Salvage Brachytherapy and Hyperthermia for Recurrent H&N-tumours (HyBT-H&N)

University of Erlangen-Nürnberg Medical School

Status: Enrolling

Conditions: Locally Recurrent Head and Neck Cancer

Treatments: Other: Hyperthermia; Radiation: Brachytherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03238378

HyBT-H&N

Details and patient eligibility

About

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.

Enrollment: 96 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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96 participants in 1 patient group

Therapy

Experimental group

Description:

Brachytherapy d1-5(6) Hyperthermia d2 + 5

Treatment:

Other: Hyperthermia

Radiation: Brachytherapy