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Salvage Brachytherapy and Hyperthermia for Recurrent H&N-tumours

RECRUITINGN/ASponsored by University of Erlangen-Nürnberg Medical School
Actively Recruiting
PhaseN/A
SponsorUniversity of Erlangen-Nürnberg Medical School
Started2017-03-29
Est. completion2022-12-31
Eligibility
Age18 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT03238378

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 patients where salvage surgery with clear resection margins was not possible.

Eligibility

Age: 18 Years+Healthy volunteers accepted
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

Conditions2

CancerLocally Recurrent Head and Neck Cancer

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