van Laethem JL. Isotoxic high-dose stereotactic body radiotherapy integrated in a total multimodal neoadjuvant strategy for the treatment of localized pancreatic ductal adenocarcinoma. Ther Adv Med Oncol. 2021 Oct 19;13:17588359211045860. doi: 10.1177/17588359211045860. eCollection 2021.
PubMed 34691244Manderlier M, Navez J, Hein M, Engelholm JL, Closset J, Bali MA, Van Gestel D, Moretti L, Van Laethem JL, Bouchart C. Isotoxic High-Dose Stereotactic Body Radiotherapy (iHD-SBRT) Versus Conventional Chemoradiotherapy for Localized Pancreatic Cancer: A Single Cancer Center Evaluation. Cancers (Basel). 2022 Nov 22;14(23):5730. doi: 10.3390/cancers14235730.
PubMed 36497212Bouchart C, Navez J, Borbath I, Geboes K, Vandamme T, Closset J, Moretti L, Demetter P, Paesmans M, Van Laethem JL. Preoperative treatment with mFOLFIRINOX or Gemcitabine/Nab-paclitaxel +/- isotoxic high-dose stereotactic body Radiation Therapy (iHD-SBRT) for borderline resectable pancreatic adenocarcinoma (the STEREOPAC trial): study protocol for a randomised comparative multicenter phase II trial. BMC Cancer. 2023 Sep 21;23(1):891. doi: 10.1186/s12885-023-11327-x.
PubMed 37735634
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Treatment With mFOLFIRINOX (or Gem-Nab-P) +/- Isotoxic High-dose Stereotactic Body Radiation Therapy (iHD-SBRT) for Borderline Resectable Pancreatic Adenocarcinoma: a Randomised Phase II Study (STEREOPAC)
- ClinicalTrials.gov ID
- NCT05083247
- Acronym / sponsor ID
- STEREOPAC / ERA 001
- Conditions
- Pancreatic Neoplasm, Pancreatic Adenocarcinoma, Borderline Resectable Pancreatic Adenocarcinoma
- Keywords
- borderline resectable pancreatic cancer, neoadjuvant therapy, stereotactic body radiation therapy, chemotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 256 participants (estimated)
- Lead sponsor
- Erasme University HospitalUniversity, hospital or other
- Collaborators
- Jules Bordet Institute, Belgian Group of Digestive Oncology, University Hospital St Luc, Brussels
- Study start
- 24 Mar 2023 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 19 Oct 2021 (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.
Surgical resection is the only potentially curative treatment for patients with pancreatic cancer with the aim of curative R0 resection and related improvement of survival. As a standard, surgery is usually followed by adjuvant therapy that improves survival but neoadjuvant therapy (NAT) is a rapidly emerging concept that needs to be explored and validated in terms of therapeutic options in borderline resectable pancreatic tumors. In this setting, preoperative FFX seems to be feasible and can be prolonged by radiation therapy. However, the exact and best therapeutic sequence is not yet known and the additional role of adding isotoxic high-dose stereotactic body radiotherapy (iHD-SBRT) to chemotherapy requires validation in randomised trials. We propose to evaluate the impact and efficacy of adding iHD-SBRT to preoperative neoadjuvant mFFX or Gem-NabP in patients with borderline resectable pancreatic adenocarcinoma.
Detailed description
STEREOPAC is an multicenter, academic, prospective, randomised comparative, interventional study.
Patients receive 4 cycles of mFOLFIRINOX (or Gem-Nab-P)*. A full restaging (clinical, morphologic imaging, vascular involvement, biologics, CA 19.9) is performed. Non-progressive patients will be randomised (1:1) to
ARM A for receiving 4 additional cycles of chemo followed by surgery.
or to
ARM B for receiving 5th and 6th cycles of chemo then iHD-SBRT followed by a 7th (and optional 8th cycle) followed by surgery.
