Salvage Brachytherapy and Hyperthermia for Recurrent H&N-tumours

SALVAGE BRACHYTHERAPY WITH INTERSTITIAL HYPERTHERMIA FOR LOCALLY RECURRENT HEAD & NECK CARCINOMA FOLLOWING PREVIOUSLY EXTERNAL BEAM RADIATION THERAPY: A PROSPECTIVE PHASE II STUDY

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.

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