[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658928":3},{"organization":4,"outcomesModule":7,"designInfo":14,"detailedDescription":20,"studyPopulation":13,"armGroups":21,"interventions":29,"overallOfficials":44,"centralContacts":49,"locations":54,"responsibleParty":71,"collaborators":13,"id":73,"slug":74,"hasResults":75,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":13,"eligibilityCriteria":79,"healthyVolunteers":75,"sex":80,"minAge":81,"maxAge":13,"enrollmentInfo":82,"targetDuration":13,"studyType":85,"phases":86,"briefSummary":88,"conditions":89,"keywords":13,"overallStatus":91,"whyStopped":13,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":101},{"fullName":5,"class":6},"M.D. Anderson Cancer Center","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":13},[9],{"measure":10,"description":11,"timeFrame":12},"Safety and Adverse Events (AEs)","Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 6.0","Through study completion; an average of 1 year",null,{"allocation":15,"interventionModel":16,"interventionModelDescription":13,"primaryPurpose":17,"observationalModel":13,"timePerspective":13,"maskingInfo":18},"NA","SINGLE_GROUP","SUPPORTIVE_CARE",{"masking":19,"maskingDescription":13,"whoMasked":13},"NONE","Primary Objective:\n\nTo evaluate whether low-dose colchicine (0.6 mg orally once daily for 24 months) reduces radiation-induced carotid vascular injury compared to placebo in survivors of head and neck cancer who have completed curative-intent radiotherapy, as assessed by a hierarchical composite endpoint analyzed using the win ratio method, comprising: (1) time to death; (2) time to TIA, CVA, or ischemic heart disease; (3) time to carotid artery stenosis \\>50%; and (4) change in carotid intima-media thickness (CIMT) from pre-radiotherapy baseline to 24 months postrandomization.\n\nSecondary Objective:\n\nEfficacy\n\n1. To evaluate the effect of colchicine on each individual component of the primary hierarchical composite endpoint.\n2. To assess carotid plaque development, progression, and regression by serial duplex ultrasound.\n3. To characterize longitudinal CIMT trajectory from pre-radiotherapy baseline through the 24-month intervention period using all available imaging timepoints.\n4. To evaluate carotid artery volume change from pre-radiotherapy baseline to month 24.\n\n   Safety and tolerability\n5. To evaluate the safety and tolerability of low-dose colchicine in HNC survivors, with adverse events graded per CTCAE v6.0.\n6. To assess study medication adherence.\n7. To assess the rate of locoregional and distant cancer recurrence during the study period.\n\n   Exploratory and correlative\n8. To determine whether baseline SASP-related circulating biomarkers (GAGome, serum glutamate, H₂S) and CHIP status predict RICAD risk and treatment response to colchicine.\n9. To evaluate ALDH2 expression and 4-HNE adduct levels in PBMCs as pharmacodynamic markers of colchicine target engagement.\n10. To assess whether the baseline NAA index refines RICAD risk stratification beyond traditional cardiovascular risk factors.\n11. To develop a clinical decision support tool integrating baseline clinical characteristics, 3D dosimetry, and carotid imaging to predict adverse carotid outcomes following RT.",[22],{"label":23,"type":24,"description":25,"interventionNames":26},"Double- blind Treatment with Colchicine or Placebo","EXPERIMENTAL","Treatment will be administeredon an outpatient basis",[27,28],"Drug: Colchicine","Other: Placebo",[30,40],{"type":31,"name":32,"description":33,"armGroupLabels":34,"otherNames":35},"DRUG","Colchicine","0.6 mg given by mouth once daily for 24 months",[23],[36,37,38,39],"Colcrys","Mitigare","Gloperba","Lodoco",{"type":6,"name":41,"description":42,"armGroupLabels":43,"otherNames":13},"Placebo","Given by mouth once daily for 24 months",[23],[45],{"name":46,"affiliation":47,"role":48},"Efstratios Koutroumpakis, MD","UT MD Anderson","PRINCIPAL_INVESTIGATOR",[50],{"name":46,"role":51,"phone":52,"phoneExt":13,"email":53},"CONTACT","(713) 563-5439","ekoutroumpakis@mdanderson.org",[55],{"facility":47,"status":13,"city":56,"state":57,"zip":58,"country":59,"countryCode":60,"cosmosGeoPoint":61,"geoPoint":66,"contacts":67},"Houston","Texas","77030","United States","US",{"type":62,"coordinates":63},"Point",[64,65],-95.36327,29.76328,{"lat":65,"lon":64},[68,70],{"name":46,"role":51,"phone":69,"phoneExt":13,"email":53},"713-563-5439",{"name":46,"role":48,"phone":13,"phoneExt":13,"email":13},{"type":72,"investigatorFullName":13,"investigatorTitle":13,"investigatorAffiliation":13,"oldNameTitle":13,"oldOrganization":13},"SPONSOR","100658928","phase-2-a-ph2-colchicine-for-inflammatory-carotid-injury-and-disease-evolution-after-radiotherapy-100658928",false,"NCT07856719","A Ph2, Colchicine For Inflammatory Carotid Injury And Disease Evolution After Radiotherapy","COINCIDE-RT: A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Single-Center Trial Of Low-Dose Colchicine For The Prevention Of Radiation-Induced Carotid Artery Disease In Survivors Of Head And Neck Cancer (Colchicine For Inflammatory Carotid Injury And Disease Evolution After Radiotherapy [COINCIDE-RT])","Inclusion Criteria:\n\n* Adults aged ≥18 years.