RecruitingNot ApplicableNCT03238378

Salvage Brachytherapy and Hyperthermia for Recurrent H&N-tumours

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


Sponsor

University of Erlangen-Nürnberg Medical School

Enrollment

96 participants

Start Date

Mar 29, 2017

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of internal radiation therapy (brachytherapy) and heat treatment (hyperthermia) for people whose head and neck cancer has come back after previous radiation treatment. **You may be eligible if...** - You have been confirmed (by biopsy) to have a recurrent (returned) cancer in the head and neck region - Your cancer is an early to intermediate stage (rcT1–T3) and has not spread to distant organs - You previously received radiation therapy of at least 50 Gy, finished more than 6 months ago - You are in reasonably good physical condition (ECOG score 0–2) **You may NOT be eligible if...** - Your tumor is a very advanced stage (T4) - You have significant lymph node involvement with certain features - You are pregnant or breastfeeding - You have a collagen vascular disease or a genetic condition that makes you very sensitive to radiation (such as Ataxia Telangiectasia) - You have a psychiatric disorder Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONBrachytherapy

Brachytherapy d 1-5(6)

OTHERHyperthermia

Hyperthermia d 2 + 5


Locations(1)

Dept. of Radiation Therapy, University Hospital Erlangen

Erlangen, Germany

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NCT03238378