[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100416431":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":41,"responsibleParty":409,"collaborators":26,"id":411,"slug":412,"hasResults":413,"nctId":414,"briefTitle":415,"officialTitle":416,"acronym":417,"eligibilityCriteria":418,"healthyVolunteers":413,"sex":419,"minAge":420,"maxAge":26,"enrollmentInfo":421,"targetDuration":26,"studyType":424,"phases":425,"briefSummary":427,"conditions":428,"keywords":432,"overallStatus":44,"whyStopped":26,"lastUpdateSubmitDate":437,"lastUpdatePostDateStruct":438,"startDateStruct":441,"completionDateStruct":443,"leadSponsor":445,"locationsCount":446},{"fullName":5,"class":6},"Hospices Civils de Lyon","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"PCV alone","EXPERIMENTAL","Administration of 6 cycles of PCV chemotherapy alone.",[13],"Drug: PCV chemotherapy",{"label":15,"type":16,"description":17,"interventionNames":18},"RT + PCV","ACTIVE_COMPARATOR","Radiotherapy followed by administration of PCV chemotherapy.",[19],"Drug: Radiotherapy and PCV chemotherapy",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","PCV chemotherapy","1. cycle of PCV chemotherapy is given as:\n\n   * Day 1: CCNU 110 mg\u002Fm2 orally;\n   * Days 8 and 29: Vincristine 1.4 mg\u002Fm2 IV;\n   * Days 8 to 21: Procarbazine 60 mg\u002Fm2 orally\n\n6 cycles are given.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Radiotherapy and PCV chemotherapy","Radiotherapy will deliver 50.4 Gy in 28 fractions of 1.8 Gy using IMRT technique.\n\nFollowed by 6 cycles of PCV chemotherapy\n\n1 cycle of PCV is given as:\n\n* Day 1: CCNU 110 mg\u002Fm2 orally;\n* Days 8 and 29: Vincristine 1.4 mg\u002Fm2 IV;\n* Days 8 to 21: Procarbazine 60 mg\u002Fm2 orally",[15],[32,37],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},"François DUCRAY, MD, PhD","CONTACT","+33(0) 4 72 35 78 06","francois.ducray@chu-lyon.fr",{"name":38,"role":34,"phone":39,"phoneExt":26,"email":40},"Cécile TROUBA","+33(0) 4 72 35 69 15","cecile.trouba@chu-lyon.fr",[42,60,74,88,102,118,133,147,161,175,189,203,217,231,245,259,270,284,298,312,326,339,353,367,381,395],{"facility":43,"status":44,"city":45,"state":26,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"CHU d'Amiens-Picardie Site Sud","RECRUITING","Amiens","80054","France","FR",{"type":50,"coordinates":51},"Point",[52,53],2.3,49.9,{"lat":53,"lon":52},[56],{"name":57,"role":34,"phone":58,"phoneExt":26,"email":59},"Mathieu BOONE, MD","03 22 45 54 99","Boone.mathieu@chu-amiens.fr",{"facility":61,"status":44,"city":62,"state":26,"zip":63,"country":47,"countryCode":48,"cosmosGeoPoint":64,"geoPoint":68,"contacts":69},"Institut de Cancerologie de l'Ouest","Angers","49055",{"type":50,"coordinates":65},[66,67],-0.55202,47.47156,{"lat":67,"lon":66},[70],{"name":71,"role":34,"phone":72,"phoneExt":26,"email":73},"Paule AUGEREAU, MD","02 41 35 27 00","paule.augereau@ico.unicancer.fr",{"facility":75,"status":44,"city":76,"state":26,"zip":77,"country":47,"countryCode":48,"cosmosGeoPoint":78,"geoPoint":82,"contacts":83},"CHU de Bordeaux Hôpital Saint André","Bordeaux","33075",{"type":50,"coordinates":79},[80,81],-0.58046,44.84124,{"lat":81,"lon":80},[84],{"name":85,"role":34,"phone":86,"phoneExt":26,"email":87},"Charlotte BRONNIMANN, MD","05 56 79 58 08","charlotte.bronnimann@chu-bordeaux.fr",{"facility":89,"status":44,"city":90,"state":26,"zip":91,"country":47,"countryCode":48,"cosmosGeoPoint":92,"geoPoint":96,"contacts":97},"Institut de Cancérologie et Hematologie (ICH) - CHRU Brest, Hopital Morvan","Brest","29200",{"type":50,"coordinates":93},[94,95],-4.48628,48.39029,{"lat":95,"lon":94},[98],{"name":99,"role":34,"phone":100,"phoneExt":26,"email":101},"Benjamin