[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100565489":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":28,"centralContacts":96,"locations":107,"responsibleParty":147,"collaborators":149,"id":197,"slug":198,"hasResults":199,"nctId":200,"briefTitle":201,"officialTitle":202,"acronym":203,"eligibilityCriteria":204,"healthyVolunteers":199,"sex":205,"minAge":206,"maxAge":207,"enrollmentInfo":208,"targetDuration":101,"studyType":211,"phases":212,"briefSummary":214,"conditions":215,"keywords":101,"overallStatus":110,"whyStopped":101,"lastUpdateSubmitDate":217,"lastUpdatePostDateStruct":218,"startDateStruct":221,"completionDateStruct":223,"leadSponsor":225,"locationsCount":226},{"fullName":5,"class":6},"University Hospital, Tours","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Experimental: Group A","EXPERIMENTAL","Patients randomized to the experimental group of the trial will receive bevacizumab as an IV infusion at a dose of 10 mg\u002Fkg, administered in 2 preparations of 5 mg\u002Fkg, every 2 weeks. Patients will receive treatment until progression, patient refusal, or unacceptable toxicity.",[13],"Drug: Avastin, 25 Mg\u002FmL Intravenous Solution",{"label":15,"type":16,"description":17,"interventionNames":18},"Active comparator: Group B","ACTIVE_COMPARATOR","Patients randomized to the control group of the trial will receive bevacizumab at a dose of 5 mg\u002Fkg and placebo (NaCl) every two weeks. Patients will receive treatment until progression, patient refusal, or unacceptable toxicity.",[13],[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Avastin, 25 Mg\u002FmL Intravenous Solution","Experimental group\u002F Patients randomized to the experimental group of the trial will receive bevacizumab as an IV infusion at a dose of 10 mg\u002Fkg, administered in 2 preparations of 5 mg\u002Fkg, every 2 weeks. Patients will receive treatment until progression, patient refusal, or unacceptable toxicity.\n\nControl group: Patients randomized to the control group of the trial will receive bevacizumab at a dose of 5 mg\u002Fkg and placebo (NaCl) every two weeks. Patients will receive treatment until progression, patient refusal, or unacceptable toxicity.",[15,9],[26,27],"Experimental group","Control group",[29,33,36,39,42,45,48,51,54,57,60,63,66,69,72,75,78,81,84,87,90,93],{"name":30,"affiliation":31,"role":32},"Christophe Borg","Besançon, FRANCE","PRINCIPAL_INVESTIGATOR",{"name":34,"affiliation":35,"role":32},"Michel Ducreux","Gustave Roussy, FRANCE",{"name":37,"affiliation":38,"role":32},"Caroline Petorin","Clermont-Ferrand, FRANCE",{"name":40,"affiliation":41,"role":32},"Olivier Bouché","Reims, FRANCE",{"name":43,"affiliation":44,"role":32},"Jean-Philippe Metges","Brest, FRANCE",{"name":46,"affiliation":47,"role":32},"Jean-Baptiste Bachet","Pitié- Salpétrière, FRANCE",{"name":49,"affiliation":50,"role":32},"Frédéric Di Fiore","Rouen, FRANCE",{"name":52,"affiliation":53,"role":32},"David Tougeron","Poitiers, FRANCE",{"name":55,"affiliation":56,"role":32},"Astrid Lièvre","Rennes, FRANCE",{"name":58,"affiliation":59,"role":32},"Rosine Guimbaud","Toulouse , FRANCE",{"name":61,"affiliation":62,"role":32},"Thomas Aparicio","St Louis , FRANCE",{"name":64,"affiliation":65,"role":32},"Thomas Walter","Edouard Hériot, FRANCE",{"name":67,"affiliation":68,"role":32},"Côme Lepage","Dijon, FRANCE",{"name":70,"affiliation":71,"role":32},"Yann Touchefeu","Nantes, FRANCE",{"name":73,"affiliation":74,"role":32},"Vincent Hautefeuille","Amiens, FRANCE",{"name":76,"affiliation":77,"role":32},"Pascal Artru","Jean Mermoz, FRANCE",{"name":79,"affiliation":80,"role":32},"Christophe Tournigand","Henri Mondor, France",{"name":82,"affiliation":83,"role":32},"Pascal Hammel","Paul Brousse, FRANCE",{"name":85,"affiliation":86,"role":32},"Romain Desgrippes","St-Malo, FRANCE",{"name":88,"affiliation":89,"role":32},"Philippe