rtog-0813

RTOG0813,VersionDateJune8,2015NRGONCOLOGYRTOG0813SEAMLESSPHASEI/IISTUDYOFSTEREOTACTICLUNGRADIOTHERAPY(SBRT)FOREARLYSTAGE,CENTRALLYLOCATED,NON-SMALLCELLLUNGCANCER(NSCLC)INMEDICALLYINOPERABLEPATIENTSLimitedParticipationStudy:SeeSection5.0StudyTeam(6/8/15)PrincipalInvestigator/RadiationOncologyFormerMedicalPhysicsCo-ChairAndreaBezjak,MDLechPapiez,PhDPrincessMargaretHospital/UniversityofTorontoTheIndianaUniversityCyclotronFacility610UniversityAvenueToronto,CanadaM5G-2M9416-946-2132/[e-mail]-ChairComorbidityCo-ChairJeffreyBradley,MDElizabethGore,MDWashingtonUniversitySchoolofMedicineMedicalCollegeofWisconsin4921ParkviewPlace9200WestWisconsinAvenueSt.Louis,MO63110Milwaukee,WI53226314-362-4633/FAX[phone]/[e-mail]@radonc.mcw.eduRadiationOncologyCo-ChairTranslationalResearchCo-ChairLaurieGaspar,MDFeng-Ming(Spring)PhoenixKong,MD,PhDUniversityofColoradoDenverGeorgiaRegentsUniv.CancerCenter1665AuroraCt.,Ste1032,MailStopF-706821St.SebastianWay,HK112Aurora,CO80045Augusta,GA30912720-848-0154/FAX[phone]/[e-mail]@gru.eduSBRTCo-ChairRobertD.Timmerman,M.D.UniversityofTexasSouthwestern5801ForestParkRoad,NF3.302BDallas,TX75390-9183214-645-7651/[e-mail]OG0813,VersionDateJune8,2015RTOG0813TitlePage(Continued)[8/7/12]SeniorStatisticianConsultingStatisticianChenHu,PhDDanielNormolle,PhDNRGOncologyUniversityofPittsburgh/UPCIBiostatisticsFacility1818MarketStreet,Suite1720201N.CraigStreet/SterlingPlaza,Suite325Philadelphia,PA19103Pittsburgh,PA15213215-940-4842FAX[phone]/[e-mail][e-mail]n/UpdateDateBroadcastDateAmendment7June8,2015June22,2015Amendment6March6,2014March19,2014ClosureSeptember5,2013September5,2013UpdateAugust7,2012August7,2012Amendment5July23,2012July30,2012UpdateApril12,2012April12,2012Amendment4February9,2011February17,2011Amendment3August20,2010September30,2010Amendment2July27,2010September30,2010Amendment1February16,2010February28,2010UpdateMay7,2009May7,2009UpdateFebruary2,2009February2,2009ActivationFebruary2,2009February2,2009RTOGHeadquarters1-800-227-5463,ext.4189ThisprotocolwasdesignedanddevelopedbytheRadiationTherapyOncologyGroup(RTOG)oftheAmericanCollegeofRadiology(ACR).Itisintendedtobeusedonlyinconjunctionwithinstitution-specificIRBapprovalforstudyentry.NootheruseorreproductionisauthorizedbyRTOGnordoesRTOGassumeanyresponsibilityforunauthorizeduseofthisprotocol.RTOG0813,VersionDateJune8,2015INDEXSchemaEligibilityChecklist1.0Introduction2.0Objectives3.0PatientSelection4.0PretreatmentEvaluations/Management5.0RegistrationProcedures6.0RadiationTherapy7.0DrugTherapy8.0Surgery9.0OtherTherapy10.0Tissue/SpecimenSubmission11.0PatientAssessments12.0DataCollection13.0StatisticalConsiderationsReferencesAppendixI-SampleConsentFormAppendixII-StudyParametersAppendixIII-PerformanceStatusScoringAppendixIV-StagingSystemAppendixV-ComorbidityRecordingSheetandCharlsonComorbidityIndex(CCI)AppendixVI-SpecimenCollectionInstructionsAppendixVII-TimingofDLTsDuringtheFirstYearinTwoCompletedRTOGLungTrialsRTOG0813,VersionDateJune8,2015NRGONCOLOGYRTOG0813SeamlessPhaseI/IIStudyofStereotacticLungRadiotherapy(SBRT)forEarlyStage,CentrallyLocated,Non-SmallCellLungCancer(NSCLC)inMedicallyInoperablePatientsSCHEMAEscalatingdoselevels;atalllevels,patientswillreceiveq2dayfractionationX5fractionsover1.5-2weeksDoseLevelLevel1Level2Level3Level4†Level5Level6Level7Level8Level9DoseperFraction8Gy8.5Gy9Gy9.5Gy10Gy10.5Gy11Gy11.5Gy12GyTotalDose40Gy42.5Gy45Gy47.5Gy50Gy52.5Gy55Gy57.5Gy60Gy†ProtocoltreatmentbeginsatLevel5.Levels1-4willbeemployedifdose-limitingtoxicityisseenwiththeLevel5(10Gy)startingdose.SeeSection5.0forpre-registrationrequirements;seeSection6.0fordetailsofradiationtherapyplanninganddelivery.ALLSITESNOTE:(3/6/14)Immediatelyuponidentificationofaseriousadverseevent(SAE)asdefinedinSection13.1.1,thesitewilltelephonethe24-hourRTOGAEReportLine:215-717-2762.ThesitewillprovidedetailsoftheSAEtoRTOGHeadquartersandwillbeinstructedtofaxthecompletedlungadverseeventform(AE),FAX:[phone],within24hoursofdiscoveryoftheadverseevent.TheAEformisavailableontheRTOGwebsite,withallofthe0813-specificforms(willbeonwebsitepriortoactivationofstudy).ThesitealsowillreporttheadverseeventviaCTEP-AERS(seeSection6.10).AllsitesmustfaxtheTreatmentChart(T5)toRTOGHeadquarters(215-940-8831;Attn:RTQA)onthelastdayofthepatient’streatmentorbytheendofthenextbusinessday(seeSection12.1).PatientPopulation:(SeeSection3.0forEligibility)PatientswithstageT1-2,N0,M0,non-smallcelllungcancer,tumorsize≤5cm,whoarenotcandidatesforacompletesurgicalresectionintheopinionofathoracicsurgeon;onlypatientswithtumorswithinortouchingthezoneoftheproximalbronchialtreeoradjacenttomediastinalorpericardialpleura(seeSection3.1.5fordetails).RequiredSampleSize:110(7/23/12)RTOG0813,VersionDateJune8,2015RTOGInstitution#RTOG0813ELI