[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100636461":3},{"organization":4,"outcomesModule":7,"designInfo":29,"detailedDescription":35,"studyPopulation":28,"armGroups":36,"interventions":43,"overallOfficials":28,"centralContacts":48,"locations":54,"responsibleParty":71,"collaborators":28,"id":74,"slug":28,"hasResults":75,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":79,"eligibilityCriteria":80,"healthyVolunteers":81,"sex":82,"minAge":83,"maxAge":84,"enrollmentInfo":85,"targetDuration":28,"studyType":88,"phases":89,"briefSummary":90,"conditions":91,"keywords":28,"overallStatus":57,"whyStopped":28,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":102},{"fullName":5,"class":6},"All India Institute of Medical Sciences","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":28},[9],{"measure":10,"description":11,"timeFrame":12},"Loco-regional control rate","Loco regional control rate assessment till 2 years","2 years",[14,17,19,22,25],{"measure":15,"description":16,"timeFrame":12},"Disease free survival","Longitudinal assessment every 2 months for initial six months and every 3 months till next 2 years",{"measure":18,"description":16,"timeFrame":12},"Overall survival",{"measure":20,"description":21,"timeFrame":12},"CTCAE V5 Toxicity","CTCAE Grades\n\nGrade refers to the severity of the adverse event. The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline:\n\nGrade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting age appropriate instrumental ADL\\*.\n\nGrade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL\\*\\*.\n\nGrade 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to AE.\n\nAssessed at base line, post SBRT, post Chemotherapy, first follow up, at 6 months and then 6 monthly",{"measure":23,"description":24,"timeFrame":12},"EORTC QLQ C30 Quality of life","The QLQ-C30 is composed of both multi-item scales and single-item measures. These include five functional scales, three symptom scales, a global health status \u002F QoL scale, and six single items.\n\nEach of the multi-item scales includes a different set of items - no item occurs in more than one scale. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. High score for a functional scale represents a high \u002F healthy level of functioning, a high score for the global health status \u002F QoL represents a high QoL, but a high score for a symptom scale \u002F item represents a high level of symptomatology \u002F problems.\n\nAssessed at base line, post SBRT, post Chemotherapy, first follow up, at 6 months and then 6 monthly",{"measure":26,"description":27,"timeFrame":12},"EORTC LC-13 Quality of life","The lung cancer module incorporates one multi-item scale to assess dyspnoea, and a series of single items assessing pain, coughing, sore mouth, dysphagia, peripheral neuropathy, alopecia, and haemoptysis. It has scoring system from 1 to 4, higher score represents higher symptom burden.\n\nAssessed at base line, post SBRT, post Chemotherapy, first follow up, at 6 months and then 6 monthly",null,{"allocation":30,"interventionModel":31,"interventionModelDescription":28,"primaryPurpose":32,"observationalModel":28,"timePerspective":28,"maskingInfo":33},"NA","SINGLE_GROUP","TREATMENT",{"masking":34,"maskingDescription":28,"whoMasked":28},"NONE","The standard of care for unresectable stage III NSCLC lung cancer is combination chemoradiotherapy and best results are achieved when radiation is given along with concurrent chemotherapy \\[1\\]. Concurrent chemoradiotherapy (CRT) is associated an overall survival rate at 5 years between 15%-32% \\[1,2\\].\n\nLocal relapse in stage III NSCLC can vary from 20% to 50% \\[1-3\\]. Conventional radiation therapy results in high local failure rates that theoretically could act as a nidus for metastasis \\[1,3\\]. For NSCLC, there is a proposed dose effect on local control and survival with doses of at least 70 Gy and tumors with volumes \\>100 cc require higher doses for better local control \\[3\\]. However, in a prospective randomised controlled trial setting, CRT dose escalation with conventional radiotherapy was associated with inferior local control, PFS, OS and higher toxicity \\[2\\].\n\nStereotactic body radiotherapy (SBRT) delivers high dose conformal radiation through multiple radiation beams with steep dose gradients in 3-8 fractions and has shown limited toxicity despite delivering a high dose BED10\\>100 in early NSCLC. Local control in early-stage NSCLC with SBRT is around 85-90% \\[5, 6\\]. Ohnishi et al. in their landmark paper demonstrated significant survival benefits for stage I lung cancer with SBRT doses of biological equivalent (BED)10 in excess of 100 Gy\\[5\\]. SBRT with BED10\\>100 Gy has convincingly achieved excellent treatment out comes in early-stage NSCLC \\[7\\]. Similar local control may be achieved SBRT in stage III NSCLC provided safe dose of BED10\\>100 Gy is delivered. This holds true when tumor diameter is ≤ 6 cms.