[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"clinical-stage-iia-esophageal-adenocarcinoma-ajcc-v8\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:clinical-stage-iia-esophageal-adenocarcinoma-ajcc-v8":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,43,60],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100054289","phase-2-itraconazole-in-combination-with-ablation-for-the-prevention-of-esophageal-cancer-in-patients-with-high-risk-barretts-esophagus-100054289",false,"NCT06732388","Itraconazole in Combination With Ablation for the Prevention of Esophageal Cancer in Patients With High-risk Barrett's Esophagus","Repurposing Itraconazole for Secondary Prevention of Metaplasia and Primary Prevention of Cancer in Patients With High-risk Barrett's Esophagus in Combination With Ablation","Inclusion Criteria:\n\n* Participants with history of prior esophagogastroduodenoscopy (EGD) with an established diagnosis of BE ≥ 2 cm with either low-grade dysplasia (LGD) or high-grade dysplasia (HGD) or T1a esophageal adenocarcinoma (EAC), naïve to treatment, and being considered for ablation.\n\n  * Note: An eligible diagnosis from an EGD outside of the enrollment sites is allowed for inclusion as long as the biopsies have been reviewed by two pathologists. The two pathologists could include a pathologist from the referring site and an institutional pathologist at the local enrolling site, two pathologists from the referring site, or two pathologists from the local enrolling site. The diagnosis between two pathologists has to be concordant regarding the presence of dysplasia or cancer. Discrepant diagnoses will be resolved by a third pathologist, if needed\n* Participants older than 18 years will be enrolled. Because the incidence of BE and related cancer is very low in participants \\\u003C 18 years of age, children are excluded from this study\n* Clinically eligible for EGD and endoscopic treatment of BE\n* Absolute neutrophil count ≥ 1,000\u002Fmicroliter\n* Platelets ≥ 100,000\u002Fmicroliter\n* Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN)\n\n  * Note: Higher total bilirubin levels (≤ 3 mg\u002FdL) can be allowed if due to known benign liver condition, i.e. Gilbert's\n* Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \\[SGOT\\])\u002Falanine aminotransferase (ALT) (serum glutamic-pyruvic transaminase \\[SGPT\\]) ≤ 1.5 × institutional upper limit of normal\n* Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial\n* For participants with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated\n* Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load\n* Participants on chronic suppressive antiviral therapy for herpes simplex virus (HSV) are eligible\n* There are no controlled data on the effects of itraconazole on the developing human fetus at the recommended therapeutic dose. For this reason and because azoles are known to be teratogenic, women of child-bearing potential must agree to use one or more methods of highly effective contraception that do not contain estrogen (e.g. progestin only oral contraceptive, non-hormonal intrauterine device, bilateral tubal ligation) two months prior to study entry, for the duration of study participation and two months after completing the study drug. Women should not donate eggs or participate in in vitro fertilization for the duration of study participation, and two months after completing the study drug. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her study physician immediately. Male subjects should avoid donating sperm, and if engaged in intercourse with women of child-bearing potential use a method of highly effective contraception.\n\n  * Activities of Reproductive Potential: In addition to heterosexual intercourse, activities that could lead to pregnancy (e.g. sperm or egg donation, participation in in vitro fertilization) should be considered when evaluating the reproductive potential of clinical trial subjects.\n  * Females of Reproductive Potential: A non-post-menopausal female who has not had a bilateral oophorectomy or medically documented ovarian failure. A female who has had a tubal ligation sterilization, or hysterectomy would not be considered to be of reproductive potential unless participating in activities of reproductive potential other than heterosexual intercourse (e.g. egg donation, participation in in vitro fertilization).