Status:
RECRUITING
Salvage Brachytherapy and Hyperthermia for Recurrent H&N-tumours
Lead Sponsor:
University of Erlangen-Nürnberg Medical School
Conditions:
Locally Recurrent Head and Neck Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 patien...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 29 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
96 Patients enrolled
Trial Details
Trial ID
NCT03238378
Start Date
March 29 2017
End Date
December 31 2027
Last Update
June 8 2018
Active Locations (1)
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1
Dept. of Radiation Therapy, University Hospital Erlangen
Erlangen, Germany, 91054