[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"laryngectomy-status\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:laryngectomy-status":24},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,41,66],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":26,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100522057","workshops-and-exchange-groups-for-laryngectomized-patients-100522057",false,"NCT06077643","Workshops and Exchange Groups for Laryngectomized Patients","GELAT","Inclusion Criteria:\n\n* Have had a total laryngectomy at Bichat Hospital or HEGP within the last four years\n* Have completed all the specific care of the pathology that required the total laryngectomy\n* Be able to travel to Bichat Hospital for all four sessions\n* Be over 18 years of age\n* Have received informed information about the conduct of the research.\n\nExclusion Criteria:\n\n* WHO simplified autonomy scale greater than 2, i.e. from normal activity to ambulant and able to take care of themselves, but unable to provide work and bedridden for less than 50% of their time\n* Patient who does not speak or understand French\n* Lack of affiliation to a social security scheme or CMU\n* Patient benefiting from legal protection measures (guardianship or curatorship)\n* Patient who has communicated an objection to their inclusion, after informed information.","ALL","18 Years",{"count":19,"type":20},50,"ESTIMATED","OBSERVATIONAL","This research is conducted with the aim of improving the quality of life of laryngectomized patients and their entourage. Worldwide, there are 185,000 new cases of laryngeal cancer per year. In Europe, between 2000 and 2007, the crude annual incidence rates of these cancers were 4.6\u002F100,000 with a 5-year survival rate of 61%.\n\nIn France, about 30 to 35% of cancers of the upper aerodigestive tract are localized to the larynx, or about 43,000 cases per year. Most patients are men (89%) between 50 and 70 years old. One of the treatments for these cancers is to perform an excision of the larynx thus removing the entire tumor, it is the total laryngectomy. The trachea is thus permanently removed from the skin and the digestive tract becomes independent.",[24,25],"Laryngectomy; Status","Laryngeal Cancer",[27],"Laryngectomy","RECRUITING","2026-03-26",{"date":31,"type":32},"2026-03-27","ACTUAL",{"date":34,"type":32},"2023-10-10",{"date":36,"type":20},"2026-10-10",{"name":38,"class":39},"Assistance Publique - Hôpitaux de Paris","OTHER",1,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":48,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":51,"conditions":52,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":40},"100476901","gender-disparities-in-voice-outcomes-after-tracheoesophageal-puncture-in-total-laryngectomy-patients-uc-davis-100476901","NCT05489965","Gender Disparities in Voice Outcomes After Tracheoesophageal Puncture in Total Laryngectomy Patients (UC Davis)","Gender Disparities in Voice Outcomes After Tracheoesophageal Puncture in Total Laryngectomy","Inclusion Criteria:\n\n* Male and female subjects who have completed total laryngectomy and are using TEP\n\nExclusion Criteria:\n\n* Subjects who have not completed total laryngectomy and are not using TEP",true,{"count":50,"type":20},12,"To perform a multi-site prospective study assessing, both subjectively and objectively, the gender disparities in speech outcomes of patients using TEP after total laryngectomy.\n\nThe investigators hypothesize that speech outcomes, both subjective and objective measures, will be significantly poorer for female patients compared to male patients. The outcome of the study is to prospectively assess both subjective and objective gender disparities in voice and speech outcomes of patients using TEP after total laryngectomy across a multiple institutions. The investigators hypothesize that both subjective and objective measurements of voice, speech and quality of life will be poorer for female patients in comparison to male patients.",[53,54,24,55,56],"Speech Disorders","Speech Dysfunction","Tracheoesophageal Prosthesis","Total Laryngectomy","2026-02-09",{"date":59,"type":32},"2026-02-11",{"date":61,"type":32},"2023-05-31",{"date":63,"type":20},"2026-06-01",{"name":65,"class":39},"University of California, Davis",{"id":67,"slug":68,"hasResults":11,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":72,"eligibilityCriteria":73,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":74,"enrollmentInfo":75,"targetDuration":4,"studyType":77,"phases":78,"briefSummary":80,"conditions":81,"keywords":92,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":111},"100526640","phase-2-european-larynx-organ-preservation-study-elos-mk-3475-c44-100526640","NCT06137378","European Larynx Organ Preservation Study (ELOS) [MK-3475-C44]","ELOS - Induction Chemotherapy With Docetaxel and Cisplatin Followed by Radiation Compared to Additional PD-1 Inhibition in CPS ≥1 Advanced Laryngeal\u002FHypopharyngeal Cancer Suitable for Laryngectomy Selected After Early Response Evaluation","ELOS","Inclusion Criteria:\n\nParticipants are eligible to be included in the study only if all of the following criteria apply:\n\n1. Male and female participants who are at least 18 years of age on the day of signing informed consent with histologically confirmed diagnosis of squamous cell carcinoma (SCC) of the larynx or hypopharynx according to the decision of the multidisciplinary tumor board suitable for total laryngectomy can be enrolled in this study.\n2. Stage III, IVA or IVB, whenever clear resection margins R0 \\>5 mm can be achieved and no radiologic signs of extranodal extension of neck nodes are present.\n3. Have provided newly obtained excisional biopsy of a tumor lesion not previously irradiated. Formalin-fixed, paraffin embedded (FFPE) tissue blocks are preferred to slides.