[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100391355":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":26,"locations":33,"responsibleParty":62,"collaborators":64,"id":71,"slug":72,"hasResults":73,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":77,"eligibilityCriteria":78,"healthyVolunteers":73,"sex":79,"minAge":80,"maxAge":20,"enrollmentInfo":81,"targetDuration":20,"studyType":84,"phases":85,"briefSummary":87,"conditions":88,"keywords":90,"overallStatus":36,"whyStopped":20,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":106},{"fullName":5,"class":6},"Cancer Trials Ireland","NETWORK",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Radiation","EXPERIMENTAL","Treatment will be delivered via image-guided (IG)-SABR in 8 fractions of 7.5Gy. OAR constraints must be respected but minimum dose coverage of 75% to 95% of the PTV will be allowed and minimum dose of 75% to 99% of the GTV will be allowed. The minimums are chosen to represent at least an equivalent BED to the RT standard fractionation of 55 Gy in 20 fractions based on actual treatment dose of 7.5Gy in 8 fractions. A total of 60 evaluable patients will be required for the study. The sample size was calculated using continuous monitoring for toxicity, up to one year post RT, using a Pocock-type boundary. Accrual will be halted if excessive numbers of ≥ Grade 3 TxR-AEs are seen. The regime will not be considered to be safe if \\>25% of evaluable patients experience a ≥ Grade 3 treatment-related adverse event (TxR-AE) by the end of 1-year post-RT. This study will be considered adequately safe if ≤ 25% of evaluable patients experience ≥ Grade 3 TxR-AE by the end of 1 year post-RT.",[13],"Radiation: Image-Guided Stereotactic Ablative Radiotherapy (IG-SABR)",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"RADIATION","Image-Guided Stereotactic Ablative Radiotherapy (IG-SABR)","Image-Guided Stereotactic Ablative Radiotherapy (IG-SABR) delivered in 8 fractions of 7.5 Gy. OAR constraints must be respected but a minimum dose coverage to 95% of the PTV will be allowed down to 75% and a minimum dose to 99% of the GTV allowed at 75%. Respiratory monitoring\u002Factive respiratory management will be used. Plans will be created and delivered using photon beams with energies between 6-10 MV.",[9],null,[22],{"name":23,"affiliation":24,"role":25},"Prof. John Armstrong, MD FRCPI DABR FFRRCSI","Cancer Trials Ireland\u002F St Luke's Radiation Oncology Network","PRINCIPAL_INVESTIGATOR",[27,31],{"name":5,"role":28,"phone":29,"phoneExt":20,"email":30},"CONTACT","+353 1 6677211","info@cancertrials.ie",{"name":32,"role":28,"phone":20,"phoneExt":20,"email":20},"Prof. John Armstrong",[34,50],{"facility":35,"status":36,"city":37,"state":20,"zip":20,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"Beacon Hospital","RECRUITING","Dublin","Ireland","IE",{"type":41,"coordinates":42},"Point",[43,44],-6.24889,53.33306,{"lat":44,"lon":43},[47,49],{"name":48,"role":28,"phone":20,"phoneExt":20,"email":20},"Prof Alina Mihai",{"name":48,"role":25,"phone":20,"phoneExt":20,"email":20},{"facility":51,"status":36,"city":37,"state":20,"zip":20,"country":38,"countryCode":39,"cosmosGeoPoint":52,"geoPoint":54,"contacts":55},"St Luke's Radiation Oncology Network (SLRON) at St Luke's Hospital and St James's Hospital",{"type":41,"coordinates":53},[43,44],{"lat":44,"lon":43},[56,57,59],{"name":32,"role":28,"phone":20,"phoneExt":20,"email":20},{"name":58,"role":25,"phone":20,"phoneExt":20,"email":20},"John Armstrong",{"name":60,"role":61,"phone":20,"phoneExt":20,"email":20},"Pierre Thirion","SUB_INVESTIGATOR",{"type":63,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR",[65,68],{"name":66,"class":67},"Technological University Dublin","UNKNOWN",{"name":69,"class":70},"University College Dublin","OTHER","100391355","phase-2-source---lung-stereotactic-ablative-radiation-therapy-of-ultracentral-lung-tumours-source-lung-100391355",false,"NCT04375904","'SOURCE - LUNG' Stereotactic Ablative Radiation Therapy Of UltRaCEntral LUNG Tumours (SOURCE Lung)","'SOURCE - LUNG' Stereotactic Ablative Radiation Therapy Of UltRaCEntral LUNG Tumours","SOURCE Lung","Inclusion Criteria:\n\n1. Written informed consent obtained prior to any study-specific procedures\n2. ≥ 18 years of age\n3. Life expectancy \\>6 months\n4. ECOG (Eastern Cooperative Oncology Group) performance status 0-2\n5. Histological diagnosis (biopsy or cytology) or radiological diagnosis (PET-positive FDG-avid tumour which has only one lesion to be treated for the purpose of the study \u002F CT-based diagnosis for non FDG-avid tumour) which