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

Status

Recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03238378

Acronym

HyBT-H&N

Enrollment

Registered

2017-08-03

Start date

2017-03-29

Completion date

2027-12-31

Last updated

2018-06-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Locally Recurrent Head and Neck Cancer

Keywords

head and neck cancer, Locally recurrent head and neck cancer, Brachytherapy, Hyperthermia

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

Interventions

RADIATIONBrachytherapy

Brachytherapy d 1-5(6)

OTHERHyperthermia

Hyperthermia d 2 + 5

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Late side effects	Effects are followed up to 5 years after therapy	Comparison late side effects to standard therapy

Secondary

Measure	Time frame	Description
Quality of life	up to 5 years after therapy	Assessment of quality of life with EORTC questionnaires
Rate of local recurrencies	up to 5 years after therapy	Assessment of cumulative local recurrence rate
Overall survival	up to 5 years after therapy	Rate of Overall survival

Countries

Germany

Contacts

Primary ContactVratislav Strnad, MD

vratislav.strnad@uk-erlangen.de++49 9131 85

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026