[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100468372":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":27,"centralContacts":40,"locations":46,"responsibleParty":82,"collaborators":27,"id":84,"slug":85,"hasResults":86,"nctId":87,"briefTitle":88,"officialTitle":89,"acronym":90,"eligibilityCriteria":91,"healthyVolunteers":86,"sex":92,"minAge":93,"maxAge":27,"enrollmentInfo":94,"targetDuration":27,"studyType":97,"phases":98,"briefSummary":100,"conditions":101,"keywords":27,"overallStatus":48,"whyStopped":27,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":112},{"fullName":5,"class":6},"Lithuanian University of Health Sciences","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Arm A (Control): Radiotherapy + fluorouracil","ACTIVE_COMPARATOR","Chemoradiotherapy 5 weeks (50 Grays (Gy), 2 Gy\u002Fsession; 25 fractions) + fluorouracil\u002Fleucovorin 400 mg\u002Fm² 1-4 day the first and fifth weeks of radiotherapy) , then 6-8 weeks after chemoradiation, surgery, followed by adjuvant chemotherapy for 4-6 months, either Folfox4 or fluorouracil, depending on the center's choice.",[13,14],"Radiation: Radiotherapy 50 Gy","Drug: Fluorouracil\u002Ffolic acid",{"label":16,"type":17,"description":18,"interventionNames":19},"Arm B (Experimental): Chemotherapy with Oxaliplatin, fluorouracil, folinic acid (FOLFOX4) regimen","EXPERIMENTAL","Neoadjuvant CT FOLFOX4, 8 cycles (ca. 4 months; each cycle = 2 weeks):\n\noxaliplatin: 85 mg\u002Fm² in 2 hours at D1; folinic acid: 100 mg\u002Fm² simultaneously in 2 hours at D1 and D2 during the Oxaliplatin; bolus 5-fluorouracil (5-FU) 400mg\u002Fm² D1+D2; infusion 5-fluorouracil (5-FU): 600 mg\u002Fm² continuous infusion during 22hours at D1 and D2, every 14 days during 42 months (8 cycles).",[20,13],"Drug: Chemotherapy in regimen with Oxaliplatin, fluorouracil, folinic acid (FOLFOX4)",[22,28,33,37],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"RADIATION","Radiotherapy 50 Gy","Radiotherapy 50 Gy 5 radiations per week of 2 Gy for 5 weeks",[9],null,{"type":29,"name":30,"description":31,"armGroupLabels":32,"otherNames":27},"DRUG","Fluorouracil\u002Ffolic acid","Fluorouracil 400 mg\u002Fm² D1-4 and folic acid 20mg\u002Fm2 D1-4 the first and fifth weeks of radiotherapy",[9],{"type":29,"name":34,"description":35,"armGroupLabels":36,"otherNames":27},"Chemotherapy in regimen with Oxaliplatin, fluorouracil, folinic acid (FOLFOX4)","oxaliplatin: 85 mg\u002Fm² in 2 hours at D1; folinic acid: 100 mg\u002Fm² simultaneously in 2 hours at D1 and D2 during the Oxaliplatin; bolus 5-fluorouracil (5-FU) 400mg\u002Fm² D1+D2; infusion 5-fluorouracil (5-FU): 600 mg\u002Fm² continuous infusion during 22hours at D1 and D2, every 14 days during 42 months (8 cycles).",[16],{"type":23,"name":24,"description":38,"armGroupLabels":39,"otherNames":27},"Chemoradiotherapy 5 weeks (50 Grays (Gy), 2 Gy\u002Fsession; 25 fractions) + fluorouracil\u002Fleucovorin 400 mg\u002Fm² 1-4 day the first and fifth weeks of radiotherapy.\n\nFOLOFX4 will be administrated for 8 cycles over a 16 week period. Patients will undergo re-staging within 6 weeks of their 8th cycle of FOLFOX. This will include MRI of the pelvis. If the reassessment reveals that there has been no disease progression compared to the pre-treatment evaluation and the patient remains a candidate for an R0 resection, the patient will proceed to definitive rectal cancer surgery within 8 weeks from the last chemotherapy dose. If the surgical oncologist's reassessment reveals that the patient is not a candidate for an R0 resection, the patient will proceed to standard pre-operative radiation with synchronous fluorouracil.",[16],[41],{"name":42,"role":43,"phone":44,"phoneExt":27,"email":45},"Rita