[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05354570":3,"trial-entities:NCT05354570":156,"trial-summary:NCT05354570":161},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":15,"conditions":17,"keywords":20,"study_type":22,"primary_purpose":23,"phases":24,"enrollment_info":26,"interventions":29,"primary_outcomes":35,"secondary_outcomes":40,"sex":45,"minimum_age":46,"maximum_age":47,"healthy_volunteers":48,"eligibility_criteria":49,"std_ages":72,"locations":75,"central_contacts":143,"overall_officials":149,"references":152,"see_also_links":153},"NCT05354570","22-098","A Study of Intensity-Modulated Pleural Radiation Therapy (IMPRINT) in People With Thymic Cancer That Has Spread to the Lining of the Lungs and Chest","Phase II Study of Hemithoracic Intensity-Modulated Pleural Radiation Therapy (IMPRINT) for Patients With Pleural Metastases From Thymic Malignancies","RECRUITING","2027-04","2026-05","2026-05-06","2022-04-26","Memorial Sloan Kettering Cancer Center","OTHER",null,"The researchers are doing this study to find out whether hemithoracic intensity-modulated pleural radiation therapy (IMPRINT) is a safe treatment that causes few or mild side effects in people with pleural metastases from thymic malignancies. The researchers will also look at whether hemithoracic IMPRINT is effective against participants' cancer.",[18,19],"Thymic Malignancies","Pleural Metastases",[21,5],"Intensity-Modulated Pleural Radiation Therapy (IMPRINT)","INTERVENTIONAL","TREATMENT",[25],"PHASE2",{"count":27,"type":28},36,"ESTIMATED",[30],{"type":31,"name":21,"description":32,"armGroupLabels":33},"RADIATION","Radiation therapy will be administered over approximately 6 weeks at 50.4 Gy in 28 fractions, including an optional dose-painting SIB to gross residual disease up to 60 Gy while respecting normal tissue constraints.",[34],"Hemithoracic Intensity-Modulated Pleural Radiation Therapy (IMPRINT)",[36],{"measure":37,"description":38,"timeFrame":39},"assess the rate of radiation pneumonitis","as indicated by the rate of grade 3 or higher radiation pneumonitis defined by the NCI Common Terminology Criteria (CTC) version 5.0.","2 years",[41],{"measure":42,"description":43,"timeFrame":44},"progression-free survival (PFS)","PFS events will include death and\u002For progression of thymic malignancy due to local-regional or distant recurrence\u002Fprogression. PFS will be calculated from the start of radiation treatment and will be estimated by the Kaplan-Meier method.","12 month","ALL","18 Years","79 Years",false,{"inclusion":50,"exclusion":59,"raw_text":71},[51,52,53,54,55,56,57,58],"Provide written informed consent to participate on the study","Patients must have a pathologically confirmed diagnosis of thymic malignancy. Thymic carcinoma is allowed.","Patients must have radiologic or pathologic evidence of pleural metastases. Patients may have de novo stage IVA or recurrent disease in the pleura. Gross disease in the fissure is allowed if resected.","No evidence of extrathoracic metastatic disease or contralateral pleural\u002Fpericardial disease.","Patient age ≥ 18 years but ≤ 80 years at the time of consent","Karnofsky performance status ≥ 80%","Preoperative or Postoperative Pulmonary Function Tests: DLCO \\> 40% predicted (corrected for Hgb) and FEV1 ≥ 35% (corrected for Hgb)","Glomerular filtration rate (GFR): ≥50 mL\u002Fmin\u002F1.73 m2 (must be calculated using estimated creatinine clearance (CrCl) by the Cockcroft-Gault (C-G) equation (Nephron 1976;16:31-41): CrCl (mL\u002Fmin) = \\[140 - age (years)\\] x weight (kg) \\[x 0.85 for female patients\\] 72 x serum creatinine (mg \u002F dL) ° In cases of concern about decreased renal function and