[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Juergen Debus\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":89},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,41,68],{"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":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100527053","mr-guidance-in-chemoradiotherapy-for-cervical-cancer-100527053",false,"NCT06142760","MR-guidance in Chemoradiotherapy for Cervical Cancer","Daily AI-based Treatment Adaptation Under Weekly Offline MR-guidance in Chemoradiotherapy for Cervical Cancer 1 AIM-C1","AIM-C1","Inclusion Criteria:\n\n* biopsy-proven cervical cancer including squamous-cell carcinoma, adenocarcinoma or adeno-squamous cell carcinoma\n* FIGO stage IB, IIA, IIB, IIIA, IIIB, IIIC1\n* indication and eligibility for definitive chemoradiotherapy including brachytherapy discussed in an interdisciplinary tumor board\n* Karnofsky performance score ≥ 70%\n* 18-80 years of age\n* Capacity of the patient to consent to participation in the study\n\nExclusion Criteria:\n\n* FIGO stage IIIC2 and IV\n* Paraaortic lymphatic node metastases\n* small cell neuroendocrine cancer, melanoma and other rare cancers of the cervix\n* previous radiotherapy of the pelvic region\n* previous total or partial hysterectomy\n* neoadjuvant chemotherapy\n* contraindications against performing contrast-enhanced MRI scans (pacemakers, other implants making MRI impossible, allergy to gadolinium (GD)-based contrast agent)\n* claustrophobia\n* pregnant or lactating women\n* other primary malignancies within 5 years before except carcinoma in situ of the cervix and basal cell carcinoma of the skin\n* patient is enrolled in another study, that could influence the outcome of the presented study","ALL","18 Years",{"count":20,"type":21},40,"ESTIMATED","INTERVENTIONAL",[24],"NA","Concurrent chemoradiotherapy (CCRT), consisting of external beam radiotherapy (EBRT) and chemotherapy, followed by brachytherapy (BT) is the standard of care for patients with locally advanced cervical carcinoma. In current clinical practice, conventionally, one radiotherapy plan based on the initial planning computed tomography (CT) and magnetic resonance imaging (MRI) scan of the pelvis is applied for the complete 5-6 weeks of EBRT. However, there is a high degree of cervix and uterus motion in the pelvis due to different fillings of the bladder and the bowel. Consequently, large safety margins are required to compensate for organ movement, potentially leading to higher toxicity. Lately, daily high-quality cone-beam CT (CBCT) guided adaptive radiotherapy, aided by artificial intelligence (AI), became clinically available. Due to the improved soft-tissue contrast, the treatment plan can now be online adapted to the current position of the tumor and the adjacent organs-at-risk (OAR), while the patient is lying on the treatment couch. Moreover, the German Research Cancer Center offers the unique possibility of additional weekly magnetic resonance imaging (MRI) in treatment position using a shuttle system. Daily CBCT-adapted EBRT in combination with weekly MRI in treatment position might therefore offer superior sparing of surrounding OAR and consequently reduction of treatment-associated side-effects.\n\nHowever, to the investigators knowledge, no toxicity data for daily CBCT\u002FAI adaptive EBRT of locally advanced cervical cancer with additional MR-guidance exists. The AIM-C1 trial therefore aims to assess the potential of daily CBCT adaptive and AI aided EBRT combined with additional weekly offline MR-guidance in treatment position using a shuttle system.",[27],"Cervical Cancer","RECRUITING","2026-03-06",{"date":31,"type":32},"2026-03-09","ACTUAL",{"date":34,"type":32},"2023-11-15",{"date":36,"type":21},"2027-05-01",{"name":38,"class":39},"Juergen Debus","OTHER",1,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":49,"minAge":18,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":22,"phases":52,"briefSummary":53,"conditions":54,"keywords":56,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":40},"100369754","intrafractional-vaginal-dilation-in-anal-cancer-patients-undergoing-pelvic-radiotherapy-100369754","NCT04094454","Intrafractional Vaginal Dilation in Anal Cancer Patients Undergoing Pelvic Radiotherapy","Intrafractional Vaginal Dilation in Anal Cancer Patients Undergoing Pelvic Radiotherapy - Prospective, Randomized, Two-armed Phase-II-study","DILANA","Inclusion Criteria:\n\n* Female patient\n* Histologically confirmed squamous anal cancer\n* Indication for definitive or postoperative radiotherapy\n* ECOG 0-2\n* Age \\> 18 years\n* Written informed consent\n\nExclusion Criteria:\n\n* patients refusal or incapability of informed consent\n* no vaginal dilatation possible prior to radiation treatment start\n* prior pelvic irradiation (if direct field border or even overlap of radiation fields assumed)\n* participation in another clinical trial which might influence the results of the DILANA trial\n* pregnancy\u002Fnursing period or inadequate contraception in women with child bearing potential","FEMALE",{"count":51,"type":21},60,[24],"A commercially available vaginal dilator set will be used as measuring device. The grading of vaginal stenosis will be determined as difference of the diameter of vaginal