\n\nSBRT has been combined with conventional CRT in stage III NSCLC with intent to decrease local failure. A recently conducted systematic review of SBRT in inoperable stage III NSCLC has published SBRT outcomes \\[8\\].In this systematic review, 6 studies considered SBRT administration in stage III NSCLC, 1 employed SBRT in monotherapy and 5 employed SBRT as dose escalation after conventional chemoradiotherapy \\[8\\]. Median dose of conventional radiotherapy was 50.4 Gy in 28 fractions and median dose of SBRT boost was 22.25 Gy in 2 to 7 fractions. SBRT was used to treat primary tumor and involved lymph nodes in 3 out of 5 studies. The systematic review concluded that dose-escalation with 2 fraction SBRT (20-24 Gy) was feasible and was associated with local control rate of 78% at 1 year with 3.7% grade 5 and 14.2% grade 3toxicity \\[8\\].\n\nThere is data emerging on use of SBRT as monotherapy in stage III NSCLC \\[9, 10\\]. Yang et al treated ultra-central tumors with SBRT to primary and lymph nodes to a dose of 35 Gy in 5 fractions. Despite large tumors (median tumor diameter was 6.8 cm \\[range: 2.1-12.4 cms\\] and ultra-central location median local control was 17 months for stage III patients. Grade 3 or higher toxicity was observed in 9.8% of patients \\[9\\]. Another phase II trials examined the feasibility of SBRT is locally advanced NSCLC\\[10\\]. The prescribed doses were 30 Gy\u002F5daily fractions at the reference isodose (60-70%) to the tumor, and 25 Gy\u002F5 daily fractions to the clinically involved lymph nodes. Median follow-up was 87 months (range: 6-87), local PFS was 19.8 months (95% CI 9.7 - not reached), OS was 23 months. Late toxicity was represented by 24% dyspnea G3.\n\nHilar\u002Fmediastinal SBRT is a safe technique for isolated nodal disease \\[11-13\\]. A retrospective study that treated 40 patients of NSCLC with SBRT for primary\u002Foligorecurrent hilar\u002Fmediastinal lymph nodes. The median dose of SBRT was 48 Gy in 4 fractions. The aortico-pulmonary window was the target in 40%, hilum in 25%, lower paratracheal in 20%, subcarinal in 10%, and prevascular in 5%. Acute grade 3+ morbidity was seen in 3 patients (hemoptysis, pericardial\u002Fpleural effusion, heart failure) and late grade 3+ morbidity (hemoptysis) in 1 patient\\[11\\].A systematic review of SBRT on mediastinal \\& hilar lymph nodes that included 196 patients has been recently conducted \\[13\\]. Non-small cell lung cancer (NSCLC) was the most common primary (65%) tumor subjected to mediastinal \\& hilar node SBRT. The reported dose and fractionation ranged from 21 Gy to 60 Gy in 3-11 fractions, with median BED ranged from 46-106 Gy. SBRT was associated with excellent local control (LC) rates of 69%-97% \\& 1 year OS of 69%-75%. Pooled grade 3-5 toxicity rate according to Common Terminology Criteria for Adverse Events (CTCAE) v4.0 was 6% (n=11). Pooled SABR-related mortality (grade 5 toxicity) rate was 2% (n=4). Three SABR-related deaths from esophageal fistulae (2 to trachea, 1 to mediastinum) were reported, with all 3 having prior RT to the subcarinal nodes \\[13\\].\n\nGiven the safety \\& excellent efficacy of SBRT for small tumors (≤ 6cms) as well as hilar \\& medistinal lymph nodes, the present phase study is designed evaluate SBRT in stage III NSCLC.\n\nReferences\n\n1. Aupérin A, Le Péchoux C, Rolland E, et al. Meta-analysis of concomitant versus sequential radiochemotherapy in locally advanced non-small-cell lung cancer. J Clin Oncol. 2010;28:2181-2190,\n2. Bradley JD, Hu C, Komaki RR, et al. Long-term results of NRG oncology RTOG 0617: standard- versus high-dose chemoradiotherapy with or without cetuximab for unresectable Stage III non-small-cell lung cancer. J Clin Oncol. 2020; 38:706-714.\n3. McGarry RC. Integrating stereotactic body radiation therapy in stage II\u002FIII non-small cell lung cancer: is local control important? Expert Rev Anticancer Ther2014; 14:1419-27.\n4. Willner J, Baier K, Caragiani E, et al. Dose, volume and tumor control predictions in primary radiotherapy of non-small cell lung cancer. Int J Rad Oncol Biol Phys 2002;52: 382-9.\n5. Onishi H, Araki T, Shirato H, Nagata Y, et al. Stereotactic hypofractionated high-dose irradiation for stage I nonsmall cell lung carcinoma: clinical outcomes in 245 subjects in a Japanese multi-institutional study. Cancer 2004; 101: 1623-31.