Salvage Brachytherapy and Hyperthermia for Recurrent H&N-tumours

Not Applicable

Recruiting

• Conditions: Locally Recurrent Head and Neck Cancer
• Interventions: Radiation: Brachytherapy; Other: Hyperthermia

• Registration Number: NCT03238378
• Lead Sponsor: University of Erlangen-Nürnberg Medical School

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-03-29
• Study First Submitted: 2017-07-31
• Study First Submitted QC: 2017-07-31
• Study First Posted: 2017-08-03
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-06
• Last Update Posted: 2018-06-08
• Primary Completion: 2022-12-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 96

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Therapy	Brachytherapy	Brachytherapy d1-5(6) Hyperthermia d2 + 5
Therapy	Hyperthermia	Brachytherapy d1-5(6) Hyperthermia d2 + 5

Primary Outcome Measures

Name	Time	Method
Late side effects	Effects are followed up to 5 years after therapy	Comparison late side effects to standard therapy

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Dept. of Radiation Therapy, University Hospital Erlangen; 🇩🇪 Erlangen, Germany