potential high radiation dose to the kidneys, an optional nuclear medicine kidney function scan may be performed prior to radiation therapy to determine the functional contribution of each kidney.",[60,61,62,63,64,65,66,67,68,69,70],"Continuous oxygen use","Patients with an acute flare of myasthenia gravis requiring addition of new medication in the past 6 months","Prior nephrectomy on the contralateral side of the pleural metastases","Prior thoracic radiation therapy preventing hemithoracic pleural IMRT. Prior thymic bed radiation is allowed. Prior pleural SBRT is allowed.","Patients undergoing extrapleural pneumonectomy. Other surgical resection approaches of the pleural nodules (ex: P\u002FD, debulking\u002Fmetastasectomy) are allowed. Surgical resection of the primary thymic tumor is allowed.","Acute congestive heart failure requiring hospitalization within the past 30 days.","COPD requiring chronic oral steroid therapy of \\> 10 mg prednisone daily or equivalent at the time of registration. Inhaled corticosteroids are allowed","Unstable angina requiring hospitalization and\u002For transmural myocardial infarction within the last 3 months","History of interstitial lung disease","Pregnant or lactating women","Men or women not using effective contraception","Inclusion Criteria:\n\n* Provide written informed consent to participate on the study\n* Patients must have a pathologically confirmed diagnosis of thymic malignancy. Thymic carcinoma is allowed.\n* Patients must have radiologic or pathologic evidence of pleural metastases. Patients may have de novo stage IVA or recurrent disease in the pleura. Gross disease in the fissure is allowed if resected.\n* No evidence of extrathoracic metastatic disease or contralateral pleural\u002Fpericardial disease.\n* Patient age ≥ 18 years but ≤ 80 years at the time of consent\n* Karnofsky performance status ≥ 80%\n* Preoperative or Postoperative Pulmonary Function Tests: DLCO \\> 40% predicted (corrected for Hgb) and FEV1 ≥ 35% (corrected for Hgb)\n* Glomerular filtration rate (GFR): ≥50 mL\u002Fmin\u002F1.73 m2 (must be calculated using estimated creatinine clearance (CrCl) by the Cockcroft-Gault (C-G) equation (Nephron 1976;16:31-41): CrCl (mL\u002Fmin) = \\[140 - age (years)\\] x weight (kg) \\[x 0.85 for female patients\\] 72 x serum creatinine (mg \u002F dL) ° In cases of concern about decreased renal function and potential high radiation dose to the kidneys, an optional nuclear medicine kidney function scan may be performed prior to radiation therapy to determine the functional contribution of each kidney.\n\nExclusion Criteria:\n\n* Continuous oxygen use\n* Patients with an acute flare of myasthenia gravis requiring addition of new medication in the past 6 months\n* Prior nephrectomy on the contralateral side of the pleural metastases\n* Prior thoracic radiation therapy preventing hemithoracic pleural IMRT. Prior thymic bed radiation is allowed. Prior pleural SBRT is allowed.\n* Patients undergoing extrapleural pneumonectomy. Other surgical resection approaches of the pleural nodules (ex: P\u002FD, debulking\u002Fmetastasectomy) are allowed. Surgical resection of the primary thymic tumor is allowed.\n* Acute congestive heart failure requiring hospitalization within the past 30 days.