\n  * Menopause:\n\n    * Twelve (12) months of spontaneous amenorrhea or;\n    * Spontaneous amenorrhea with serum follicle stimulating hormone (FSH) levels \\> 40 mIU\u002FmL or;\n    * Subject is post-bilateral oophorectomy with or without hysterectomy\n* Ability to understand and the willingness to sign a written informed consent document\n\nExclusion Criteria:\n\n* Current New York Heart Association (NYHA) class III or IV congestive heart failure\n* Prolonged corrected QT (QTc) (\\> 450 ms for men and \\> 470 ms for women)\n* Participants may not be receiving any other investigational agents\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to itraconazole\n* Uncontrolled intercurrent illness., or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n* Pregnant women are excluded from this study because itraconazole is a class C agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events (AEs) in nursing infants secondary to treatment of the mother with itraconazole, breastfeeding should be discontinued if the mother is treated with itraconazole\n* Critical drug interactions (grades D or higher) with other medications metabolized by cytochrome P450(CYP)3A4 (if the medication cannot be discontinued or switched or dose modified); these decisions will be made on a case-by-case basis by the site investigators in consultation with the treating provider. Drug interactions can be assessed using one of the available on-line resources, for instance, UpToDate or Clinical Formulary and\u002For in collaboration with a clinical pharmacist.\n\n  * Note: If there are potential drug interactions that do not exclude the participant from the study, a brief research note summarizing the decision-making process about potential drug interactions and their management will be required before the participants are enrolled in the trial\n* History of eosinophilic esophagitis\n* History of strictures not allowing passage of the radiofrequency ablation (RFA) assembly\n* Participants must not have evidence of active\u002Frecurrent invasive cancer of a non-esophageal organ\n* Participants with EAC greater than stage T1a\n* Persistent (\\> 24 hour \\[h\\]) systolic blood pressure (BP) greater than or equal to 160 mmHg (to avoid reaching hypertensive crisis defined as systolic BP \\> 180 mmHg)\n* Patients taking eliglustat. Co-administration of itraconazole and eliglustat is contraindicated in subjects that are poor or intermediate metabolizers of CYP2D6","ALL","18 Years",{"count":19,"type":20},76,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","This phase II trial tests how well itraconazole works in combination with the usual standard of care endoscopy with ablation for the prevention of esophageal cancer in patients who have high-risk Barrett's esophagus (BE). BE is a condition in which the lining of the esophagus changes and becomes more like the tissue that lines the intestine. People with Barrett's esophagus have a higher risk of developing esophageal cancer. Itraconazole is a drug used to prevent or treat fungal infections. Ablation refers to the removal of abnormal tissue using heat. Endoscopy is a procedure for looking at the esophagus using a long, flexible tube called an endoscope, which has a video camera at the end. Radiofrequency ablation is a type of heat therapy that uses radiofrequency energy (similar to microwave heat) to destroy the abnormal tissue in the esophagus. Giving itraconazole in combination with standard of care endoscopy with ablation may improve the effects of ablation and prevent esophageal cancer in patients with high-risk Barrett's esophagus.",[26,27,28,29],"Barrett Esophagus","Clinical Stage I Esophageal Adenocarcinoma AJCC v8","Clinical Stage IIA Esophageal Adenocarcinoma AJCC v8","Esophageal Adenocarcinoma","RECRUITING","2026-07-10",{"date":33,"type":34},"2026-07-13","ACTUAL",{"date":36,"type":34},"2026-06-23",{"date":38,"type":20},"2030-12-01",{"name":40,"class":41},"National Cancer Institute (NCI)","NIH",6,{"id":44,"slug":4,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":47,"targetDuration":4,"studyType":21,"phases":49,"briefSummary":24,"conditions":50,"keywords":4,"overallStatus":51,"whyStopped":4,"lastUpdateSubmitDate":52,"lastUpdatePostDateStruct":53,"startDateStruct":55,"completionDateStruct":57,"leadSponsor":59,"locationsCount":42},"100572370","Repurposing Itraconazole for Secondary Prevention of Metaplasia and Primary Prevention of Cancer in Patients With High-Risk Barrett's Esophagus in Combination With Ablation","Inclusion Criteria:\n\n* Participants with history of prior esophagogastroduodenoscopy (EGD) with an established diagnosis of BE ≥ 2 cm with either low-grade dysplasia (LGD) or high-grade dysplasia (HGD) or T1a esophageal adenocarcinoma (EAC), naïve to treatment, and being considered for ablation.