Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT03238378

Salvage Brachytherapy and Hyperthermia for Recurrent H&N-tumours

Led by University of Erlangen-Nürnberg Medical School · Updated on 2018-06-08

96

Participants Needed

1

Research Sites

561 weeks

Total Duration

On this page

AI-Summary

What this Trial Is 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.

CONDITIONS

Official Title

Salvage Brachytherapy and Hyperthermia for Recurrent H&N-tumours

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Histologically confirmed recurrent carcinoma of the head and neck region
  • Tumor stage rcT1-3
  • Tumor anatomy and location suitable for brachytherapy techniques
  • No or limited lymph node involvement (cN0/pN0 or rpN+ with R0 and fewer than 3 positive lymph nodes without capsule invasion)
  • No distant metastasis (M0)
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
  • Previous radiation therapy of at least 50 Gy completed more than 6 months ago
  • Provided written informed consent for the study
Not Eligible

You will not qualify if you...

  • Tumor stage cT4
  • More extensive lymph node involvement (rpN+ with more than 2 positive lymph nodes or capsule invasion)
  • Pregnant or breastfeeding women
  • Presence of collagen vascular disease
  • Congenital diseases with increased radiation sensitivity, such as Ataxia telangiectasia or similar
  • Psychiatric disorders

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Dept. of Radiation Therapy, University Hospital Erlangen

Erlangen, Germany, 91054

Actively Recruiting

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Research Team

V

Vratislav Strnad, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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