*: in case of CI or intolerance to mFFX, Gem-Nab-P regimen can be chosen or shifted to for 6 doses, then restaging, and then 3 doses followed by SBRT or 6 doses and immediate surgery)
Adjuvant chemotherapy administration is indicated unless the patient's condition precludes it.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- comparative randomised phase II
| Arm | Type | Receives |
|---|---|---|
| Arm A | Active comparator | Drug: mFOLFIRINOX or Gemcitabine nab-paclitaxel, Procedure: SurgerymFOLFIRINOX (oxaliplatin: 85 mg/m2, CPT-11: 165-180 mg/m2, folinic acid: 400mg/m2 and 5FU 2000-2400 mg/m2/46 h) regimen for 8 cycles every 2 weeks; or*Gemcitabine-Nab-P: gem: 1000 mg/m2 weekly 3 w/4; nab-P: 125 mg/m2 3 w/4 for 4 cycles in case of unfit for mFFX). |
| Arm B | Experimental | Drug: mFOLFIRINOX or Gemcitabine nab-paclitaxel, Radiation: Isotoxic High-Dose (iHD)-SBRT, Procedure: SurgerymFOLFIRINOX for 6 cycles (or for 3 cycles Gemcitabine-Nab-P: gem: 1000 mg/m2 weekly 3 w/4; nab-P: 125 mg/m2 3 w/4 in case of unfit for mFFX) +Isotoxic high-dose SBRT: 5 x 7Gy with Simultaneous Integrated Boost (SIB) up to maximum 55Gy (= 1 week; starting ideally 2 weeks and maximum within 4 weeks after the end of chemotherapy) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Cytologic or histologic proof of adenocarcinoma of the pancreatic head or uncinated process or body or tail. Diagnosis should be verified by local pathologist
- cTNM stage: T1-4N0-2M0
- Confirmation of clinical and radiographic stage as borderline resectable (CT scan and/or MRI scan with contrast according to the NCCN criteria) by a multidisciplinary board, composed by a dedicated oncological surgeon, radiologist and GI oncologist)
- Age > 18 years old
- No prior chemotherapy or radiation for pancreatic cancer
Key exclusion criteria (21 listed)
- Evidence of extrapancreatic disease on diagnostic imaging (CT, MRI or PET scan), histologically proven or at laparoscopy, including distal nodal involvement beyond the peripancreatic tissues (including non-regional lymph node involvement, ie: proven involvement of precaval lumbar lymphadenopathy(ies) and/or distant metastases
- Locally advanced disease as defined by the NCCN criteria (version 2.2021) ie > 180° arterial encasement (SMA and CA) unreconstructible venous encasement (SMV/PV) due to tumor involvement or occlusion of a long segment.
- CA 19.9 > 2500 kU/l (baseline and absence of cholestasis)
- Contraindication of surgery (general)
- Contraindications to receive FFX or gemcitabine-nab-Paclitaxel
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 |
|---|---|---|
| mFOLFIRINOX or Gemcitabine nab-paclitaxelAlso: mFFX or Gem/Nab-poxaliplatin IV, irinotecan IV, leucovorin IV and 5-FU IV OR Gemcitabine IV Nab paclitaxel | Drug | Arm A, Arm B |
| Isotoxic High-Dose (iHD)-SBRTRadiation therapy | Radiation | Arm B |
| SurgerySurgery | Procedure or surgery | Arm A, Arm B |
Primary outcome
Disease free survival
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 weeks
Defined as time from randomisation to the first documentation of event where events considered are 1) disease progression, per RECIST, prior to surgery, 2) discovery of hepatic or peritoneal carcinomatosis during surgical exploration, 3) recurrent disease following R0-R1 surgery, or 4) death due to any cause.
R0 Resection rate
Time frame: up to 12 months
Defined as the proportion of eligible randomised patients in whom a R0 resection was achieved during surgery after neoadjuvant treatment with FOLFIRINOX +/- iHD-SBRT. R0 resection indicates a microscopically margin-negative resection (>1 mm) from the inked margins (pancreatic transection, vascular and posterior circumferential resection margins).