\n* COPD requiring chronic oral steroid therapy of \\> 10 mg prednisone daily or equivalent at the time of registration. Inhaled corticosteroids are allowed\n* Unstable angina requiring hospitalization and\u002For transmural myocardial infarction within the last 3 months\n* History of interstitial lung disease\n* Pregnant or lactating women\n* Men or women not using effective contraception",[73,74],"ADULT","OLDER_ADULT",[76,90,99,108,118,127,134],{"facility":77,"status":8,"city":78,"state":79,"zip":80,"country":81,"contacts":82,"geoPoint":87},"Memorial Sloan Kettering Basking Ridge (Limited protocol activities)","Basking Ridge","New Jersey","07920","United States",[83],{"name":84,"role":85,"phone":86},"Charles Simone, MD","CONTACT","212-639-3716",{"lat":88,"lon":89},40.70621,-74.54932,{"facility":91,"status":8,"city":92,"state":79,"zip":93,"country":81,"contacts":94,"geoPoint":96},"Memorial Sloan Kettering Monmouth (Limited protocol activities)","Middletown","07748",[95],{"name":84,"role":85,"phone":86},{"lat":97,"lon":98},40.39428,-74.11709,{"facility":100,"status":8,"city":101,"state":79,"zip":102,"country":81,"contacts":103,"geoPoint":105},"Memorial Sloan Kettering Bergen (Limited protocol activities)","Montvale","07645",[104],{"name":84,"role":85,"phone":86},{"lat":106,"lon":107},41.04676,-74.02292,{"facility":109,"status":8,"city":110,"state":111,"zip":112,"country":81,"contacts":113,"geoPoint":115},"Memorial Sloan Kettering Suffolk - Commack (Limited protocol activities)","Commack","New York","11725",[114],{"name":84,"role":85,"phone":86},{"lat":116,"lon":117},40.84288,-73.29289,{"facility":119,"status":8,"city":120,"state":111,"zip":121,"country":81,"contacts":122,"geoPoint":124},"Memorial Sloan Kettering Westchester (Limited protocol activities)","Harrison","10604",[123],{"name":84,"role":85,"phone":86},{"lat":125,"lon":126},40.96899,-73.71263,{"facility":13,"status":8,"city":111,"state":111,"zip":128,"country":81,"contacts":129,"geoPoint":131},"10065",[130],{"name":84,"role":85,"phone":86},{"lat":132,"lon":133},40.71427,-74.00597,{"facility":135,"status":8,"city":136,"state":111,"zip":137,"country":81,"contacts":138,"geoPoint":140},"Memorial Sloan Kettering Nassau (Limited protocol activities)","Rockville Centre","11553",[139],{"name":84,"role":85,"phone":86},{"lat":141,"lon":142},40.65871,-73.64124,[144,146],{"name":84,"role":85,"phone":86,"email":145},"simonec1@mskcc.org",{"name":147,"role":85,"email":148},"Andrew Pagano, MD","paganoa@mskcc.org",[150],{"name":84,"affiliation":13,"role":151},"PRINCIPAL_INVESTIGATOR",[],[154],{"label":13,"url":155},"http:\u002F\u002Fwww.mskcc.org\u002Fmskcc\u002Fhtml\u002F44.cfm",{"nct_id":4,"conditions":157,"biomarkers":160},[158,159],"Malignant Thymus Neoplasm","Metastatic Malignant Neoplasm in the Pleura",[],{"nct_id":4,"found":162,"summary":163,"prompt_version":173},true,{"design":164,"status":165,"heading":166,"summary":167,"follow_up":168,"word_count":169,"commitments":170,"compensation":171,"drugs_mentioned":172},"This study is an interventional study planning to enroll 36 participants. It is not specified if it is randomized or blinded.","completed","IMPRINT for Thymic Cancer with Pleural Metastases","This study is looking at a treatment called Intensity-Modulated Pleural Radiation Therapy (IMPRINT) for people with thymic cancer that has spread to the lining of the lungs and chest (pleural metastases). Researchers want to see if IMPRINT is safe and causes few or mild side effects. They will also check how well it works against the cancer. You might be able to join if you are between 18 and 79 years old, have a confirmed diagnosis of thymic cancer, and have evidence of cancer spread to the pleura. The main goal is to measure the rate of a lung side effect called radiation pneumonitis after two years. The current status of this study is unclear.","Researchers will assess a specific side effect (radiation pneumonitis) for up to 2 years after treatment.",115,"You would receive radiation therapy over approximately 6 weeks. This involves 28 treatment sessions.","Not stated in the trial record.",[21],"v2"]