Ambraziene","CONTACT","+37037326196","rita.ambraziene@gmail.com",[47],{"facility":42,"status":48,"city":49,"state":27,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"RECRUITING","Kaunas","45304","Lithuania","LT",{"type":54,"coordinates":55},"Point",[56,57],23.90909,54.90156,{"lat":57,"lon":56},[60,62,64,67,69,72,74,76,78,80],{"name":42,"role":43,"phone":61,"phoneExt":27,"email":45},"837326196",{"name":27,"role":43,"phone":27,"phoneExt":63,"email":45},"Ambraziene",{"name":65,"role":66,"phone":27,"phoneExt":27,"email":27},"Rita Ambraziene, MD","PRINCIPAL_INVESTIGATOR",{"name":68,"role":66,"phone":27,"phoneExt":27,"email":27},"Rasa Jančiauskienė, prof",{"name":70,"role":71,"phone":27,"phoneExt":27,"email":27},"Tadas Latkauskas, prof","SUB_INVESTIGATOR",{"name":73,"role":71,"phone":27,"phoneExt":27,"email":27},"Laimonas Jaruševičius, assoc.prof",{"name":75,"role":71,"phone":27,"phoneExt":27,"email":27},"Algimantas Tamelis, prof",{"name":77,"role":71,"phone":27,"phoneExt":27,"email":27},"Žilvinas Saladžinskas, prof",{"name":79,"role":71,"phone":27,"phoneExt":27,"email":27},"Irina Gineikienė, phd",{"name":81,"role":71,"phone":27,"phoneExt":27,"email":27},"Ingrida Pikūnienė, MD",{"type":66,"investigatorFullName":42,"investigatorTitle":83,"investigatorAffiliation":5,"oldNameTitle":27,"oldOrganization":27},"Sub-Investigator","100468372","phase-2-neoadjuvant-therapy-vs-standard-therapy-in-locally-advanced-rectal-cancer-100468372",false,"NCT05378919","Neoadjuvant Therapy vs Standard Therapy in Locally Advanced Rectal Cancer","Evaluation and Comparison of the Efficacy of a New Standard Pre-operative Chemotherapy for Stage II and III Colorectal Cancer According to the FOLFOX4 Regimen With Routine Chemoradiation Therapy","RECTUM2015","Inclusion Criteria:\n\n* diagnosed with rectal adenocarcinoma;\n* radiologically measurable tumor size;\n* general condition (ECOG 0-2 points);\n* stage II or III rectal tumor clinically (pelvic MRI and endorectal ultrasound),\n* in the absence of long-term spread of the disease (confirmed by radiological examinations (computed tomography of the thorax and abdomen));\n* during preoperative proctoscopy, the tumor is detected 0 -15 cm from the anus;\n* Blood tests 28 days before the start of treatment:\n\nand general blood count: neutrophils greater than 1.5x10 9 \u002F l, platelets greater than 100 x 10 9 \u002F l, Hemoglobin greater than 80 g \u002F l, liver enzymes (Aspartate aminotransferase (AST\u002FGOT), alanine aminotransferase (ALT\u002FGPT) not more than 3 times upper limit), and renal function (creatinine up to 1.5 times the upper limit of normal) is normal; women of childbearing potential - negative pregnancy test;\n\n• A signed informed consent form.\n\nExclusion Criteria:\n\n* patients with signs of intestinal obstruction at the start of treatment;\n* previous lower abdominal radiation therapy;\n* other tumors over a five-year period;\n* pregnant or breastfeeding women;\n* men and women of childbearing potential who do not agree to use adequate contraception;\n* Patient co-morbidities that would make the patient unsuitable for this study or significantly interfere with the assessment of safety and toxicity.","ALL","18 Years",{"count":95,"type":96},250,"ESTIMATED","INTERVENTIONAL",[99],"PHASE2","Phase II, Multicenter, Open-label, Randomized Study evaluating neoadjuvant chemotherapy (FOLFOX4) in patients with stage II and III colorectal cancer with standard chemoradiation Defined by Magnetic Resonance Imaging",[102],"Neoadjuvant Therapy in Rectal Cancer, Radiotherapy, FOLFOX","2022-05-12",{"date":105,"type":106},"2022-05-18","ACTUAL",{"date":108,"type":106},"2015-06-01",{"date":110,"type":96},"2027-06-01",{"name":5,"class":6},1]