\n4. PD-L1-expression\\* within the tumor biopsy, CPS ≥1\n5. Male participants:\n\n   A male participant must agree to use a contraception as detailed in Appendix 3 of this protocol during the treatment period and for at least 120 days after the last dose of study treatment and refrain from donating sperm during this period.\n6. Female participants:\n\n   A female participant is eligible to participate if she is not pregnant (see Appendix 3), not breastfeeding, and at least one of the following conditions applies:\n   1. Not a woman of childbearing potential (WOCBP) OR\n   2. A WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 120 days after the last dose of study treatment.\n7. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. Evaluation of ECOG is to be performed within 7 days prior to the date of allocation\u002Frandomization.\n8. Have adequate organ function as defined in the (Table 4) of the protocol. Specimens must be collected within 10 days prior to the start of study treatment.\n\nExclusion Criteria:\n\nParticipants are excluded from the study if any of the following criteria apply:\n\n1. A WOCBP who has a positive urine pregnancy test within 72 hours prior to receiving the first dose of study medication (see Appendix 3). If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.\n2. Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent or with an agent directed to another stimulatory or co-inhibitory receptor on T or NK cells (e.g., CTLA-4, OX 40, CD137).\n3. Has received prior systemic anti-cancer therapy including investigational agents.\n4. Has received prior radiotherapy.\n5. Has received a live vaccine or live-attenuated vaccine within 30 days prior to the first dose of study drug. Administration of killed vaccines is allowed.\n6. Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study intervention.\n7. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug.\n8. Has a history of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 2 years.\n9. Has known distant metastases including active CNS metastases and\u002For carcinomatous meningitis.\n10. Has severe hypersensitivity (≥Grade 3) to pembrolizumab and\u002For any of its excipients.\n11. Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment and is allowed.\n12. Has a history of (non-infectious) pneumonitis\u002Finterstitial lung disease that required steroids or has current pneumonitis\u002Finterstitial lung disease.\n13. Has an active infection requiring systemic therapy.\n14. Has a known history of Human Immunodeficiency Virus (HIV) infection. Note: No HIV testing is required unless mandated by local health authority.\n15. Has a known history of Hepatitis B (defined as Hepatitis B surface antigen \\[HBsAg\\] reactive) or known active Hepatitis C virus (defined as HCV RNA \\[qualitative\\] is detected) infection. Note: no testing for Hepatitis B and Hepatitis C is required unless mandated by local health authority.\n16. Has a known history of active TB (Bacillus Tuberculosis).\n17. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.\n18. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.\n19. Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of trial treatment.\n20. Has had an allogenic tissue\u002Fsolid organ transplant.\n21. Has a known intolerance to one of the substances administered during treatment including e.g. antibiotics, antiemetics, etc. or any other component of concurrent auxiliary medication.","70 Years",{"count":76,"type":20},140,"INTERVENTIONAL",[79],"PHASE2","ELOS is a prospective, randomized, open-label, controlled, two-armed parallel group, phase II multicentre trial in local advanced stage III, IVA\u002FB head and neck squamous cell carcinoma of the larynx or hypopharynx (LHNSCC) with PD-L1-expression within tumor tissue biopsy, calculated as CPS ≥ 1 curable by total laryngectomy. Induction chemotherapy (IC) with Docetaxel and Cisplatin (TP) followed by radiation will be compared to additional PD-1 inhibition. Patients will be selected after short induction early response evaluation after the first cycle IC (IC-1) aiming on larynx organ-preservation by additional 2 cycles IC followed by radiotherapy (69.6 Gy) for responders achieving endoscopic estimated tumor surface shrinkage (ETSS) ≥ 30%. Nonresponders (ETSS \\\u003C 30% or progressing disease) will receive total laryngectomy and selective neck dissection followed by postoperative radiation or chemoradiation according to the recommendation of the clinics multidisciplinary tumor board. However, Patients randomized into the intervention arm starting day 1 will receive 200 mg Pembrolizumab (MK-3475) i.v. in 3-week cycle (q3w) for 17 cycles (12 months). Treatment with pembrolizumab will continue in the experimental arm regardless of ETSS status after IC-1 in both responders and laryngectomized nonresponders, independent from subsequent decision on adjuvant therapy after TL.",[82,83,84,85,86,87,88,89,90,24,25,91],"Squamous Cell Carcinoma of Head and Neck","Hypopharyngeal Squamous Cell Carcinoma","Laryngeal Squamous Cell Carcinoma Stage III","Laryngeal Squamous Cell Carcinoma Stage IV","Squamous Cell Carcinoma of Larynx","Squamous Cell Carcinoma of the Larynx","Squamous Cell Carcinoma of the Larynx Stage III","Squamous Cell Carcinoma of the Larynx Stage IV","Laryngeal Squamous Cell Carcinoma","Laryngeal Neoplasms",[93,94,95,96,97,98,99,100,101],"induction chemotherapy","neoadjuvant treatment","immune checkpoint inhibitor","pembrolizumab","KEYNOTE","larynx organ preservation","laryngectomy-free survival","overall survival","event-free survival","2024-09-18",{"date":104,"type":32},"2024-09-20",{"date":106,"type":32},"2024-04-17",{"date":108,"type":20},"2030-12",{"name":110,"class":39},"University of Leipzig",9]