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Salvage Brachytherapy and Hyperthermia for Recurrent H&N-tumours

RecruitingNAAges 18 Years - anyAllUniversity of Erlangen-Nürnberg Medical School
NCT03238378 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The aim of the present trial is to assess the prospective results of protocol-based interstitial pulsed-dose-rate (PDR) brachytherapy with interstitial hyperthermia (iHT) in a group of selected patients where salvage surgery with clear resection margins was not possible.

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📋 Eligibility rules (as published)
Inclusion Criteria: * Histologically confirmed recurrent carcinoma of the head and neck region * Stage rcT1-3 * Tumor anatomy and location suitable for brachytherapy techniques. * cN0/pN0 or rpN+ \& R0 with \<3 pos. LND \& without invasion of capsula. * M0 * ECOG 0-2 * Previous radiation therapy up to at least 50 Gy * Previous radiation therapy completed more than 6 months ago * Written study-specific informed consent Exclusion Criteria: * cT4 * rpN+ with \>2 pos. LND or invasion of capsula * Pregnant or lactating women * Collagen vascular disease * The presence of congenital diseases with increased radiation sensitivity, for example Ataxia telangiectatica or similar * Psychiatric disorders
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What it tests

  • Brachytherapy
  • Hyperthermia
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Where

1 site
Dept. of Radiation Therapy, University Hospital Erlangen
Erlangen, 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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