RecruitingNot ApplicableNCT03238378

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

Sponsor

University of Erlangen-Nürnberg Medical School

Enrollment

96 participants

Start Date

Mar 29, 2017

Study Type

INTERVENTIONAL

Conditions

Locally Recurrent Head and Neck Cancer

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

Min Age: 18 Years

Inclusion Criteria9

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 Criteria6

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

Interventions

RADIATIONBrachytherapy

Brachytherapy d 1-5(6)

OTHERHyperthermia

Hyperthermia d 2 + 5

Locations(1)

Dept. of Radiation Therapy, University Hospital Erlangen

Erlangen, Germany

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT03238378