\n* Clinical diagnosis of head and neck cancer (HNC), including malignancies of the oral cavity, oropharynx, hypopharynx, larynx, nasopharynx, or salivary glands.\n* Receipt of curative-intent radiotherapy to the neck, completed ≤18 months prior to randomization.\n* No evidence of locoregional or distant disease recurrence, confirmed by standard-of-care imaging at 3-6 months post-RT completion as documented by the treating head and neck radiation oncologist. Participants must not be scheduled to receive additional cancerdirected systemic or radiation therapy during the study period.\n* ECOG performance status ≤2.\n* For women of childbearing potential (WOCBP): negative serum or urine pregnancy test within 7 days prior to randomization and agreement to use adequate contraception for the duration of study treatment and for at least 30 days following the last dose of study drug. WOCBP is defined as any female between the onset of menses and 55 years of age unless an applicable exclusionary factor is present (postmenopausal ≥12 consecutive months without menses; history of hysterectomy or bilateral salpingo-oophorectomy; history of bilateral tubal ligation or other surgical sterilization). Approved methods of contraception include hormonal contraception (oral, injectable, implantable, transdermal, or vaginal ring), intrauterine device (IUD), and barrier methods (condom plus spermicide). Periodic abstinence and the rhythm method are not acceptable. (Refer to MD Anderson Institutional Policy #CLN1114.) Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.\n* Male participants must agree to use adequate contraception for the duration of study treatment, given the potential effects of colchicine on spermatogenesis through microtubule inhibition.\n* Ability to understand and willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n* Palliative or non-curative intent radiotherapy.\n* Known carotid artery stenosis ≥50% at baseline screening.\n* Prior history of radiotherapy to the neck (other than the qualifying course of RT for this study), carotid artery dissection, or prior carotid revascularization (endarterectomy or stenting).\n* Known hypersensitivity or prior intolerance to colchicine.\n* Current chronic use of colchicine for any other indication.\n* Severe renal impairment (eGFR \\\u003C30 mL\u002Fmin\u002F1.73 m² by CKD-EPI equation) or end-stage renal disease requiring dialysis.\n* Severe hepatic impairment (Child-Turcotte-Pugh class C).\n* Pre-existing significant blood dyscrasia, defined as absolute neutrophil count \\\u003C1,500 cells\u002Fmm³ or platelet count \\\u003C50,000 cells\u002Fmm³.\n* Concurrent requirement for strong CYP3A4 inhibitors (e.g., clarithromycin, itraconazole, cyclosporine) or P-glycoprotein (P-gp) inhibitors that cannot be discontinued for the duration of study treatment. A list of prohibited concomitant medications is provided in Appendix A.\n* History of peripheral neuritis, myositis, or clinically significant myopathy attributed to statin therapy.\n* Chronic systemic corticosteroid use for any ongoing medical condition.\n* Pregnancy, breastfeeding, or expressed intent to become pregnant during the study period.\n* Concurrent enrollment in another clinical trial with an active interventional treatment arm.\n* Psychiatric illness or social circumstances that would limit compliance with study requirements or follow-up.\n* Any condition that, in the opinion of the investigator, would prevent protocol adherence or compromise participant safety","ALL","18 Years",{"count":83,"type":84},250,"ESTIMATED","INTERVENTIONAL",[87],"PHASE2","The goal of this clinical research study is to find out if low-dose colchicine (an anti-inflammatory drug) lowers the rate of radiation-related side effects to the carotid artery in patients who have completed radiation therapy for head and neck cancer.",[90],"Head and Neck Cancer","NOT_YET_RECRUITING","2026-09-29",{"date":94,"type":95},"2026-10-05","ACTUAL",{"date":97,"type":84},"2027-03-01",{"date":99,"type":84},"2034-07-01",{"name":5,"class":6},1]