Laplaige","Blois, FRANCE",{"name":91,"affiliation":92,"role":32},"Karine Bouhier-Leporrier","Caen, FRANCE",{"name":94,"affiliation":95,"role":32},"Marie Muller","Nancy, france",[97,103],{"name":98,"role":99,"phone":100,"phoneExt":101,"email":102},"Thierry Lecomte","CONTACT","0247475900",null,"thierry.lecomte@med.univ-tours.fr",{"name":104,"role":99,"phone":105,"phoneExt":101,"email":106},"Adeline MOUSSET","0218370645","a.fourmy@chu-tours.fr",[108,123,131,137],{"facility":109,"status":110,"city":111,"state":101,"zip":101,"country":112,"countryCode":113,"cosmosGeoPoint":114,"geoPoint":119,"contacts":120},"BORG","RECRUITING","Besançon","France","FR",{"type":115,"coordinates":116},"Point",[117,118],6.01815,47.24878,{"lat":118,"lon":117},[121],{"name":122,"role":99,"phone":101,"phoneExt":101,"email":101},"CHRISTOPHE BORG",{"facility":37,"status":124,"city":125,"state":101,"zip":101,"country":112,"countryCode":113,"cosmosGeoPoint":126,"geoPoint":130,"contacts":101},"NOT_YET_RECRUITING","Clermont-Ferrand",{"type":115,"coordinates":127},[128,129],3.08682,45.77969,{"lat":129,"lon":128},{"facility":132,"status":124,"city":133,"state":101,"zip":101,"country":112,"countryCode":113,"cosmosGeoPoint":101,"geoPoint":101,"contacts":134},"Ducreux","Gustave Roussy",[135],{"name":136,"role":99,"phone":101,"phoneExt":101,"email":101},"DUVREUX MICHEL",{"facility":52,"status":110,"city":138,"state":101,"zip":101,"country":112,"countryCode":113,"cosmosGeoPoint":139,"geoPoint":143,"contacts":144},"Poitiers",{"type":115,"coordinates":140},[141,142],0.34348,46.58261,{"lat":142,"lon":141},[145],{"name":146,"role":99,"phone":101,"phoneExt":101,"email":101},"DAVID TOUGERON",{"type":148,"investigatorFullName":101,"investigatorTitle":101,"investigatorAffiliation":101,"oldNameTitle":101,"oldOrganization":101},"SPONSOR",[150,153,155,157,159,161,163,165,167,169,171,173,175,177,179,181,183,185,187,189,191,193,195],{"name":151,"class":152},"CHU DE BESANCON","UNKNOWN",{"name":154,"class":6},"Gustave Roussy, Cancer Campus, Grand Paris",{"name":156,"class":6},"University Hospital, Clermont-Ferrand",{"name":158,"class":6},"CHU de Reims",{"name":160,"class":152},"CHU de Brest",{"name":162,"class":6},"Pitié-Salpêtrière Hospital",{"name":164,"class":6},"University Hospital, Rouen",{"name":166,"class":6},"Poitiers University Hospital",{"name":168,"class":6},"Institut Paoli-Calmettes",{"name":170,"class":6},"Rennes University Hospital",{"name":172,"class":6},"University Hospital, Toulouse",{"name":174,"class":152},"AP-HP, Hôpital Saint-Louis",{"name":176,"class":152},"HCL Hôpital Edouard Hériot",{"name":178,"class":6},"Centre Hospitalier Universitaire Dijon",{"name":180,"class":6},"Nantes University Hospital",{"name":182,"class":6},"Centre Hospitalier Universitaire, Amiens",{"name":184,"class":152},"Hôpital Privé Jean Mermoz",{"name":186,"class":152},"AP-HP, Hôpital Henri Mondor",{"name":188,"class":6},"Hopital Paul Brousse",{"name":190,"class":152},"CHG de St-Malo",{"name":192,"class":152},"Polyclinique de Blois",{"name":194,"class":6},"University Hospital, Caen",{"name":196,"class":6},"Central Hospital, Nancy, France","100565489","phase-3-bevacizumab-based-chemotherapy-adapted-to-bevacizumab-pharmacokinetics-in-1st-line-treatment-100565489",false,"NCT06642844","Bevacizumab-based Chemotherapy Adapted to Bevacizumab Pharmacokinetics in 1st-line Treatment","Bevacizumab-based Chemotherapy Tailored to the Pharmacokinetics of Bevacizumab in First-line Treatment of Unresectable Metastatic Colorectal Cancer: a Randomized, Multicenter, Double-blind Phase 3 Study","PHARBEVACOL","Inclusion Criteria:\n\n* Patients aged ≥18 years.\n* Histologically proven metastatic colorectal adenocarcinoma (on primary tumor and\u002For metastases) inoperable, well documented, i.e. not compatible with complete oncological resection at inclusion.\n* For whom treatment with bevacizumab is indicated.