2025
Eligibility Criteria in Advanced Urothelial Cancer Clinical Trials: An Assessment of Modernization and Inclusion
Mercier B, Govindarajan A, Castro D, Li X, Philip E, Feng M, Prajapati S, Chan E, Lee K, Sehgal I, Patel J, O'Dell A, Chehrazi‐Raffle A, Ebrahimi H, Rock A, Zengin Z, Meza L, Dizman N, Hsu J, Liu S, Dorff T, Pal S, Tripathi A. Eligibility Criteria in Advanced Urothelial Cancer Clinical Trials: An Assessment of Modernization and Inclusion. Cancer Medicine 2025, 14: e70696. PMID: 40145383, PMCID: PMC11947756, DOI: 10.1002/cam4.70696.Peer-Reviewed Original ResearchConceptsHepatitis B/C infectionHIV infectionClinical trialsConcurrent malignancyBrain metastasesVariant histologyEligibility criteriaPresence of brain metastasesAmerican Society of Clinical OncologyMetastatic urothelial cancerFisher's exact testType of therapyContemporary clinical trialsFriends of Cancer ResearchInclusion of patientsUrothelial cancerExact testClinical OncologyTherapy efficacyCancer clinical trialsCancer trialsHIVPatientsExclusion criteriaInfectionThe role of regional and practice trial sites in nonrepresentative randomized cancer trial enrollment
Shah S, Manz C, Balthis B, Raman H, Abaluck J, Keating N, Agha L. The role of regional and practice trial sites in nonrepresentative randomized cancer trial enrollment. Journal Of The National Cancer Institute 2025, djaf071. PMID: 40108483, DOI: 10.1093/jnci/djaf071.Peer-Reviewed Original ResearchSEER-Medicare cohortBlack patientsCohort of peoplePrevalence of ageDrug trial participationCancer trialsPatient-level dataRural patientsTrial recruitmentRural residentsSEER-MedicareTrial participantsTrial enrollmentRepresentative trialsEnrolling patientsRenal cancerUnder-enrolledCancer treatmentPatientsEnrollmentPracticeTrialsCancerTrial sitesDisparities
2024
Integrating 4 Methods (In4M) to evaluate physical function in patients with cancer: Results of a comprehensive digital health study.
Thanarajasingam G, Dueck A, Bhatnagar V, Brown A, Cathcart-Rake E, Diamond M, Faust L, Fiero M, Huntington S, Jeffery M, Jones L, Paludo J, Power B, Ross J, Ruddy K, Schellhorn S, Tarver M, Wood W, Gross C, Kluetz P. Integrating 4 Methods (In4M) to evaluate physical function in patients with cancer: Results of a comprehensive digital health study. Journal Of Clinical Oncology 2024, 42: 1564-1564. DOI: 10.1200/jco.2024.42.16_suppl.1564.Peer-Reviewed Original ResearchPhysical functionPF measuresDaily stepsClinically meaningful change scoresAverage daily stepsEvaluate physical functionDigital health studiesMeasures of PFWearable dataHealth StudyWalk testWeekend daysCore outcomeChange scoresPerformance statusTreatment toleranceDetect changesPearson correlationECOG performance statusBreast cancerEvaluate feasibilityCancer trialsSignificant declineData collectionBaseline
2023
Treatment efficacy score: a better surrogate for arm-level survival differences in neoadjuvant breast cancer trials?
