[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Olgun Elicin\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":92},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,58],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":33,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":46,"lastUpdatePostDateStruct":47,"startDateStruct":50,"completionDateStruct":52,"leadSponsor":54,"locationsCount":57},"100597462","phase-2-compartmentalized-postoperative-radiotherapy-in-head-and-neck-cancer-100597462",false,"NCT07058805","Compartmentalized Postoperative Radiotherapy in Head and Neck Cancer","COMPORT: Compartmentalization in Postoperative Radiotherapy for Head and Neck Squamous Cell Carcinoma - A Phase II Clinical Trial","COMPORT","Inclusion criteria\n\n1. ECOG performance status 0-2 at the time of registration\n2. ≥18 years of age\n3. Baseline assessments and documentation of toxicity using CTCAE v.5 and QoL using EORTC C30 and HN43 questionnaires.\n4. Histopathologically confirmed, surgically treated squamous cell carcinoma of the oral cavity, oropharynx, larynx or hypopharynx\n5. No previous neoadjuvant systemic therapy or previous neoadjuvant systemic therapy (chemotherapy, immunotherapy or combinations) is permitted only if its neoadjuvant use for locally advanced HNSCC is approved by Swissmedic and routinely reimbursed at the time it was administered or if it was administered as part of routine institutional treatment decisions, outside of a clinical trial or other investigational framework.\n6. Standard indication for PORT via external beam radiotherapy (with or without concomitant systemic treatment) defined by a multidisciplinary head and neck tumor board (MDT).\n7. History and physical examination by treating radiation oncologist within 28 days prior to registration.\n8. MRI of the head and neck (or computerized tomography as substitute) with i.v. contrast, if not contraindicated. CT of the chest with i.v. contrast, if not contraindicated. 18FDG-PET\u002FCT can be used instead of CT of the chest. The baseline imaging examinations include the preoperative diagnostic phase and do not have to be repeated if performed within 60 days prior to the enrollment.\n9. The multidisciplinary team (MDT) must determine that the patient can safely undergo the standard treatment, which may include PORT with or without additional systemic treatment.\n10. Post-menopausal women, or women of child-bearing potential who use or agree to use effective contraception, are not pregnant and agree not to become pregnant during and within 30 days after PORT. A negative pregnancy test before inclusion (within 28 days) into the trial is required for all women with child-bearing potential. Men agree not to father a child during and within three months after PORT.\n11. Written informed consent, signed by the patient and the investigator.\n\nExclusion criteria\n\n1. Synchronous or previous malignancies. Exceptions are curatively treated basal cell carcinoma or SCC of the skin, or in situ carcinoma of the cervix uteri, low- or intermediate- risk prostate cancer, or breast with a progression-free follow-up time of at least 3 years without any remaining disease burden, or other previous malignancy with a progression-free interval of at least 5 years without any remaining active\u002Fprogressive disease burden regardless whether the treatment is completed or ongoing as a maintenance treatment (e.g. androgen deprivation therapy for prostate cancer).\n2. Presence of distant metastases c\u002FpM1.\n3. Neoadjuvant systemic therapy administered under a clinical trial protocol or as part of any structured investigational framework not considered standard institutional practice at the time of administration.\n4. Previous radiation dose applied to the anatomical sites overlapping with the standard PORT target volumes which may have a potential impact on the delivered dose and\u002For toxicity profile of the standard PORT.\n5. R2 resection of the primary tumor or any involved lymph node.\n6. Last oncologic surgery for the index HNSCC performed more than 6 weeks ago.\n7. Inadequate reporting of the pathology not conformal with COMPORT algorithm and no possibility of an adequate post-hoc acquisition of the necessary information (see the section 8)\n8. Co-existing disease prejudicing survival (expected survival less than 6 months).\n9. Active bacterial or fungal infection requiring intravenous antibiotics at the time of registration.\n10. Illness expected to preclude PORT within 7 days of registration.\n11. Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial.\n12. Ongoing participation in another interventional clinical trial which are not exempted by the sponsor. Exceptions may apply depending on the trial methodology (Please contact sponsor for clarification).","ALL","18 Years",{"count":20,"type":21},50,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","COMPORT is a multicenter phase II clinical trial evaluating a personalized approach to postoperative radiotherapy in patients with head and neck squamous cell carcinoma (HNSCC). The study investigates whether a risk-adapted, compartmentalized radiotherapy strategy can safely reduce the treatment volume, and thus the side effects, without increasing the risk of tumor recurrence. Eligible patients are those with surgically treated cancers of the oral cavity, oropharynx, larynx, or hypopharynx who have a standard indication for postoperative radiotherapy. The primary outcome is the rate of recurrence in anatomical compartments that would normally be irradiated but are intentionally omitted in this study. COMPORT aims to generate high-level evidence to support a more personalized and less toxic standard of care in postoperative head and neck cancer management.",[27,28,29,30,31,32],"Head and Neck Cancer","Head and Neck Squamous Cell Carcinoma","Oral Cavity Squamous Cell Carcinoma","Oropharyngeal Squamous Cell Carcinoma","Laryngeal Squamous Cell Carcinoma","Hypopharyngeal Squamous Cell Carcinoma",[27,34,35,36,37,38,39,40,41,42,43,44],"radiotherapy","Postoperative