[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100445654":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":39,"centralContacts":48,"locations":58,"responsibleParty":183,"collaborators":185,"id":191,"slug":192,"hasResults":193,"nctId":194,"briefTitle":195,"officialTitle":196,"acronym":197,"eligibilityCriteria":198,"healthyVolunteers":193,"sex":199,"minAge":200,"maxAge":34,"enrollmentInfo":201,"targetDuration":34,"studyType":204,"phases":205,"briefSummary":207,"conditions":208,"keywords":212,"overallStatus":61,"whyStopped":34,"lastUpdateSubmitDate":217,"lastUpdatePostDateStruct":218,"startDateStruct":221,"completionDateStruct":223,"leadSponsor":225,"locationsCount":226},{"fullName":5,"class":6},"Erasme University Hospital","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Arm A","ACTIVE_COMPARATOR","mFOLFIRINOX (oxaliplatin: 85 mg\u002Fm2, CPT-11: 165-180 mg\u002Fm2, folinic acid: 400mg\u002Fm2 and 5FU 2000-2400 mg\u002Fm2\u002F46 h) regimen for 8 cycles every 2 weeks; or\\*Gemcitabine-Nab-P: gem: 1000 mg\u002Fm2 weekly 3 w\u002F4; nab-P: 125 mg\u002Fm2 3 w\u002F4 for 4 cycles in case of unfit for mFFX).",[13,14],"Drug: mFOLFIRINOX or Gemcitabine nab-paclitaxel","Procedure: Surgery",{"label":16,"type":17,"description":18,"interventionNames":19},"Arm B","EXPERIMENTAL","mFOLFIRINOX for 6 cycles (or for 3 cycles Gemcitabine-Nab-P: gem: 1000 mg\u002Fm2 weekly 3 w\u002F4; nab-P: 125 mg\u002Fm2 3 w\u002F4 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)",[13,20,14],"Radiation: Isotoxic High-Dose (iHD)-SBRT",[22,29,35],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"DRUG","mFOLFIRINOX or Gemcitabine nab-paclitaxel","oxaliplatin IV, irinotecan IV, leucovorin IV and 5-FU IV OR Gemcitabine IV Nab paclitaxel",[9,16],[28],"mFFX or Gem\u002FNab-p",{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":34},"RADIATION","Isotoxic High-Dose (iHD)-SBRT","Radiation therapy",[16],null,{"type":36,"name":37,"description":37,"armGroupLabels":38,"otherNames":34},"PROCEDURE","Surgery",[9,16],[40,44],{"name":41,"affiliation":42,"role":43},"Jean-Luc Van Laethem, MD","Erasme Hospital, ULB","STUDY_CHAIR",{"name":45,"affiliation":46,"role":47},"Christelle Bouchart, MD","Jules Bordet Institute","PRINCIPAL_INVESTIGATOR",[49,54],{"name":50,"role":51,"phone":52,"phoneExt":34,"email":53},"Jean-Luc Van Laethem, MD PhD","CONTACT","003225553714","jl.vanlaethem@erasme.ulb.ac.be",{"name":55,"role":51,"phone":56,"phoneExt":34,"email":57},"Mia Persoons","003225553016","mia.persoons@erasme.ulb.ac.be",[59,76,88,97,107,117,131,144,157,170],{"facility":60,"status":61,"city":62,"state":34,"zip":63,"country":64,"countryCode":65,"cosmosGeoPoint":66,"geoPoint":71,"contacts":72},"Uza Antwerp","RECRUITING","Antwerp","2650","Belgium","BE",{"type":67,"coordinates":68},"Point",[69,70],4.40026,51.22047,{"lat":70,"lon":69},[73],{"name":74,"role":51,"phone":34,"phoneExt":34,"email":75},"Timon Vandamme, MD","Timon.vandamme@uza.be",{"facility":77,"status":61,"city":78,"state":34,"zip":79,"country":64,"countryCode":65,"cosmosGeoPoint":80,"geoPoint":84,"contacts":85},"Hopital Erasme, HUB","Brussels","1070",{"type":67,"coordinates":81},[82,83],4.34878,50.85045,{"lat":83,"lon":82},[86,87],{"name":41,"role":51,"phone":52,"phoneExt":34,"email":53},{"name":55,"role":51,"phone":56,"phoneExt":34,"email":57},{"facility":89,"status":61,"city":78,"state":34,"zip":79,"country":64,"countryCode":65,"cosmosGeoPoint":90,"geoPoint":92,"contacts":93},"Jules Bordet Institute, HUB",{"type":67,"coordinates":91},[82,83],{"lat":83,"lon":82},[94],{"name":45,"role":51,"phone":95,"phoneExt":34,"email":96},"+32 