Chehayeb R, Kahn A, Pusztai L. Treatment efficacy score: a better surrogate for arm-level survival differences in neoadjuvant breast cancer trials? Future Oncology 2023, 19: 1945-1951. PMID: 37767612, DOI: 10.2217/fon-2022-1203.Peer-Reviewed Original ResearchExcellent long-term survivalNeoadjuvant breast cancer trialsResidual cancer burden scorePathologic complete responseBreast cancer trialsLong-term survivalNeoadjuvant chemotherapyPathologic responseComplete responseSurvival improvementBurden scoreResidual diseaseTrial armsSurvival differencesCancer trialsBreast cancerTreatment efficacyStage IIGood surrogateEfficacy scoresTrialsSurvivalScoresRate differencesChemotherapyRepresentativeness of Patients Enrolled in the Lung Cancer Master Protocol (Lung-MAP)
Vaidya R, Unger J, Qian L, Minichiello K, Herbst R, Gandara D, Neal J, Leal T, Patel J, Dragnev K, Waqar S, Edelman M, Sigal E, Adam S, Malik S, Blanke C, LeBlanc M, Kelly K, Gray J, Redman M. Representativeness of Patients Enrolled in the Lung Cancer Master Protocol (Lung-MAP). JCO Precision Oncology 2023, 7: e2300218. PMID: 37677122, PMCID: PMC10581630, DOI: 10.1200/po.23.00218.Peer-Reviewed Original ResearchConceptsCharacteristics of patientsLung-MAPMaster protocolsNSCLC populationCell lung cancer trialsSEER registry dataPatients 65 yearsPrecision medicine clinical trialsPatient exclusion criteriaLung cancer trialsRepresentativeness of patientsMedicine clinical trialsNSCLC trialsOlder patientsMedicaid/More patientsSubgroup analysisCancer trialsClinical trialsVulnerable patientsRegistry dataExclusion criteriaPatientsNSCLC studiesSociodemographic characteristicsAssessment of eligibility criteria in advanced urothelial cancer (aUC) trials based on ASCO-FCR recommendations.
Castro D, Feng M, Prajapati S, Chan E, Lee K, Sehgal I, Patel J, O'Dell A, Zengin Z, Li X, Chehrazi-Raffle A, Dizman N, Tripathi A, Rock A, Liu S, Mercier B, Meza L, Philip E, Dorff T, Pal S. Assessment of eligibility criteria in advanced urothelial cancer (aUC) trials based on ASCO-FCR recommendations. Journal Of Clinical Oncology 2023, 41: 453-453. DOI: 10.1200/jco.2023.41.6_suppl.453.Peer-Reviewed Original ResearchHIV positivityHCV positivityEligibility criteriaCancer trialsExclusion criteriaConcurrent malignancyBrain metastasesCombination therapyExact testClass of therapyTrial eligibility criteriaReal-world populationFisher's exact testRestrictive eligibility criteriaSpecific study populationMultiple cancer typesChemotherapy trialsReal-world practiceInvestigational treatmentStudy populationRadiation therapyClinical OncologyPrognostic toolTherapySignificant associationEvaluation of eligibility criteria in contemporary renal cell carcinoma based on ASCO-FCR recommendations.
Prajapati S, Feng M, Castro D, Lee K, Chan E, Sehgal I, Patel J, O'Dell A, Zengin Z, Li X, Chehrazi-Raffle A, Dizman N, Tripathi A, Rock A, Liu S, Mercier B, Meza L, Philip E, Dorff T, Pal S. Evaluation of eligibility criteria in contemporary renal cell carcinoma based on ASCO-FCR recommendations. Journal Of Clinical Oncology 2023, 41: 612-612. DOI: 10.1200/jco.2023.41.6_suppl.612.Peer-Reviewed Original ResearchRestrictive eligibility criteriaEligibility criteriaHCV positivityHIV positivityInclusion criteriaExclusion criteriaExact testClass of therapyReal-world populationRenal cell carcinomaFisher's exact testChi-square testConcurrent malignancyBrain metastasesAdult patientsCell carcinomaCombination therapyPatient populationCancer trialsRCC trialsConsensus statementRadiation therapyClinical OncologyPrognostic toolReal-world setting
2022
Improving Cancer Care for Patients With CKD: The Need for Changes in Clinical Trials
Sprangers B, Perazella MA, Lichtman SM, Rosner MH, Jhaveri KD. Improving Cancer Care for Patients With CKD: The Need for Changes in Clinical Trials. Kidney International Reports 2022, 7: 1939-1950. PMID: 36090489, PMCID: PMC9458993, DOI: 10.1016/j.ekir.2022.06.005.Peer-Reviewed Original ResearchChronic kidney diseaseEnd-stage kidney diseaseSevere kidney dysfunctionKidney diseaseKidney dysfunctionAdvanced kidney diseaseOptimal clinical careCancer drug trialsNumber of patientsNarrow therapeutic indexInitial clinical studiesKidney replacement treatmentPreregistration studiesKidney functionCancer careReplacement treatmentCancer trialsClinical trialsEffective dosingClinical studiesTreatment decisionsDrug trialsBeneficial drugsClinical carePatientsRepresentativeness of patients enrolled in the Lung Cancer Master Protocol (Lung-MAP).