12 secondary outcomes
Resection rate
Time frame: up to 12 months
Pathologic complete/major response (pCR)
Time frame: up to 12 months
Complete feasibility of the therapeutic sequence
Time frame: up to 12 months
Overall survival (OS)
Time frame: Defined as the time interval between randomisation and death, assessed up to 60 months
Locoregional failure free interval (LFFI)
Time frame: defined as the time interval between the randomisation and the 1st documented date of locoregional failure, assessed up to 60 months
Distant metastases free interval (DMFI)
Time frame: defined as the period of time without distant metastasis after randomisation, assessed up to 60 months
Toxicity, Incidence of adverse events
Time frame: up to 24 months
Postoperative complications
Time frame: up to 12 months
Quality of life (QoL) assessment - General
Time frame: up to 24 months
Quality of life (QoL) assessment - Pancreatic cancer
Time frame: up to 24 months
Quality of life (QoL) assessment - Depression
Time frame: up to 24 months
Technical and quality success rate of EUS-delivered fiducials.
Time frame: up to 12 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 23 May 2023.
- Background: PubMed 33553589Figueiredo M, Bouchart C, Moretti L, Mans L, Engelholm JL, Bali MA, Van Laethem JL, Eisendrath P. EUS-guided placement of fiducial markers for stereotactic body radiation therapy in pancreatic cancer: feasibility, security and a new quality score. Endosc Int Open. 2021 Feb;9(2):E253-E257. doi: 10.1055/a-1324-2892. Epub 2021 Feb 3.
- Background: PubMed 34691244Bouchart C, Engelholm JL, Closset J, Navez J, Loi P, Gokburun Y, De Grez T, Mans L, Hendlisz A, Bali MA, Eisendrath P, Van Gestel D, Hein M, Moretti L, Van Laethem JL. Isotoxic high-dose stereotactic body radiotherapy integrated in a total multimodal neoadjuvant strategy for the treatment of localized pancreatic ductal adenocarcinoma. Ther Adv Med Oncol. 2021 Oct 19;13:17588359211045860. doi: 10.1177/17588359211045860. eCollection 2021.
- Background: PubMed 36497212Manderlier M, Navez J, Hein M, Engelholm JL, Closset J, Bali MA, Van Gestel D, Moretti L, Van Laethem JL, Bouchart C. Isotoxic High-Dose Stereotactic Body Radiotherapy (iHD-SBRT) Versus Conventional Chemoradiotherapy for Localized Pancreatic Cancer: A Single Cancer Center Evaluation. Cancers (Basel). 2022 Nov 22;14(23):5730. doi: 10.3390/cancers14235730.
- Derived from this study: PubMed 37735634Bouchart C, Navez J, Borbath I, Geboes K, Vandamme T, Closset J, Moretti L, Demetter P, Paesmans M, Van Laethem JL. Preoperative treatment with mFOLFIRINOX or Gemcitabine/Nab-paclitaxel +/- isotoxic high-dose stereotactic body Radiation Therapy (iHD-SBRT) for borderline resectable pancreatic adenocarcinoma (the STEREOPAC trial): study protocol for a randomised comparative multicenter phase II trial. BMC Cancer. 2023 Sep 21;23(1):891. doi: 10.1186/s12885-023-11327-x.
- Individual participant dataSharing planned: No
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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.
Jean-Luc Van Laethem, MD study chair
Erasme Hospital, ULB
Christelle Bouchart, MD principal investigator
Jules Bordet Institute
10 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 mFOLFIRINOX or Gemcitabine nab-paclitaxel, Isotoxic High-Dose (iHD)-SBRT and Surgery in people with Pancreatic Neoplasm and Pancreatic Adenocarcinoma, run by Erasme University Hospital at 10 sites in Belgium.
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 15 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 23 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Belgium. 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 Jean-Luc Van Laethem, MD PhD (003225553714, jl.vanlaethem@erasme.ulb.ac.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease free survival (time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 weeks). 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 NCT05083247, 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 23 May 2023.