2 541 38 00","christelle.bouchart@bordet.be",{"facility":98,"status":61,"city":78,"state":34,"zip":99,"country":64,"countryCode":65,"cosmosGeoPoint":100,"geoPoint":102,"contacts":103},"CHIREC","1160",{"type":67,"coordinates":101},[82,83],{"lat":83,"lon":82},[104],{"name":105,"role":51,"phone":34,"phoneExt":34,"email":106},"Francesco Puleo, MD","francesco_puleo@hotmail.com",{"facility":108,"status":61,"city":78,"state":34,"zip":109,"country":64,"countryCode":65,"cosmosGeoPoint":110,"geoPoint":112,"contacts":113},"Cliniques Universitaires St luc","1200",{"type":67,"coordinates":111},[82,83],{"lat":83,"lon":82},[114],{"name":115,"role":51,"phone":34,"phoneExt":34,"email":116},"Ivan Borbath, MD","ivan.borbath@uclouvain.be",{"facility":118,"status":119,"city":120,"state":34,"zip":121,"country":64,"countryCode":65,"cosmosGeoPoint":122,"geoPoint":126,"contacts":127},"UZ Gent","NOT_YET_RECRUITING","Ghent","9000",{"type":67,"coordinates":123},[124,125],3.71667,51.05,{"lat":125,"lon":124},[128],{"name":129,"role":51,"phone":34,"phoneExt":34,"email":130},"Karen Geboes, MD","karen.Geboes@uzgent.be",{"facility":132,"status":61,"city":133,"state":34,"zip":134,"country":64,"countryCode":65,"cosmosGeoPoint":135,"geoPoint":139,"contacts":140},"AZ Groeninge","Kortrijk","8500",{"type":67,"coordinates":136},[137,138],3.26487,50.82803,{"lat":138,"lon":137},[141],{"name":142,"role":51,"phone":34,"phoneExt":34,"email":143},"Philippe Vergauwe, MD","philippe.vergauwe@azgroeninge.be",{"facility":145,"status":61,"city":146,"state":34,"zip":147,"country":64,"countryCode":65,"cosmosGeoPoint":148,"geoPoint":152,"contacts":153},"Pôle Hospitalier Jolimont","La Louvière","7100",{"type":67,"coordinates":149},[150,151],4.18785,50.48657,{"lat":151,"lon":150},[154],{"name":155,"role":51,"phone":34,"phoneExt":34,"email":156},"Alexandre Dermine, MD","alexandre.dermine@jolimont.be",{"facility":158,"status":61,"city":159,"state":34,"zip":160,"country":64,"countryCode":65,"cosmosGeoPoint":161,"geoPoint":165,"contacts":166},"Clinique Chc Montlégia","Liège","4000",{"type":67,"coordinates":162},[163,164],5.56749,50.63373,{"lat":164,"lon":163},[167],{"name":168,"role":51,"phone":34,"phoneExt":34,"email":169},"Ghislain Houbiers, MD","ghislain.houbiers@chc.be",{"facility":171,"status":61,"city":172,"state":34,"zip":173,"country":64,"countryCode":65,"cosmosGeoPoint":174,"geoPoint":178,"contacts":179},"CHU Ambroise Paré","Mons","7000",{"type":67,"coordinates":175},[176,177],3.95229,50.45413,{"lat":177,"lon":176},[180],{"name":181,"role":51,"phone":34,"phoneExt":34,"email":182},"Marie Diaz, MD","marie.diaz@hap.be",{"type":184,"investigatorFullName":34,"investigatorTitle":34,"investigatorAffiliation":34,"oldNameTitle":34,"oldOrganization":34},"SPONSOR",[186,187,189],{"name":46,"class":6},{"name":188,"class":6},"Belgian Group of Digestive Oncology",{"name":190,"class":6},"University Hospital St Luc, Brussels","100445654","phase-2-preoperative-mfolfirinox-or-gem-nab-p---isotoxic-high-dose-sbrt-for-borderline-resectable-pancreatic-adenocarcinoma-100445654",false,"NCT05083247","Preoperative mFOLFIRINOX (or Gem-Nab-P) +\u002F- Isotoxic High-dose SBRT for Borderline Resectable Pancreatic Adenocarcinoma","Preoperative Treatment With mFOLFIRINOX (or Gem-Nab-P) +\u002F- Isotoxic High-dose Stereotactic Body Radiation Therapy (iHD-SBRT) for Borderline Resectable Pancreatic Adenocarcinoma: a Randomised Phase II Study (STEREOPAC)","STEREOPAC","Inclusion criteria:\n\n* Cytologic or histologic proof of adenocarcinoma of the pancreatic head or uncinated process or body or tail. Diagnosis should be verified