Vaidya R, Unger J, Qian L, Minichiello K, Herbst R, Gandara D, Neal J, Leal T, Patel J, Dragnev K, Waqar S, Edelman M, Sigal E, Adam S, Malik S, Blanke C, LeBlanc M, Kelly K, Redman M. Representativeness of patients enrolled in the Lung Cancer Master Protocol (Lung-MAP). Journal Of Clinical Oncology 2022, 40: 6543-6543. DOI: 10.1200/jco.2022.40.16_suppl.6543.Peer-Reviewed Original ResearchLung-MAPRepresentativeness of patientsNSCLC populationMaster protocolsNSCLC trialsMedicaid/National Clinical Trials NetworkNon-small cell lung cancer trialsSquamous cell lung cancerEnd Results registry dataNovel therapeuticsCell lung cancer trialsCell lung cancerLung cancer trialsClinical Trials NetworkNeighborhood socioeconomic deprivationArea-level measuresOlder patientsMore patientsHispanic patientsRural patientsTrial participationLung cancerTrial findingsCancer trialsFirst in Human Phase 1/2 ICONIC Trial of the ICOS agonist vopratelimab alone and with nivolumab: ICOS high CD4 T cell populations and predictors of response
Yap TA, Gainor JF, Callahan MK, Falchook GS, Pachynski RK, LoRusso P, Kummar S, Gibney GT, Burris HA, Tykodi SS, Rahma OE, Seiwert TY, Papadopoulos KP, Murphy M, Park H, Hanson A, Hashambhoy-Ramsay Y, McGrath L, Hooper E, Xiao X, Cohen H, Fan M, Felitsky D, Hart C, McComb R, Brown K, Sepahi A, Jimenez J, Zhang W, Baeck J, Laken H, Murray R, Trehu E, Harvey CJ. First in Human Phase 1/2 ICONIC Trial of the ICOS agonist vopratelimab alone and with nivolumab: ICOS high CD4 T cell populations and predictors of response. Clinical Cancer Research 2022, 28: 3695-3708. PMID: 35511938, PMCID: PMC9433959, DOI: 10.1158/1078-0432.ccr-21-4256.Peer-Reviewed Original ResearchConceptsSubset of patientsPredictive biomarkersPharmacodynamic biomarkersModest objective response rateNon-small cell lung cancer trialsCD4 T cell populationCell lung cancer trialsPhase IObjective response ratePhase II doseAdvanced solid tumorsCD4 T cellsFavorable safety profilePotential predictive biomarkersLung cancer trialsPredictors of responseT cell populationsGreater clinical benefitClinical outcomesClinical benefitSafety profileCancer trialsNivolumabT cellsPatientsTreatment Efficacy Score—continuous residual cancer burden-based metric to compare neoadjuvant chemotherapy efficacy between randomized trial arms in breast cancer trials
Marczyk M, Mrukwa A, Yau C, Wolf D, Chen Y, Balassanian R, Nanda R, Parker B, Krings G, Sattar H, Zeck J, Albain K, Boughey J, Liu M, Elias A, Clark A, Venters S, Shad S, Basu A, Asare S, Buxton M, Asare A, Rugo H, Perlmutter J, DeMichele A, Yee D, Berry D, Veer L, Symmans W, Esserman L, Pusztai L, Consortium I. Treatment Efficacy Score—continuous residual cancer burden-based metric to compare neoadjuvant chemotherapy efficacy between randomized trial arms in breast cancer trials. Annals Of Oncology 2022, 33: 814-823. PMID: 35513244, DOI: 10.1016/j.annonc.2022.04.072.Peer-Reviewed Original ResearchConceptsTrial armsExperimental armSurvival differencesExact testPathologic complete response rateClinical trial armsI-SPY2 trialNeoadjuvant chemotherapy efficacyComplete response rateBreast cancer trialsCytotoxic efficacyFisher's exact testImpact of treatmentNeoadjuvant chemotherapyPCR ratePathologic responseResidual cancerControl cohortCancer trialsAssessed associationsChemotherapy efficacyEarly surrogateOlaparib armResponse rateHigher cytotoxic efficacy