AUBERGER, MD","02 98 22 33 95","benjamin.auberger@chu-brest.fr",{"facility":5,"status":44,"city":103,"state":26,"zip":104,"country":47,"countryCode":48,"cosmosGeoPoint":105,"geoPoint":109,"contacts":110},"Bron","69500",{"type":50,"coordinates":106},[107,108],4.91303,45.73865,{"lat":108,"lon":107},[111,114,116],{"name":33,"role":34,"phone":112,"phoneExt":113,"email":36},"4 72 35 78 06","+33",{"name":38,"role":34,"phone":115,"phoneExt":113,"email":40},"4 72 35 69 15",{"name":33,"role":117,"phone":26,"phoneExt":26,"email":26},"PRINCIPAL_INVESTIGATOR",{"facility":119,"status":120,"city":121,"state":26,"zip":122,"country":47,"countryCode":48,"cosmosGeoPoint":123,"geoPoint":127,"contacts":128},"CHU de 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Colmar","Colmar","68024",{"type":50,"coordinates":152},[153,154],7.35584,48.08078,{"lat":154,"lon":153},[157],{"name":158,"role":34,"phone":159,"phoneExt":26,"email":160},"Guido AHLE, MD","03 89 12 41 54","guido.ahle@ch-colmar.fr",{"facility":162,"status":120,"city":163,"state":26,"zip":164,"country":47,"countryCode":48,"cosmosGeoPoint":165,"geoPoint":169,"contacts":170},"Centre Georges Francois Leclerc","Dijon","21000",{"type":50,"coordinates":166},[167,168],5.01391,47.31344,{"lat":168,"lon":167},[171],{"name":172,"role":34,"phone":173,"phoneExt":26,"email":174},"François GHIRINGHELLI, MD","03 80 73 75 06","FGhiringhelli@cgfl.fr",{"facility":176,"status":44,"city":177,"state":26,"zip":178,"country":47,"countryCode":48,"cosmosGeoPoint":179,"geoPoint":183,"contacts":184},"Hôpital Roger Salengro CHU de Lille","Lille","59037",{"type":50,"coordinates":180},[181,182],3.05512,50.63391,{"lat":182,"lon":181},[185],{"name":186,"role":34,"phone":187,"phoneExt":26,"email":188},"Apolline MONFILLIETTE, MD","03 20 44 66 21","apolline.djelad@chru-lille.fr",{"facility":190,"status":120,"city":191,"state":26,"zip":192,"country":47,"countryCode":48,"cosmosGeoPoint":193,"geoPoint":197,"contacts":198},"CHU de Limoges","Limoges","87042",{"type":50,"coordinates":194},[195,196],1.24759,45.83362,{"lat":196,"lon":195},[199],{"name":200,"role":34,"phone":201,"phoneExt":26,"email":202},"Elise DELUCHE, MD","05 55 05 61 00","elise.deluche@chu-limoges.fr",{"facility":204,"status":120,"city":205,"state":26,"zip":206,"country":47,"countryCode":48,"cosmosGeoPoint":207,"geoPoint":211,"contacts":212},"Centre Léon Bérard","Lyon","69008",{"type":50,"coordinates":208},[209,210],4.84789,45.74906,{"lat":210,"lon":209},[213],{"name":214,"role":34,"phone":215,"phoneExt":26,"email":216},"Alice BONNEVILLE-LEVARD, MD","04 69 16 66 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93","atessier@ch-annecygenevois.fr",{"facility":285,"status":44,"city":286,"state":26,"zip":287,"country":47,"countryCode":48,"cosmosGeoPoint":288,"geoPoint":292,"contacts":293},"Centre Eugène Marquis","Rennes","35042",{"type":50,"coordinates":289},[290,291],-1.67431,48.11109,{"lat":291,"lon":290},[294],{"name":295,"role":34,"phone":296,"phoneExt":26,"email":297},"Elodie VAULEON, MD","02 99 25 31 82","e.vauleon@rennes.unicancer.fr",{"facility":299,"status":44,"city":300,"state":26,"zip":301,"country":47,"countryCode":48,"cosmosGeoPoint":302,"geoPoint":306,"contacts":307},"Centre Henri Becquerel","Rouen","76038",{"type":50,"coordinates":303},[304,305],1.09932,49.44313,{"lat":305,"lon":304},[308],{"name":309,"role":34,"phone":310,"phoneExt":26,"email":311},"Maxime FONTANILLES, MD","02 32 08 22 39","maxime.fontanilles@chb.unicancer.fr",{"facility":313,"status":120,"city":314,"state":26,"zip":315,"country":47,"countryCode":48,"cosmosGeoPoint":316,"geoPoint":320,"contacts":321},"CHU