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Multiparametric Imaging-based Intraoperative Navigation for Guidance of Surgical Resection and Postoperative Radiotherapy in Patients With Head-and-neck Tumors

RecruitingNAAges 18 Years - anyAllJuergen Debus
NCT05671458 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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/or biopsies) * Indication of surgical tumor resection according to multidisciplinary tumor conference * Probably indication for postoperative radiotherapy (e.g. T3/4 tumor) * Medical operability and written informed consent of the patient to undergo surgical resection (as indicated clinically) * Patient age ≥ 18 years * Karnofsky performance index ≥ 60% * For women with childbearing potential: adequate contraception * Ability of subject to understand character and individual consequences of the trial * Written informed consent to participate in this trial Exclusion Criteria: * Contraindications against radiotherapy, especially pregnant or lactating women * Refusal of the patient to take part in the study * Participation in another competing clinical study or observation period of competing trials
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What it tests

  • intraoperative navigation and creation of tumor resection maps
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Where

1 site
Department of Radiotherapy, University of Heidelberg
Heidelberg, Germany
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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