2021
Consensus Guidelines for the Definition of Time-to-Event End Points in Image-guided Tumor Ablation: Results of the SIO and DATECAN Initiative
Puijk R, Ahmed M, Adam A, Arai Y, Arellano R, de Baère T, Bale R, Bellera C, Binkert C, Brace C, Breen D, Brountzos E, Callstrom M, Carrafiello G, Chapiro J, de Cobelli F, Coupé V, Crocetti L, Denys A, Dupuy D, Erinjeri J, Filippiadis D, Gangi A, Gervais D, Gillams A, Greene T, Guiu B, Helmberger T, Iezzi R, Kang T, Kelekis A, Kim H, Kröncke T, Kwan S, Lee M, Lee F, Lee E, Liang P, Lissenberg-Witte B, Lu D, Madoff D, Mauri G, Meloni M, Morgan R, Nadolski G, Narayanan G, Newton I, Nikolic B, Orsi F, Pereira P, Pua U, Rhim H, Ricke J, Rilling W, Salem R, Scheffer H, Sofocleous C, Solbiati L, Solomon S, Soulen M, Sze D, Uberoi R, Vogl T, Wang D, Wood B, Goldberg S, Meijerink M. Consensus Guidelines for the Definition of Time-to-Event End Points in Image-guided Tumor Ablation: Results of the SIO and DATECAN Initiative. Radiology 2021, 301: 533-540. PMID: 34581627, DOI: 10.1148/radiol.2021203715.Peer-Reviewed Original ResearchConceptsImage-guided tumor ablationTime-to-event end pointsEnd pointsTumor ablationOncologic end pointsOncological outcome measuresOutcome measuresPatient-reported outcome questionnairesClinical outcome measuresInterventional oncologyConsensus guidelinesClinical trialsHealth economic issuesCancer trialsQuality of lifeConsensus documentOutcomes QuestionnaireDATECANAssess outcomesReport outcomesOncology researchInternational panelTrialsAblationOutcomes
2020
The value of interventional radiology in clinical trial teams: experience from the BATTLE lung cancer trials
Tam AL, Papadimitrakopoulou V, Wistuba II, Lee JJ, Ensor JE, Kim ES, Kalhor N, Blumenschein GR, Tsao AS, Heymach JV, Herbst RS, Hicks ME, Hong WK, Gupta S. The value of interventional radiology in clinical trial teams: experience from the BATTLE lung cancer trials. Clinical Radiology 2020, 76: 155.e25-155.e34. PMID: 33268083, DOI: 10.1016/j.crad.2020.09.024.Peer-Reviewed Original ResearchConceptsInterventional radiologistsClinical trial teamsTrial teamPercutaneous image-guided biopsyLung Cancer EliminationLung cancer trialsEvidence of viabilityImage-guided biopsyLesion scoring systemBiomarker analysisCancer trialsTargeted therapyCancer eliminationScore's abilityInterventional radiologyMultivariate analysisLesionsBiopsySolid massFollowing criteriaModerate agreementMultidisciplinary approachTrialsScoresBiomarkersIncreasing accrual of minority patients in breast cancer clinical trials
Trant AA, Walz L, Allen W, DeJesus J, Hatzis C, Silber A. Increasing accrual of minority patients in breast cancer clinical trials. Breast Cancer Research And Treatment 2020, 184: 499-505. PMID: 32840699, DOI: 10.1007/s10549-020-05873-2.Peer-Reviewed Original ResearchConceptsClinical trialsHispanic patientsCancer CenterEligibility criteriaWhite patientsMinority patientsYale Cancer CenterBreast cancer clinical trialsConnecticut Tumor RegistryLiver function testsBreast cancer trialsCancer clinical trialsParticipation of patientsClinical Trials OfficeGrand rounds presentationTumor RegistryCenter patientsFunction testsChronic conditionsCancer trialsPatient educationPatientsTrials InitiativeTrials OfficeHealthcare providers