by local pathologist\n* cTNM stage: T1-4N0-2M0\n* Confirmation of clinical and radiographic stage as borderline resectable (CT scan and\u002For MRI scan with contrast according to the NCCN criteria) by a multidisciplinary board, composed by a dedicated oncological surgeon, radiologist and GI oncologist)\n* Age \\> 18 years old\n* No prior chemotherapy or radiation for pancreatic cancer\n* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1\n* No grade ≥ 2 neuropathy\n* Laboratory parameters as follows:\n* Absolute neutrophil count (ANC) ≥ 1,500\u002Fmm³\n* Platelet count ≥ 100,000\u002Fmm³\n* Hemoglobin ≥ 9 g\u002FdL\n* Creatinine ≤ 1.5 x upper limit of normal (ULN) or estimated GFR \\>45 mL\u002Fmin\n* Bilirubin ≤ 1.5 x ULN, including after adequate biliary stenting with metal stent (ideally 4 cm length)\n* Aspartate aminotransferase (AST) \u002F alanine aminotransferase (ALT) ≤ 2.5x ULN\n* CA 19.9 \\\u003C 2500 kU\u002Fl (baseline, prior to any therapy and absence of cholestasis)\n\nExclusion Criteria:\n\n* 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\u002For distant metastases\n* Locally advanced disease as defined by the NCCN criteria (version 2.2021) ie \\> 180° arterial encasement (SMA and CA) unreconstructible venous encasement (SMV\u002FPV) due to tumor involvement or occlusion of a long segment.\n* CA 19.9 \\> 2500 kU\u002Fl (baseline and absence of cholestasis)\n* Contraindication of surgery (general)\n* Contraindications to receive FFX or gemcitabine-nab-Paclitaxel\n* History of radiotherapy of the upper abdomen\n* Prior treatment with oxaliplatin, irinotecan, fluoruouracil or capecitabin\n* Patient \\\u003C 18 years old\n* Major surgery within 4 weeks of study entry\n* Uncontrolled pre-existing disease including, but not limited to: active infection, symptomatic congestive heart failure, unstable angina, social \u002F psychiatric disorder that would limit compliance to treatment and good understanding of the informed consent form\n* Other concurrent anticancer therapies\n* 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\n* Pregnant or breastfeeding women; for women of childbearing potential only, a negative pregnancy test done \\\u003C 7 days prior to registration is required. Using of reliable contraception for at least 1 month before treatment is mandatory\n* 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\n\nAdditional exclusion criteria before randomisation:\n\n* 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\u002FNP), including shift chemotherapy in case of early progression.\n* CA 19.9 \\> 1000 kU\u002Fl after neoadjuvant therapy.\n* Presence of unmanageable toxicity during the first part of neoadjuvant chemotherapy (first 4 cycles or 6 doses of FFX or G\u002FNP, respectively.\n* Pancreatic tumour \\> 7.0 cm in greatest axial dimension at the time of randomization\n* Massive invasion of the stomach or intestines and\u002For direct intestinal invasion of the mucosae visible at ultrasoundendoscopy\n* 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)","ALL","18 Years",{"count":202,"type":203},256,"ESTIMATED","INTERVENTIONAL",[206],"PHASE2","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.",[209,210,211],"Pancreatic Neoplasm","Pancreatic Adenocarcinoma","Borderline Resectable Pancreatic Adenocarcinoma",[213,214,215,216],"borderline resectable pancreatic cancer","neoadjuvant therapy","stereotactic body radiation therapy","chemotherapy","2023-05-22",{"date":219,"type":220},"2023-05-23","ACTUAL",{"date":222,"type":220},"2023-03-24",{"date":224,"type":203},"2030-12-31",{"name":5,"class":6},10]