[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100609145":3},{"organization":4,"outcomesModule":7,"designInfo":28,"detailedDescription":11,"studyPopulation":11,"armGroups":35,"interventions":42,"overallOfficials":11,"centralContacts":47,"locations":54,"responsibleParty":71,"collaborators":11,"id":75,"slug":11,"hasResults":76,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":11,"eligibilityCriteria":80,"healthyVolunteers":76,"sex":81,"minAge":82,"maxAge":11,"enrollmentInfo":83,"targetDuration":11,"studyType":86,"phases":87,"briefSummary":88,"conditions":89,"keywords":11,"overallStatus":91,"whyStopped":11,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":101},{"fullName":5,"class":6},"British Columbia Cancer Agency","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":11},[9],{"measure":10,"description":11,"timeFrame":12},"Assess 2-year orbital LC after 12 Gy in 6 fractions.",null,"24 Months after Treatment",[14,17,20,23,26],{"measure":15,"description":11,"timeFrame":16},"Response rates (complete\u002Fpartial\u002Fminimal response, stable\u002Fprogressive disease)","6 months and 12 months after treatment",{"measure":18,"description":11,"timeFrame":19},"Evaluate orbital local control","5 years after treatment",{"measure":21,"description":11,"timeFrame":22},"Assess freedom from further in-field RT (FFRT), freedom from distant relapse (FFDR) and overall survival (OS)","2 year and 5 year after treatment",{"measure":24,"description":25,"timeFrame":19},"Health-Related Quality of Life using the EORTC QLQ-C30","The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC QLQ-C30) measures health-related quality of life through 5 functional, 9 symptom, and 1 global health status scale; minimum score = 0, maximum score = 100 (for functional scales, higher is better; for symptom scales, lower is better)",{"measure":27,"description":11,"timeFrame":22},"Ocular Toxicity per CTCAE (5.0)",{"allocation":29,"interventionModel":30,"interventionModelDescription":31,"primaryPurpose":32,"observationalModel":11,"timePerspective":11,"maskingInfo":33},"NA","SINGLE_GROUP","12 Gy in 6 fractions external beam radiotherapy using standard-of-care radiation volumes for low-grade orbital lymphoma.","TREATMENT",{"masking":34,"maskingDescription":11,"whoMasked":11},"NONE",[36],{"label":37,"type":38,"description":39,"interventionNames":40},"12 Gy in 6 fractions of external beam radiation therapy","EXPERIMENTAL","12 Gy in 6 fractions of conventional external beam radiation therapy using standard-of-care radiation volumes for low-grade orbital lymphoma",[41],"Radiation: External Beam Radiation Therapy",[43],{"type":44,"name":45,"description":37,"armGroupLabels":46,"otherNames":11},"RADIATION","External Beam Radiation Therapy",[37],[48],{"name":49,"role":50,"phone":51,"phoneExt":52,"email":53},"Sandy Chang","CONTACT","604-675-4100","202199","sandy.chang@bccancer.bc.ca",[55],{"facility":56,"status":11,"city":57,"state":58,"zip":59,"country":60,"countryCode":61,"cosmosGeoPoint":62,"geoPoint":67,"contacts":68},"BC Cancer Vancouver","Vancouver","British Columbia","V5Z4E6","Canada","CA",{"type":63,"coordinates":64},"Point",[65,66],-123.11934,49.24966,{"lat":66,"lon":65},[69],{"name":49,"role":50,"phone":70,"phoneExt":52,"email":53},"6048776000",{"type":72,"investigatorFullName":73,"investigatorTitle":74,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"PRINCIPAL_INVESTIGATOR","Matthew Chan","Principal Investigator (Co-PI)","100609145",false,"NCT07210749","Radiotherapy 12Gy in 6 Fractions For Orbital Lymphoma","A Phase II Trial Assessing 12 Gy in 6 Fractions Radiotherapy for Low-Grade B-cell Orbital Lymphoma","Inclusion Criteria:\n\n* Age ≥18 years with stage I-IV indolent NHL\\*\n* Able to provide informed consent\n* Histologically confirmed indolent NHL involving one or both orbits. If bilateral, biopsy of only one orbit is permitted as long as high clinical suspicion of contralateral orbit involvement\n* Measurable orbital disease after biopsy, either clinically or radiographically\n* ECOG performance status 0-3\n* Life expectancy \\>12 months\n* Available for treatment and follow-up (including scheduled post-treatment imaging and ophthalmologic exam)\n* Able and willing to complete quality of life questionnaires via paper or online portal if they provide their email address on the informed consent document\n\n  * Stage II-IV allowed but if systemic therapy given after RT the timing will be recorded, and subjects will be stratified according to receipt of systemic therapy\n\nExclusion Criteria:\n\n* Aggressive NHL histology (including grade 3B follicular lymphoma)\n* Prior RT to orbit\n* Patients requiring treatments outside standard clinical hours\n* Systemic therapy for lymphoma is not permitted within the period of time between 2 weeks prior to RT start and 2 weeks after RT completion\n* Patients who are pregnant\n* History of other malignancy within 5 years prior to screening, with the exception of those with a negligible risk of metastasis or death and\u002For treated with expected curative outcome (for example, appropriately treated non-melanoma skin cancer, carcinoma in-situ of the cervix, localized prostate cancer, breast ductal carcinoma in-situ, or stage I endometrial cancer)\n* Any medical condition that, in the investigator's judgement, would preclude the individual's safe participation in and completion of the study, or could affect interpretation of the results (e.g. pre-existing retinopathy, active connective tissue disease)\n* Inability to comply with study and follow-up procedures","ALL","18 Years",{"count":84,"type":85},36,"ESTIMATED","INTERVENTIONAL",[29],"Current standard RT doses (24-25Gy) provide excellent disease control for patients with indolent B-cell orbital lymphoma, but can cause significant late toxicities. Ultra-low dose RT (4Gy in 2 fractions) has minimal toxicity but lower disease control, requiring intensive follow-up to salvage persistent tumors. Some centers are moving towards this dose as the new standard. A recent study using 12Gy in 4 fractions to any body site showed early data suggesting high disease control rates with minimal toxicity. This study assesses 12Gy in 6 fractions, aiming to enhance disease control over 4Gy while reducing toxicity compared to 24Gy.",[90],"Orbital Lymphoma","NOT_YET_RECRUITING","2025-10-02",{"date":94,"type":95},"2025-10-07","ACTUAL",{"date":97,"type":85},"2025-11-01",{"date":99,"type":85},"2036-08-31",{"name":5,"class":6},1]