2017
Cost-Effectiveness of Thoracic Radiation Therapy for Extensive-Stage Small Cell Lung Cancer Using Evidence From the Chest Radiotherapy Extensive-Stage Small Cell Lung Cancer Trial (CREST)
Patrice G, Lester-Coll N, Yu J, Amdahl J, Delea T, Patrice S. Cost-Effectiveness of Thoracic Radiation Therapy for Extensive-Stage Small Cell Lung Cancer Using Evidence From the Chest Radiotherapy Extensive-Stage Small Cell Lung Cancer Trial (CREST). International Journal Of Radiation Oncology • Biology • Physics 2017, 100: 97-106. PMID: 29029885, DOI: 10.1016/j.ijrobp.2017.08.041.Peer-Reviewed Original ResearchConceptsExtensive-stage small cell lung cancerThoracic radiation therapyProgression-free survivalIncremental cost-effectiveness ratioExtensive-stage small cell lung cancer patientsSmall cell lung cancerCell lung cancerStandard treatmentLung cancer trialsRadiation therapyOverall survivalLung cancerUS health care payer perspectiveLong-term survival benefitCancer trialsFavorable incremental cost-effectiveness ratiosProgressive metastatic diseaseHealth care payer perspectiveProportion of patientsBase-case analysisFollow-up intervalCost-effectiveness ratioMetastatic diseasePostprogression survivalPayer perspectiveMoving forward with actionable therapeutic targets and opportunities in endometrial cancer: NCI clinical trials planning meeting report on identifying key genes and molecular pathways for targeted endometrial cancer trials
MacKay HJ, Levine DA, Bae-Jump VL, Bell DW, McAlpine JN, Santin A, Fleming GF, Mutch DG, Nephew KP, Wentzensen N, Goodfellow PJ, Dorigo O, Nijman HW, Broaddus R, Kohn EC. Moving forward with actionable therapeutic targets and opportunities in endometrial cancer: NCI clinical trials planning meeting report on identifying key genes and molecular pathways for targeted endometrial cancer trials. Oncotarget 2017, 5: 84579-84594. PMID: 29137450, PMCID: PMC5663622, DOI: 10.18632/oncotarget.19961.Peer-Reviewed Original ResearchEndometrial cancerClinical trialsEndometrial cancer managementEndometrial cancer trialsFuture clinical trialsActionable therapeutic targetsNCI clinical trialsNational Cancer InstituteHistologic stratificationCancer trialsCancer managementCancer InstituteMortality rateTherapeutic targetTherapeutic directionsNew drugsCancerMolecular pathwaysTrialsMeeting reportSteering CommitteeActionable opportunitiesGroup of expertsKey genesIncidenceGlobal cancer pain management: a systematic review comparing trials in Africa, Europe and North America
Odonkor CA, Kim G, Erdek M. Global cancer pain management: a systematic review comparing trials in Africa, Europe and North America. Pain Management 2017, 7: 299-310. PMID: 28699421, DOI: 10.2217/pmt-2016-0047.Peer-Reviewed Original ResearchConceptsCancer pain managementPain managementQuality of studiesQuality assessment toolAdjuvant therapyPain trialsJadad scoreCare indexCancer trialsCochrane methodsEligible studiesStudy qualityStudy sample sizeCancer survivorshipSystematic reviewAbstractTextTrialsAssessment toolReviewLiterature reviewSample sizeOpioidsAntidepressantsTherapyManagement