dilator to the baseline. A reduction of the diameter of \\\u003C20% is defined as vaginal stenosis Grade 1, a reduction of 20-35% as Grade 2, a reduction of \\>35-49% as Grade 3 and a reduction \\>\u002F=50% as Grade 4. The investigators hypothesize that the rate of vaginal stenosis Grade 1 or higher 12 months after radiotherapy is lower in the group using extended vaginal dilation during radiotherapy (Arm A). Rates of vaginal stenosis of 50% have been observed in previous patient collectives and the investigators hypothesize that a reduction to 25% is possible in the experimental group.",[55],"Anal Cancer",[57,58,59,60],"female patients","quality of life","vaginal dilator","vaginal fibrosis",{"date":62,"type":32},"2026-03-10",{"date":64,"type":32},"2019-10-01",{"date":66,"type":21},"2027-04",{"name":38,"class":39},{"id":69,"slug":70,"hasResults":11,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":74,"eligibilityCriteria":75,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":76,"targetDuration":4,"studyType":22,"phases":77,"briefSummary":78,"conditions":79,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":40},"100490848","multiparametric-imaging-based-intraoperative-navigation-for-guidance-of-surgical-resection-and-postoperative-radiotherapy-in-patients-with-head-and-neck-tumors-100490848","NCT05671458","Multiparametric Imaging-based Intraoperative Navigation for Guidance of Surgical Resection and Postoperative Radiotherapy in Patients With Head-and-neck Tumors","Multiparametric Imaging-based Intraoperative Navigation for Guidance of Surgical Resection and Postoperative Radiotherapy in Patients With Head-and-neck Tumors - NAVIGATORR","NAVIGATORR","Inclusion Criteria:\n\n* Diagnosis of a malignancy (squamous cell carcinoma (SCC), adenocarcinoma (AC), mucoepidermoid carcinoma (MEC), adenoidcystic carcinoma (ACC)) of the midface, upper jaw and skull-base (e.g. based on imaging-studies and\u002For biopsies)\n* Indication of surgical tumor resection according to multidisciplinary tumor conference\n* Probably indication for postoperative radiotherapy (e.g. T3\u002F4 tumor)\n* Medical operability and written informed consent of the patient to undergo surgical resection (as indicated clinically)\n* Patient age ≥ 18 years\n* Karnofsky performance index ≥ 60%\n* For women with childbearing potential: adequate contraception\n* Ability of subject to understand character and individual consequences of the trial\n* Written informed consent to participate in this trial\n\nExclusion Criteria:\n\n* Contraindications against radiotherapy, especially pregnant or lactating women\n* Refusal of the patient to take part in the study\n* Participation in another competing clinical study or observation period of competing trials",{"count":51,"type":21},[24],"The overarching goal of the NAVIGATORR trial is the improvement of local tumor control in head-and-neck cancer (HNC) by increasing the precision of surgical resection and individualization of radiotherapy. Squamous cell carcinomas (SCC) together with salivary gland carcinomas (adenoid cysytic Carcinoma (ACC), mucoepidermoid Carcinoma (MEC), adenocarcinoma (AC)) represent the most common entities in German head and neck oncology. In localized tumors, primary tumor resection with possible adjuvant (chemo)radiotherapy is still the treatment of choice. Advances in targeted therapy and immunotherapy have greatly expanded the repertoire of medical oncology in recent years. In particular, prognosis of patients with end-stage non-small cell lung cancer (NSCLC) has been improved and even patients with advanced head and neck disease can be offered new second line regimes. Importantly, all of these advances are based on personalized and targeted therapies. Unfortunately, surgical oncology in the head-and-neck region has not yet shown such developments towards individualized treatment, so that the rates of safe oncological resections (clear resection margins) haven been stagnating. Despite advances in reconstructive surgery that allow the resection of head-and-neck tumors that would not have been operable 10 - 15 years ago, the basic principles of the resection margin and especially margin evaluation have remained unchanged. The technique of navigation-based tumor resection and the annotation of biopsies by titanium clip-markings or special annotation have been described, but only in small case series and without proving the benefit of the method concerning clinically relevant parameters.\n\nTherefore, the NAVIGATORR trial will enroll 60 patients with HNC of the midface that will undergo navigation-based surgery. Importantly, interdisciplinary data exchange of the intraoperative navigation data between surgeons, pathologists and radiation oncologists will be established. Clear surgical margins (distance between tumor cells and resection border \\> 5 mm) have been defined as primary endpoint. Secondary endpoints such as dosimetric assessment of individualized radiotherapy plans, local tumor control or overall survival should then be compared to data from the literature to further assess this multidisciplinary approach.",[80],"Head and Neck Tumors","2026-01-08",{"date":83,"type":32},"2026-01-12",{"date":85,"type":32},"2023-01-01",{"date":87,"type":21},"2027-01-01",{"name":38,"class":39},""]