\n\n  * Note: An eligible diagnosis from an EGD outside of the enrollment sites is allowed for inclusion as long as the biopsies have been reviewed by two pathologists. The two pathologists could include a pathologist from the referring site and an institutional pathologist at the local enrolling site, two pathologists from the referring site, or two pathologists from the local enrolling site. The diagnosis between two pathologists has to be concordant regarding the presence of dysplasia or cancer. Discrepant diagnoses will be resolved by a third pathologist, if needed\n* Participants older than 18 years will be enrolled. Because the incidence of BE and related cancer is very low in participants \\\u003C 18 years of age, children are excluded from this study\n* Clinically eligible for EGD and endoscopic treatment of BE\n* Absolute neutrophil count ≥ 1,000\u002Fmicroliter\n* Platelets ≥ 100,000\u002Fmicroliter\n* Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN)\n\n  * Note: Higher total bilirubin levels (≤ 3 mg\u002FdL) can be allowed if due to known benign liver condition, i.e. Gilbert's\n* Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \\[SGOT\\])\u002Falanine aminotransferase (ALT) (serum glutamic-pyruvic transaminase \\[SGPT\\]) ≤ 1.5 × institutional upper limit of normal\n* Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial\n* For participants with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated\n* Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load\n* Participants on chronic suppressive antiviral therapy for herpes simplex virus (HSV) are eligible\n* There are no controlled data on the effects of itraconazole on the developing human fetus at the recommended therapeutic dose. For this reason and because azoles are known to be teratogenic, women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) two months prior to study entry, for the duration of study participation and two months after completing the study drug. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her study physician immediately\n* Ability to understand and the willingness to sign a written informed consent document\n\nExclusion Criteria:\n\n* Current New York Heart Association (NYHA) class III or IV congestive heart failure\n* Prolonged corrected QT (QTc) (\\> 450 ms for men and \\> 470 ms for women)\n* Participants may not be receiving any other investigational agents\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to itraconazole\n* Uncontrolled intercurrent illness., or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n* Pregnant women are excluded from this study because itraconazole is a class C agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events (AEs) in nursing infants secondary to treatment of the mother with itraconazole, breastfeeding should be discontinued if the mother is treated with itraconazole\n* Critical drug interactions (grades D or higher) with other medications metabolized by cytochrome P450(CYP)3A4 (if the medication cannot be discontinued or switched or dose modified); these decisions will be made on a case-by-case basis by the site investigators in consultation with the treating provider. Drug interactions can be assessed using one of the available on-line resources, for instance, UpToDate or Clinical Formulary and\u002For in collaboration with a clinical pharmacist.\n\n  * Note: If there are potential drug interactions that do not exclude the participant from the study, a brief research note summarizing the decision-making process about potential drug interactions and their management will be required before the participants are enrolled in the trial\n* History of eosinophilic esophagitis\n* History of strictures not allowing passage of the radiofrequency ablation (RFA) assembly\n* Participants must not have evidence of active\u002Frecurrent invasive cancer of a non-esophageal organ\n* Participants with EAC greater than stage T1a",{"count":48,"type":20},64,[23],[26,27,28,29],"NOT_YET_RECRUITING","2026-05-12",{"date":54,"type":34},"2026-05-13",{"date":56,"type":20},"2026-10-06",{"date":58,"type":20},"2030-02-01",{"name":40,"class":41},{"id":61,"slug":62,"hasResults":11,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":4,"eligibilityCriteria":66,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":67,"targetDuration":4,"studyType":21,"phases":69,"briefSummary":71,"conditions":72,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":95},"100409709","phase-1-nbtxr3-chemotherapy-and-radiation-therapy-for-the-treatment-of-esophageal-cancer-100409709","NCT04615013","NBTXR3, Chemotherapy, and Radiation Therapy for the Treatment of Esophageal Cancer","A Phase 1 Study of NBTXR3 Activated by Radiotherapy With Concurrent Chemotherapy for Adenocarcinoma of the Esophagus","Inclusion Criteria:\n\n* Biopsy proven adenocarcinoma of the cervical or thoracic esophagus or gastroesophageal junction\n* Adenocarcinoma of the esophagus stages II-III allowed\n* Medically able to receive chemoradiation. Following chemotherapy regimens are allowed:\n\n  * Oxaliplatin and fluorouracil (5-FU) or capecitabine\n  * Docetaxel and\u002For 5-FU or paclitaxel\n  * Carboplatin and paclitaxel\n* Amenable to undergo the endoscopic ultrasound (EUS) guided injection of NBTXR3 as determined by the investigator or treating physician\n\n  * Patients with lesions for which the EUS scope