Salvage Brachytherapy and Hyperthermia for Recurrent H&N-tumours
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Brachytherapy, Hyperthermia.
- Who it may be relevant to
- Registry conditions: Locally Recurrent Head and Neck Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
SALVAGE BRACHYTHERAPY WITH INTERSTITIAL HYPERTHERMIA FOR LOCALLY RECURRENT HEAD & NECK CARCINOMA FOLLOWING PREVIOUSLY EXTERNAL BEAM RADIATION THERAPY: A PROSPECTIVE PHASE II STUDY
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.
Interventions
- Radiation Brachytherapy
Brachytherapy d 1-5(6) - Other Hyperthermia
Hyperthermia d 2 + 5
Primary outcome measures
- Late side effects [Time frame: Effects are followed up to 5 years after therapy]
Secondary outcome measures (3)
- Quality of life [Time frame: up to 5 years after therapy]
- Rate of local recurrencies [Time frame: up to 5 years after therapy]
- Overall survival [Time frame: up to 5 years after therapy]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Germany · 1 center
- Dept. of Radiation Therapy, University Hospital Erlangen — Erlangen
Identifiers
NCT: NCT03238378 · HyBT-H&N