requires local ablative therapy per Multi-Disciplinary Team (MDT) recommendations) of either:\n\n   (i) Primary NSCLC (Squamous Cell Carcinoma (SCC), Adenocarcinoma, Large Cell) OR (ii) Single pulmonary oligometastatic lesion to be treated for the purpose of the study\n6. Patients with central lung tumours\u002Flesions whose radiotherapy plan meets the following criteria:\n\n   (i) OAR eligibility constraints are initially exceeded when full PTV coverage is met; (ii) subsequently meets the CTRIAL-IE 18-33 SOURCE OAR Lung constraints and meets CTRIAL-IE 18-33 SOURCE Lung minimum constraints\n7. Inoperable (as per MDT) or patient refuses surgery,\n8. Females of childbearing potential must not be pregnant or lactating, must be prepared to take adequate contraception methods during treatment. Males whose female partners are of childbearing potential must be prepared to take adequate contraception methods during treatment. Examples of effective contraception methods are a condom or a diaphragm with spermicidal jelly, or oral, injectable or implanted birth control\n9. Absence of psychological, familial, sociological or geographical condition, or psychiatric illness\u002Fsocial situation potentially hampering compliance with the study protocol and follow-up schedule\n\nExclusion Criteria:\n\n1. Known co-existing or prior malignancy within the last 5 years (except for adequately treated basal cell carcinoma (BCC) or Squamous Cell Carcinoma (SCC) of the skin)) which is likely to interfere with treatment or assessment of outcomes\n2. Tumour\u002Foligometastatic lesion that is abutting the oesophagus\n3. Evidence of regional (nodal) or distant metastases or metastatic pleural effusion for patients with primary NSCLC\n4. Spinal canal involvement\n5. Patients with syndromes or conditions associated with increased radiosensitivity\n6. Idiopathic pulmonary fibrosis \u002F usual interstitial pneumonia\n7. Chemotherapy and\u002For other targeted therapy administered within 3 months prior to study radiotherapy or planned for \\\u003C6 weeks following radiotherapy for patients with primary NSCLC, or within 1 week prior to study radiotherapy or planned within 1 week following radiotherapy for patients with an oligometastatic lesion\n8. Any previous radiotherapy to the thorax or mediastinum (excluding previous breast or chest wall radiotherapy) which is likely to interfere with treatment or assessment of outcomes\n9. Any tumour not clinically definable on the treatment planning CT scan (e.g. surrounding consolidation or atelectasis)\n10. Patients unable to undergo 4D-CT scan\n11. Uncontrolled intercurrent illness that is likely to interfere with treatment or assessment of outcomes\n12. Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the study, or if it is felt by the research \u002F medical team that the patient may not be able to comply with the protocol.","ALL","18 Years",{"count":82,"type":83},68,"ESTIMATED","INTERVENTIONAL",[86],"PHASE2","This is a phase II, non-randomised study examining the safety of treating high risk centrally located non-small cell lung cancer (NSCLC) tumours and single pulmonary oligometastatic lesions using radiation therapy (RT), for patients whose disease is inoperable. The method of delivering the RT in this study is image guided stereotactic ablative radiation therapy (IG-SABR). This method involves using imaging to ensure the radiation is being delivered to the correct location within the body and using higher than normal doses per treatment (fraction) to treat the lung cancer (NSCLC)\u002Foligometastatic lung lesion. This study aims to determine its safety by looking at the number and severity of side effects. This study will deliver 8 treatments\u002Ffractions of RT with 7.5 Gy delivered in each fraction. To be eligible for this study the initial treatment plan for the patient must be shown to not fulfil certain criteria relating to doses to the tumour and surrounding normal tissue. This study has its own study specific criteria which must be adhered to. Translational sub-studies (optional) are open to patients in participating centres only. Patients will have the option to consent to participating in both translational studies or to neither.",[89],"NSCLC\u002FOligometastatic Cancer (Single Lung Lesion)",[91,92,93,94,95,96],"Lung cancer","Non-small cell lung cancer","Ultracentral","Stereotactic ablative radiation therapy","Oligometastatic cancer","Single lung lesion","2025-04-29",{"date":99,"type":100},"2025-05-02","ACTUAL",{"date":102,"type":100},"2020-12-22",{"date":104,"type":83},"2032-02",{"name":5,"class":6},2]