[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"clinical-stage-i-esophageal-adenocarcinoma-ajcc-v8\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:clinical-stage-i-esophageal-adenocarcinoma-ajcc-v8":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,43,78],{"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},"100572370","phase-2-itraconazole-in-combination-with-ablation-for-the-prevention-of-esophageal-cancer-in-patients-with-high-risk-barretts-esophagus-100572370",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","2026-07-28",{"date":33,"type":34},"2026-07-29","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":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":52,"phases":4,"briefSummary":53,"conditions":54,"keywords":4,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":77},"100632709","a-prospective-study-of-physical-function-in-adults-who-receive-systemic-therapy-for-stage-i-iii-gastroesophageal-cancer-fast-go-study-100632709","NCT07517211","A Prospective Study of Physical Function in Adults Who Receive Systemic Therapy for Stage I-III Gastroesophageal Cancer, FAST-GO Study","A Prospective Study of Physical Function in Adults Who Receive Systemic Therapy for Stage I-III Gastroesophageal Cancer (FAST-GO)","Inclusion Criteria:\n\n* \\* Adults ≥ 18 years old at the start of study treatment.\n\n  * New diagnosis of early-stage (Stage I, II, III) esophageal, gastroesophageal junction, or gastric adenocarcinoma, squamous cell carcinoma, or poorly differentiated carcinoma.\n  * Plan to start systemic therapy for resectable or potentially resectable disease.\n  * Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n* \\* Patients with stage I disease with plans to undergo endoscopic resection or surgery alone without perioperative systemic therapy.\n\n  * Metastatic disease at the time of diagnosis.\n  * Patients who are unable to provide informed consent.\n  * Any condition that would, in the Investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures.\n  * Currently participating in another intervention research study seeking to improve functional status, alleviate frailty, increase muscle strength, or improve cognitive function.",{"count":51,"type":20},72,"OBSERVATIONAL","This study evaluates how the treatment for gastroesophageal cancer affects physical function in patients who receive chemotherapy as part of their treatment for gastroesophageal cancer.",[27,55,56,57,58,59,60,61,62,63,64,65],"Clinical Stage I Esophageal Squamous Cell Carcinoma AJCC v8","Clinical Stage I Gastric Cancer AJCC v8","Clinical Stage I Gastroesophageal Junction Adenocarcinoma AJCC v8","Clinical Stage II Esophageal Adenocarcinoma AJCC v8","Clinical Stage II Esophageal Squamous Cell Carcinoma AJCC v8","Clinical Stage II Gastric Cancer AJCC v8","Clinical Stage II Gastroesophageal Junction Adenocarcinoma AJCC v8","Clinical Stage III Esophageal Adenocarcinoma AJCC v8","Clinical Stage III Esophageal Squamous Cell Carcinoma AJCC v8","Clinical Stage III Gastric Cancer AJCC v8","Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8","NOT_YET_RECRUITING","2026-07-02",{"date":69,"type":34},"2026-07-07",{"date":71,"type":20},"2026-12-01",{"date":73,"type":20},"2029-12-01",{"name":75,"class":76},"Jonsson Comprehensive Cancer Center","OTHER",1,{"id":79,"slug":80,"hasResults":11,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":84,"eligibilityCriteria":85,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":86,"targetDuration":4,"studyType":21,"phases":88,"briefSummary":89,"conditions":90,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":5},"100522137","phase-2-preoperative-hypofractionated-radiotherapy-with-folfox-for-esophageal-or-gastroesophageal-junction-adenocarcinoma-100522137","NCT06078709","Preoperative Hypofractionated Radiotherapy With FOLFOX for Esophageal or Gastroesophageal Junction Adenocarcinoma","Preoperative Hypofractionated Radiotherapy With FOLFOX for Esophageal\u002FGastroesophageal Junction Adenocarcinoma (PHOX)","PHOX","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Histological confirmation of esophageal or gastroesophageal junction adenocarcinoma, American Joint Committee on Cancer (AJCC) 8th edition stage T1-4N0-3M0\n* Candidate for trimodality therapy: neoadjuvant chemo (immuno) therapy, chemoradiation, and esophagectomy\n* Surgical consultation has confirmed that patient is an appropriate candidate for esophagectomy\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1\n* Negative pregnancy test done ≤ 7 days prior to chemotherapy, for women of childbearing potential only\n* Ability to provide written informed consent and complete questionnaire(s) by themselves or with assistance\n* Willing to return to enrolling institution for follow-up (during the active monitoring phase of the study)\n* Willing to provide blood and tissue samples for correlative research purposes\n\nExclusion Criteria:\n\n* Clinical or biopsy-proven distant metastatic disease (AJCC 8th edition stage TanyNanyM1)\n* Cervical or upper esophageal tumor\n* Prior chemotherapy or radiotherapy for esophageal cancer or history of radiotherapy to the thorax\n* Co-morbid systemic illnesses or other severe concurrent disease which, in the judgement of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with proper assessment of adverse events\n* Receiving any investigational agent which would be considered as a treatment for the primary neoplasm or other active malignancy ≤ 1 year prior to registration that is considered by the investigator to interfere with the current treatment or measurement of outcomes\n* Any of the following:\n\n  * Pregnant women\n  * Nursing women\n  * Men or women of childbearing potential who are unwilling to employ adequate contraception",{"count":87,"type":20},99,[23],"This phase II trial tests how well preoperative (prior to surgery) radiation therapy with fluorouracil, oxaliplatin, and leucovorin calcium (FOLFOX) works for the treatment of stage I-III esophageal or gastroesophageal junction adenocarcinoma. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells and have fewer side effects. Fluorouracil stops cells from making deoxyribonucleic acid (DNA) and it may kill tumor cells. Leucovorin is not a chemotherapy medication but is given in conjunction with chemotherapy. Leucovorin is used with the chemotherapy medication fluorouracil to enhance the effects of the fluorouracil, in other words, to make the drug work better. Oxaliplatin is in a class of medications called platinum-containing antineoplastic agents. It damages the cell's DNA and may kill tumor cells. Giving preoperative hypofractionated radiation with fluorouracil and oxaliplatin may kill more tumor cells in patients with stage I-III esophageal or gastroesophageal junction adenocarcinoma.",[27,57,58,61,62,65],"2026-04-17",{"date":93,"type":34},"2026-04-20",{"date":95,"type":34},"2023-11-20",{"date":97,"type":20},"2027-05-30",{"name":99,"class":76},"Mayo Clinic"]