2016
Accrual of Older Patients With Breast Cancer to Alliance Systemic Therapy Trials Over Time: Protocol A151527
Freedman RA, Foster JC, Seisler DK, Lafky JM, Muss HB, Cohen HJ, Mandelblatt J, Winer EP, Hudis CA, Partridge AH, Carey LA, Cirrincione C, Moreno-Aspitia A, Kimmick G, Jatoi A, Hurria A. Accrual of Older Patients With Breast Cancer to Alliance Systemic Therapy Trials Over Time: Protocol A151527. Journal Of Clinical Oncology 2016, 35: 421-431. PMID: 27992272, PMCID: PMC5455700, DOI: 10.1200/jco.2016.69.4182.Peer-Reviewed Original ResearchConceptsOlder patientsMetastatic trialsAdjuvant trialsBreast cancerHormone receptor-negative tumorsBreast cancer treatment trialConclusion Older patientsSystemic therapy trialsReceptor-negative tumorsBreast cancer trialsCancer treatment trialsYears of ageAccrual challengesNeoadjuvant trialsAdjuvant studiesPatient ageTherapy cessationLymph nodesTherapeutic trialsTreatment cessationTumor sizeDisease characteristicsPatient populationTreatment trialsCancer trials
2015
A retrospective analysis of RET translocation, gene copy number gain and expression in NSCLC patients treated with vandetanib in four randomized Phase III studies
Platt A, Morten J, Ji Q, Elvin P, Womack C, Su X, Donald E, Gray N, Read J, Bigley G, Blockley L, Cresswell C, Dale A, Davies A, Zhang T, Fan S, Fu H, Gladwin A, Harrod G, Stevens J, Williams V, Ye Q, Zheng L, de Boer R, Herbst RS, Lee JS, Vasselli J. A retrospective analysis of RET translocation, gene copy number gain and expression in NSCLC patients treated with vandetanib in four randomized Phase III studies. BMC Cancer 2015, 15: 171. PMID: 25881079, PMCID: PMC4412099, DOI: 10.1186/s12885-015-1146-8.Peer-Reviewed Original ResearchConceptsGene copy number gainCopy number gainsRET rearrangementsTumor samplesComparator armVandetanib treatmentNumber gainRandomized phase III studyPhase III clinical trialsCell lung cancer trialsObjective response ratePhase III studyLung cancer trialsRET protein expressionNSCLC subpopulationVandetanib armRadiologic evidenceIII studyNSCLC patientsObjective responseTumor shrinkageComparator drugsCancer trialsClinical trialsRetrospective analysis
2014
The KRAS-Variant and miRNA Expression in RTOG Endometrial Cancer Clinical Trials 9708 and 9905
Lee LJ, Ratner E, Uduman M, Winter K, Boeke M, Greven KM, King S, Burke TW, Underhill K, Kim H, Boulware RJ, Yu H, Parkash V, Lu L, Gaffney D, Dicker AP, Weidhaas J. The KRAS-Variant and miRNA Expression in RTOG Endometrial Cancer Clinical Trials 9708 and 9905. PLOS ONE 2014, 9: e94167. PMID: 24732316, PMCID: PMC3986055, DOI: 10.1371/journal.pone.0094167.Peer-Reviewed Original ResearchConceptsEndometrial cancer riskType 2 endometrial cancerEndometrial cancerKRAS-variantCancer riskLymphovascular invasionSurvival outcomesTumor biologyType 1 endometrial cancerEndometrial cancer trialsOverall survival rateMiRNA expressionAge-matched controlsCase-control analysisFunctional germline variantsClinical characteristicsPatient ageTumor characteristicsCancer trialsTumor specimensSurvival rateType 1Germline variantsMiRNA expression levelsCancer
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