is not able to traverse the tumor are allowed on this trial as long as an injection can be performed as per treating physician's discretion\n* Has at least 1 and up to 4 target lesion(s) in the esophagus that are measurable on cross sectional imaging and repeated measurements (via Response Evaluation Criteria in Solid Tumors \\[RECIST\\] version \\[v\\] 1.1) at the same anatomical location should be achievable\n\n  * Local nodal disease around the esophagus allowed\n  * Nodal target lesions must be \\>= 15 mm (short axis) based on computed tomography (CT) (slice thickness of 5 mm or less) or magnetic resonance imaging (MRI)\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-2\n* Hemoglobin \\>= 8.0 g\u002FdL\n* Absolute neutrophil count (ANC) \\>= 1,500\u002Fmm\\^3\n* Platelet count \\>= 100,000\u002Fmm\\^3\n* Creatinine =\\\u003C 1.5 x upper limit of normal (ULN)\n* Calculated (Calc.) creatinine clearance \\> 30 mL\u002Fmin\n* Glomerular filtration ratio \\> 40 mL\u002Fmin per 1.73 m\\^2\n* Total bilirubin =\\\u003C 2.0 mg\u002FdL\n* Aspartate aminotransferase (AST)\u002Falanine aminotransferase (ALT) =\\\u003C 2.5 x upper limit of normal (ULN)\n* Negative urine or serum pregnancy test =\\\u003C 7 days of NBTXR3 injection in all female participants of child-bearing potential\n* Signed informed consent form (ICF) indicating that participant understands the purpose of, and procedures required for, the study and is willing to participate in the study\n\nExclusion Criteria:\n\n* Prior radiation or any therapy for the treatment of esophageal cancer\n* Prior surgical resection of esophageal tumor\n* Esophageal cancer with radiographic evidence of metastases at screening\n* At screening, past medical history of:\n\n  * Esophageal fistula\n  * Tracheoesophageal fistula\n  * Siewert type III tumors\n* Evidence of bulky disease and\u002For abutment of tumor above the carina that may result in tracheoesophageal fistulas as determined by the investigator or treating physician\n\n  * Tumors above the carina without defacement of the fat plane between tumor and the airway are allowed\n* Known uncontrolled (grade \\>= 2) or active esophageal or gastric ulcer disease within 28 days of enrollment\n* Known contraindication to iodine-based or gadolinium-based intravenous (IV) contrast\n* Active malignancy, in addition to esophageal cancer except for basal cell carcinoma of the skin or non-metastatic low risk prostate cancer definitively treated and relapse free within at least 3 months from time of screening\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, renal failure, cardiac arrhythmia, or psychiatric illness that would limit compliance with treatment\n* Known active, uncontrolled (high viral load) human immunodeficiency virus (HIV) or hepatitis B or hepatitis C infection\n* Female patients who are pregnant or breastfeeding\n* Women of child-bearing potential and their male partners who are unwilling or unable to use an acceptable method of birth control to avoid pregnancy for the entire study period. Acceptable methods of contraception are those that, alone or in combination, result in a failure rate of \\\u003C 1% per year when used consistently and correctly\n* Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (e.g., compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments",{"count":68,"type":20},24,[70],"PHASE1","The purpose of this Phase I study is to determine the recommended phase 2 dose (RP2D) and safety profile of NBTXR3 activated by radiation therapy with concurrent chemotherapy for the treatment of patients with esophageal adenocarcinoma. NBTXR3 is a drug that when activated by radiation therapy, may cause targeted destruction of cancer cells. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Chemotherapy drugs, such as oxaliplatin, fluorouracil, capecitabine, docetaxel, paclitaxel, and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving NBTXR3 activated by radiation therapy with concurrent chemotherapy may help control the disease.",[73,74,28,75,76,77,78,79,80,81,82,83,84],"Cervical Esophagus Adenocarcinoma","Clinical Stage II Esophageal Adenocarcinoma AJCC v8","Clinical Stage IIB Esophageal Adenocarcinoma AJCC v8","Clinical Stage III Esophageal Adenocarcinoma AJCC v8","Gastroesophageal Junction Adenocarcinoma","Pathologic Stage II Esophageal Adenocarcinoma AJCC v8","Pathologic Stage IIA Esophageal Adenocarcinoma AJCC v8","Pathologic Stage IIB Esophageal Adenocarcinoma AJCC v8","Pathologic Stage III Esophageal Adenocarcinoma AJCC v8","Pathologic Stage IIIA Esophageal Adenocarcinoma AJCC v8","Pathologic Stage IIIB Esophageal Adenocarcinoma AJCC v8","Thoracic Esophagus Adenocarcinoma","2026-04-13",{"date":87,"type":34},"2026-04-16",{"date":89,"type":34},"2020-11-23",{"date":91,"type":20},"2027-10-31",{"name":93,"class":94},"M.D. Anderson Cancer Center","OTHER",1]