Saint-Etienne","Saint-Etienne","42055",{"type":50,"coordinates":317},[318,319],4.39,45.43389,{"lat":319,"lon":318},[322],{"name":323,"role":34,"phone":324,"phoneExt":26,"email":325},"Carole RAMIREZ, MD","06 62 13 37 01","carole.ramirez@chu-st-etienne.fr",{"facility":61,"status":44,"city":327,"state":26,"zip":328,"country":47,"countryCode":48,"cosmosGeoPoint":329,"geoPoint":333,"contacts":334},"Saint-Herblain","44805",{"type":50,"coordinates":330},[331,332],-1.651,47.21154,{"lat":332,"lon":331},[335],{"name":336,"role":34,"phone":337,"phoneExt":26,"email":338},"Carole GOURMELON, MD","02 40 67 99 00","carole.gourmelon@ico.unicancer.fr",{"facility":340,"status":44,"city":341,"state":26,"zip":342,"country":47,"countryCode":48,"cosmosGeoPoint":343,"geoPoint":347,"contacts":348},"Centre de Lutte Contre le Cancer PAUL STRAUSS","Strasbourg","67200",{"type":50,"coordinates":344},[345,346],7.74553,48.58392,{"lat":346,"lon":345},[349],{"name":350,"role":34,"phone":351,"phoneExt":26,"email":352},"Georges NOEL, MD, PhD","03 88 25 24 71","gnoel@icans.eu",{"facility":354,"status":120,"city":355,"state":26,"zip":356,"country":47,"countryCode":48,"cosmosGeoPoint":357,"geoPoint":361,"contacts":362},"Hôpital Foch","Suresnes","92150",{"type":50,"coordinates":358},[359,360],2.22929,48.87143,{"lat":360,"lon":359},[363],{"name":364,"role":34,"phone":365,"phoneExt":26,"email":366},"Nadia Younan, MD","01 46 25 25 25","n.younan@hopital-foch.com",{"facility":368,"status":120,"city":369,"state":26,"zip":370,"country":47,"countryCode":48,"cosmosGeoPoint":371,"geoPoint":375,"contacts":376},"Institut Universitaire du Cancer Toulouse Oncopole","Toulouse","31059",{"type":50,"coordinates":372},[373,374],1.44367,43.60426,{"lat":374,"lon":373},[377],{"name":378,"role":34,"phone":379,"phoneExt":26,"email":380},"Elizabeth MOYAL, MD, PhD","05 31 15 54 45","moyal.elizabeth@iuct-oncopole.fr",{"facility":382,"status":120,"city":383,"state":26,"zip":384,"country":47,"countryCode":48,"cosmosGeoPoint":385,"geoPoint":389,"contacts":390},"CHRU de Tours","Tours","37044",{"type":50,"coordinates":386},[387,388],0.70398,47.39484,{"lat":388,"lon":387},[391],{"name":392,"role":34,"phone":393,"phoneExt":26,"email":394},"Ilyess ZEMMOURA, MD, PhD","02 18 37 08 13","ilyess.zemmoura@univ-tours.fr",{"facility":396,"status":120,"city":397,"state":26,"zip":398,"country":47,"countryCode":48,"cosmosGeoPoint":399,"geoPoint":403,"contacts":404},"Gustave Roussy","Villejuif","94805",{"type":50,"coordinates":400},[401,402],2.35992,48.7939,{"lat":402,"lon":401},[405],{"name":406,"role":34,"phone":407,"phoneExt":26,"email":408},"Sarah DUMONT, MD","01 42 11 62 20","sarah.dumont@gustaveroussy.fr",{"type":410,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100416431","phase-3-a-randomized-trial-of-delayed-radiotherapy-in-patients-low-grade-oligodendrogliomas-requiring-a-treatment-other-than-surgery-100416431",false,"NCT04702581","A Randomized Trial of Delayed Radiotherapy in Patients Low-grade Oligodendrogliomas Requiring a Treatment Other Than Surgery","A Randomized Trial of Delayed Radiotherapy in Patients 1p\u002F19q Codeleted Low-grade Oligodendrogliomas Requiring a Treatment Other Than Surgery","POLO","Inclusion Criteria:\n\n* Tumor is co-deleted for 1p and 19q based and IDH-mutant (IDH1 or IDH2) according to local diagnosis\n* Histological confirmation of low-grade oligodendroglioma by central pathological review according to WHO 2016 classification\n* Age ≥ 18 years\n* Patients with one or several prior surgical procedure for a low-grade oligodendroglioma and who undergo a resurgery are eligible if they have not received prior radiotheray or chemotherapy and if the last histological diagnosis