Radiotherapy","De-escalation","Compartmentalization","Phase II","Quality of life","Bayesian Analysis","TAME","EORTC QLQ-C30","EORTC QLQ-HN43","adjuvant treatment","RECRUITING","2026-04-29",{"date":48,"type":49},"2026-05-06","ACTUAL",{"date":51,"type":49},"2026-01-15",{"date":53,"type":21},"2029-04",{"name":55,"class":56},"Olgun Elicin","OTHER",3,{"id":59,"slug":60,"hasResults":11,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":64,"eligibilityCriteria":65,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":66,"targetDuration":4,"studyType":22,"phases":68,"briefSummary":70,"conditions":71,"keywords":74,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},"100366895","voices-voice-quality-after-transoral-co2-laser-surgery-versus-single-vocal-cord-irradiation-for-larynx-cancer-100366895","NCT04057209","VoiceS: Voice Quality After Transoral CO2-Laser Surgery Versus Single Vocal Cord Irradiation for Larynx Cancer","VoiceS: Voice Quality After Transoral CO2-Laser Surgery Versus Single Vocal Cord Irradiation for Unilateral Stage 0 & I Glottic Larynx Cancer - A Randomized Phase III Trial","VoiceS","Inclusion Criteria\n\n1. ECOG performance status 0-1 at the time of registration\n2. ≥18 years of age\n3. Baseline assessments and documentation of voice quality by means of VHI, JS, RBH, GNE, SPR\n4. Histopathologically confirmed, previously untreated unilateral (cT1a or unilateral cTis) stage 0 or I glottic larynx cancer based on the UICC staging system (8th edition)\n5. History and physical examination by treating physician (head and neck surgeon and radiation oncologist) within 28 days prior registration\n6. The patient must be expected to withstand both study interventions\n7. The patient must have undergone panendoscopy with assessment for the feasibility of transoral exposure for resection. Patients without feasible exposure are not eligible\n8. Localization of the tumor should allow resection with a minimum of 2 mm macroscopical margin without extension to the contralateral vocal fold, without partial resection of the arytenoid cartilage and without resection of parts of thyroid cartilage (Cordectomy Type I-IV according the classification of the European Laryngological Society)13\n9. Hemoglobin ≥10 g\u002FdL or 6.2 mmol\u002FL (Note: The use of transfusion to achieve Hgb ≥10 g\u002FdL is acceptable) within the 28 days prior to accrual\n10. Women with child-bearing potential and using effective contraception, and not pregnant and agree not to become pregnant (see section 8.6) during participation in the trial and 30 days after radiotherapy. A negative pregnancy test before inclusion (within 28 days) into the trial is required for all women with child-bearing potential. Men agree not to father a child during participation in the trial and 30 days after radiotherapy.\n11. Written informed consent, signed by the patient and the investigator.\n\nExclusion Criteria\n\n1. Infection hampering the voice quality at the time of voice assessment\n2. Involvement of the anterior commissure by the tumor\n3. Previous oncologic surgery with curative intent (exception: excisional biopsies resulting in unacceptable close R0 or R1\u002FR2 margins may be included) or radiotherapy to larynx\n4. Synchronous or previous malignancies. Exceptions are adequately treated basal cell carcinoma or SCC of the skin, or in situ carcinoma of the cervix uteri, low-risk prostate cancer or breast with a cancer-free follow-up time of at least 3 years, or other previous malignancy with a progression-free interval of at least 5 years\n5. Co-existing disease prejudicing survival (expected survival less than 6 months)\n6. Active bacterial or fungal infection requiring intravenous antibiotics at the time of registration\n7. History of any voice disorders (not related to the SCCGL) lasting longer than 3 weeks\n8. Illness requiring hospitalization or precluding study therapy within 28 days before registration\n9. Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial",{"count":67,"type":21},34,[69],"NA","Laser surgery and radiotherapy are well-established standards of care for unilateral stage 0 \\& I carcinoma in situ (Cais) and squamous cell carcinoma of glottic larynx (SCCGL). Based on meta-analyses, functional and oncological outcome after both treatment modalities are comparable1-5. However, no properly conducted randomized trials comparing these treatments exist. The only such trial with the endpoint of voice quality had to be prematurely closed due to low accrual6.\n\nThe traditional radiotherapy involves the treatment of the whole larynx. Recently, a new radiotherapy technique was introduced by a team of researchers from Netherlands, where the treated target volume consists of involved vocal cord and therefore 8 to 10-fold smaller than the target volumes used for traditional whole larynx irradiation. The treatment is reduced to 16 fractions which corresponds to 3 weeks and a day7-12. The results of a prospective cohort (n=30) with single vocal cord irradiation (SVCI) were compared with the results of a historical prospective cohort previously treated with whole larynx radiotherapy (n=131) in the same institute. The median follow-up was 30 months. The voice handicap index (VHI) at all time points beginning from the 6th week after SVCI was significantly superior to the same time points with conventional radiotherapy. Moreover, a comparable local control with SVCI (100%) vs. conventional radiotherapy (92%) was reported at two years, p=0.2412.\n\nBased on this information, the investigators' main aim is to compare SVCI to Transoral CO2-Laser Microsurgical Cordectomy (TLM) with the main focus of patient-reported voice quality.",[72,73],"Glottis Tumor","Larynx Cancer",[75,76,77,34,78,79,80,81,82],"head and neck cancer","squamous cell carcinoma","carcinoma in situ","surgery","transoral laser microsurgery","patient reported outcome","quality of life","voice","2025-10-01",{"date":85,"type":49},"2025-10-07",{"date":87,"type":49},"2019-11-20",{"date":89,"type":21},"2030-11-30",{"name":55,"class":56},4,""]