\n6. Timmerman R, Paulus R, Galvin J, et al. Stereotactic body radiation therapy for inoperable early stage lung cancer. JAMA 2010; 303: 1070-6.\n7. Zhang J, Yang F, Li B, et al. Which is the optimal biologically effective dose of stereotactic body radiotherapy for Stage I non-small-cell lung cancer? A meta-analysis. Int J Radiat Oncol Biol Phys 2011; 81: e305-16.\n8. Alcibar OL, Nadal E, Palomar IR, et al. Systematic review of stereotactic body radiotherapy in stage III non-small cell lung cancer. Transl Lung Cancer Res 2021;10(1):529-538.\n9. Cong Y, Sun B, Wang J, et al. Outcomes and toxicity of stereotactic body radiation therapy for advanced stage ultra-central non-small cell lung cancer. Thoracic Cancer 2019;10:1567-1575.\n10. Parisi E, GenestretiG ,Sarnelli A, et al. Accelerated hypofractionated radiotherapy plus chemotherapy for inoperable locally advanced non-small-cell lung cancer: final results of a prospective phase-II trial with a long-term follow-up. Radiation Oncology 2019 14:112.\n11. Horne ZD, Richman AH, Dohopolski MJ, Clump DA, Burton SA, Heron DE. Stereotactic body radiation therapy for isolated hilar and mediastinal non-small cell lung cancers. Lung Cancer. 2018;115:1-4.\n12. Meng MB, Wang HH, Zaorsky NG, et al., Clinical evaluation of stereotactic radiation therapy for recurrent or second primary mediastinal lymph node metastases originating from non-small cell lung cancer, Oncotarget 6 (17) (2015)15690-15703\n13. Tjong MC, Malik NH, Hanbo Chen H, et al. Stereotactic ablative radiotherapy for malignant mediastinal and hilar lymphadenopathy: a systematic review. J Thorac Dis 2020;12(5):2280-2287\n14. Brunt AD, Haviland JS, Wheatley DA, et al. Hypofractionated breast radiotherapy for 1 week versus3 weeks (FAST-Forward): 5-year efficacy and late normal tissue effects results from a multicentre, non-inferiority, randomised, phase 3 trial. The Lancet 2020;395 (10237):1613-26.",[37],{"label":38,"type":39,"description":40,"interventionNames":41},"SBRT in stage III NSCLC","EXPERIMENTAL","The study will evaluate efficacy \\& toxicity of SBRT in stage III NSCLC",[42],"Radiation: SBRT in stage III NSCLC",[44],{"type":45,"name":38,"description":46,"armGroupLabels":47,"otherNames":28},"RADIATION","SBRT to primary tumor and lymph nodes in stage III NSCLC when gross disease is \\\u003C 6 cms",[38],[49],{"name":50,"role":51,"phone":52,"phoneExt":28,"email":53},"Aman Sharma, MD","CONTACT","+91117018529339","amans757@gmail.com",[55],{"facility":56,"status":57,"city":58,"state":59,"zip":60,"country":61,"countryCode":62,"cosmosGeoPoint":63,"geoPoint":68,"contacts":69},"Nci, Aiims-Jhajjar","RECRUITING","Jhajjar","Haryana","124105","India","IN",{"type":64,"coordinates":65},"Point",[66,67],76.6565,28.6063,{"lat":67,"lon":66},[70],{"name":50,"role":51,"phone":28,"phoneExt":28,"email":53},{"type":72,"investigatorFullName":73,"investigatorTitle":73,"investigatorAffiliation":5,"oldNameTitle":28,"oldOrganization":28},"PRINCIPAL_INVESTIGATOR","Aman Sharma","100636461",false,"NCT07565987","A Phase II Trial Evaluating Upfront Stereotactic Body Radiotherapy in Stage III Advanced Non-small Cell Lung Cancer","The APRIL Trial: A Phase II Trial Evaluating Upfront Stereotactic Body Radiotherapy in Stage III Advanced Non-small Cell Lung Cancer","APRIL","Inclusion Criteria:\n\n1. Aged 18 or above and less than 75 years.\n2. Histologically proven non-small cell lung cancer.\n3. Stage T1-4, N1-3, M0 with maximum tumor size less than 6 cms and ≤ 3 stations of largest lymph node size less than 4 cms.\n4. ECOG status 0-1.\n5. Available to attend long term follow- up.\n6. Written informed consent for treatment.\n\nExclusion Criteria:\n\n1. Metastatic disease.\n2. Tumor size \\> 6cm.\n3. Involved Lymph node size greater than 4 cms \\& more than 3 station of lymph nodes involved.\n4. Patients with superior vena cava obstruction.\n5. Tumor invading\u002Fencasing the proximal bronchial tree\u002F, esophagus, pericardium.\n6. Previous radiotherapy to thorax.\n7. Small cell histology.\n8. Age\\\u003C 18 or \\> 75 years.\n9. Patients on anticoagulant therapy \\& ultra-central cavitary tumors.\n10. Poor performance status ECOG 2-3.\n11. Immunocompromised states.\n12. Viral Markers negative.\n13. Pregnant women",true,"ALL","18 Years","75 Years",{"count":86,"type":87},20,"ESTIMATED","INTERVENTIONAL",[30],"The aim of the study is to test the feasibility \\& loco-regional control rate by combining high precision SBRT with chemotherapy in stage III NSCLC in tumor\u002Flymph nodes if tumors\u002Flymph node size with ≤ 6cms in size.",[92],"Non Small Cell Lung Cancer","2026-04-30",{"date":95,"type":96},"2026-05-04","ACTUAL",{"date":98,"type":96},"2023-02-01",{"date":100,"type":87},"2027-01-30",{"name":5,"class":6},1]