Salvage Brachytherapy and Hyperthermia for Recurrent H&N-tumours

Locally Recurrent Head and Neck Cancer Clinical Trial

— HyBT-H&N  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03238378
• Other study ID #: HyBT-H&N
• Status: Recruiting
• Phase: N/A
• Start date: March 29, 2017
• Est. completion date: December 31, 2027

Study information

• Verified date: June 2018
• Source: University of Erlangen-Nürnberg Medical School
• Contact: Vratislav Strnad, MD
• Phone: ++49 9131 85
• Email: vratislav.strnad[@]uk-erlangen.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 96
• Est. completion date: December 31, 2027
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fever
• Head and Neck Neoplasms
• Locally Recurrent Head and Neck Cancer

Intervention

Radiation:
• Brachytherapy
Brachytherapy d 1-5(6)

Other:
• Hyperthermia
Hyperthermia d 2 + 5

Locations

Country	Name	City	State
Germany	Dept. of Radiation Therapy, University Hospital Erlangen	Erlangen

Sponsors (1)

Lead Sponsor	Collaborator
University of Erlangen-Nürnberg Medical School

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Late side effects	Comparison late side effects to standard therapy	Effects are followed up to 5 years after therapy
Secondary	Quality of life	Assessment of quality of life with EORTC questionnaires	up to 5 years after therapy
Secondary	Rate of local recurrencies	Assessment of cumulative local recurrence rate	up to 5 years after therapy
Secondary	Overall survival	Rate of Overall survival	up to 5 years after therapy