Salvage Brachytherapy and Hyperthermia for Recurrent H&N-tumours

University of Erlangen-Nürnberg Medical School96 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Locally Recurrent Head and Neck Cancer

Interventions

BrachytherapyRADIATION

Brachytherapy d 1-5(6)

HyperthermiaOTHER

Hyperthermia d 2 + 5

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Dept. of Radiation Therapy, University Hospital Erlangen

Erlangen, Germany

RECRUITING

Outcomes

Primary Outcomes

Late side effects

Comparison late side effects to standard therapy

Time frame: Effects are followed up to 5 years after therapy

Secondary Outcomes

Quality of life

Assessment of quality of life with EORTC questionnaires

Time frame: up to 5 years after therapy

Rate of local recurrencies

Assessment of cumulative local recurrence rate

Time frame: up to 5 years after therapy

Overall survival

Rate of Overall survival

Time frame: up to 5 years after therapy

Central Contacts

Vratislav Strnad, MD

CONTACT

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

Data from ClinicalTrials.gov

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