is a low-grade oligodendroglioma prior use of specific HDI prohibitions is permitted\n* Patients who undergo an initial follow-up after surgery or re-surgery are eligible if there is no evidence of anaplastic transformation on MRI (no new contrast enhancement, no obvious modification of the growth rate)\n* Patients requiring an oncological treatment other than surgery because of one or more of the following characteristics:\n\n  * Progressive disease defined as documented growth prior to inclusion\n  * Symptomatic disease defined as the presence of neurological or cognitive symptoms or refractory seizures defined as having both persistent seizures interfering with everyday life activities other than driving a car and three lines of anti-epileptic drug regimen had not worked, including at least one combination regimen.\n  * Age ≥ 40 and any surgical therapy\n  * Age \\\u003C 40 with prior and subtotal resection or biopsy (i.e., anything less than gross total resection)\n* Willing and able to complete neurocognitive examination and the QOL\n* Karnofsky performance status ≥ 60\n* Laboratory values obtained between 21 days before inclusion andrandomization, respecting the following criteria:\n* Absolute neutrophil count (ANC) ≥1500 \u002Fmm3\n* Platelet count ≥100,000 \u002F mm3\n* Hemoglobin \\> 9.0 g\u002FdL\n* Total bilirubin ≤ 1.5 x upper limit of normal (ULN)\n* SGOT (AST) ≤ 3 x ULN\n* Negative serum or urine pregnancy test done ≤ 7 days prior to registration, for women of childbearing potential only.\n* Provide informed written consent\n\nExclusion Criteria:\n\n* Pregnant and nursing women\n* Men or women of childbearing potential who are unwilling to employ adequate contraception for up to 6 months following the completion of PCV.\n* Received any prior radiation therapy or chemotherapy for any CNS neoplasm.\n* Co-morbid systemic illnesses or other severe concurrent disease which would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens.\n* Concomitant serious immunocompromised status (other than that related to concomitant steroids).\n* Uncontrolled intercurrent illness or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n* Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm (except specific inhibitors of IDH)\n* Other active malignancy within 5 years of registration. Exceptions: Non-melanotic skin cancer or carcinoma-in-situ of the cervix.\n* Contra-indication to CCNU: hypersensitivity to CCNU, wheat allergy, association to yellow fever vaccin\n* Contra-indication to Procarbazine: severe renal failure, severe hepatic failure, hypersensitivity to procarbazine, association to yellow fever vaccin\n* Contra-indication to Vincristine: hypersensitivity to vincristine, neuromuscular disorder (for example demyelinating Charcot-Mary Tooth neuropathy), severe renal failure, severe hepatic failure.\n* Not depending from the french system of health assurance","ALL","18 Years",{"count":422,"type":423},280,"ESTIMATED","INTERVENTIONAL",[426],"PHASE3","Because of their prolonged survival, patients with 1p\u002F19q-codeleted low-grade oligodendrogliomas treated with RT + PCV are at risk of neurocognitive deterioration. We make the hypothesis that withholding radiotherapy until tumor progression could reduce the risk of neurocognitive deterioration without impairing overall survival.",[429,430,431],"Oligodendroglioma","Low-grade Oligodendroglioma","1p19q Codeletion",[433,434,435,436],"low-grade oligodendroglioma","radiotherapy","PCV","neurocognitive deterioration","2026-01-28",{"date":439,"type":440},"2026-01-29","ACTUAL",{"date":442,"type":440},"2021-12-07",{"date":444,"type":423},"2030-12",{"name":5,"class":6},26]