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Salvage Brachytherapy and Hyperthermia for Recurrent H&N-tumours

Recruiting
18 years of age
Both
Phase N/A

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Overview

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.

Eligibility

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

Study details

Locally Recurrent Head and Neck Cancer

NCT03238378

University of Erlangen-Nürnberg Medical School

28 January 2024

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