\n* For women of childbearing age: effective contraception.\n* ECOG Performance status (PS) 0-2.\n* No prior treatment of metastatic disease (in the case of adjuvant treatment, interval between the end of chemotherapy and relapse \\> 6 months if fluoropyrimidine alone or \\> 12 months if FOLFOX).\n* At least one evaluable or measurable lesion assessed by computed tomography (CT) according to RECIST v1.1 criteria.\n* Life expectancy greater than 3 months.\n* Adequate hematological, renal and hepatic biological parameters: neutrophils ≥ 1.5x109\u002FL; platelets ≥ 100x109\u002FL; hemoglobin ≥ 9 g\u002FdL; serum creatinine \\\u003C150 μmol\u002FL; bilirubinemia ≤ 1.5 x upper limit of normal (ULN), alkaline phosphatase \\\u003C 5xULN; proteinuria \\\u003C 2+ (urine dipstick) or ≤ 1 g\u002F24h.\n* Written informed consent signed by the patient.\n* Patient affiliated to a French social security system.\n\nRandomization criteria in the experimental phase:\n\n\\- Serum concentration of bevacizumab on D14 ≤ 15.5 mg\u002FL (measured just before the 2nd infusion of bevacizumab).\n\nExclusion Criteria:\n\nLess than 6 months from the end of any prior chemotherapy, radiotherapy or adjuvant surgery.\n\n* Patient with a known non-indication or contraindication to first-line chemotherapy based on bevacizumab.\n* Cardiovascular contraindication to the prescription of bevacizumab: heart failure, cardiovascular event within 6 months, NYHA ≥ 2 (New York Heart Association), poorly controlled arterial hypertension, history of hypertensive crisis or hypertensive encephalopathy; Grade 3\u002F4 anterior venous thromboembolism (NCI-CTCAE)\n* Inadequate hematological, hepatic and renal function\n* Urine test strip for proteinuria ≥ 2+ unless proteinuria \\\u003C 1 g \u002F 24 hours is demonstrated.\n* Current or recent (within 10 days of study enrollment) use of aspirin (\\>325 mg\u002Fday) or clopidogrel (\\>75 mg\u002Fday).\n* Current or recent use (within 10 days before the first dose of bevacizumab) of oral or parenteral therapeutic anticoagulants or thrombolytic agents for therapeutic purposes.\n* Untreated CNS metastases or treatment of brain metastases, either by surgical or radiological techniques, must have been completed more than 4 weeks before the first study treatment.\n* Surgical procedure (including open biopsy, surgical resection, wound revision, or other major surgery involving entry into a body cavity) or significant traumatic injury within 28 days prior to study enrollment or anticipation of study need for major surgery during the study.\n* Serious non-healing wound, active ulcer or untreated bone fracture.\n* Other neoplasias (previous or current), except:\n\n  * i\u002F carcinoma in situ of the cervix adequately treated,\n  * ii\u002F basal cell or squamous cell carcinoma of the skin,\n  * iii\u002F cancer in complete remission for more than 5 years.\n* Other illnesses, which, according to the doctor, are life-threatening to the patient and\u002For which are uncontrolled.\n* Primary tumor in place and symptomatic (occlusion, hemorrhage).\n* Pregnant or breastfeeding women.\n* Patients unable to give consent.\n* Patients under guardianship, curatorship or legal protection.","ALL","18 Years","99 Years",{"count":209,"type":210},244,"ESTIMATED","INTERVENTIONAL",[213],"PHASE3","Bevacizumab is a standard drug for metastatic colorectal cancer (mCRC) in combination with cytotoxic chemotherapy. However, inter-individual pharmacokinetic variability was observed for bevacizumab and an exposure-response relationship for efficacy was described for bevacizumab in mCRC patients treated with 1st-line bevacizumab-based chemotherapy.",[216],"Unresectable Metastatic Colorectal Cancer","2026-06-12",{"date":219,"type":220},"2026-06-16","ACTUAL",{"date":222,"type":220},"2025-03-04",{"date":224,"type":210},"2029-03-04",{"name":5,"class":6},4]