HyBT-H&N
Salvage Brachytherapy and Hyperthermia for Recurrent H&N-tumours
Rekrutierend
NCT-Nummer:
NCT03238378
Studienbeginn:
März 2017
Letztes Update:
08.06.2018
Wirkstoff:
-
Indikation (Clinical Trials):
Head and Neck Neoplasms, Recurrence, Hyperthermia, Fever
Geschlecht:
Alle
Altersgruppe:
Erwachsene (18+)
Phase:
-
Sponsor:
University of Erlangen-Nürnberg Medical School
Collaborator:
-
Studienleiter
Vratislav Strnad, MD
Principal Investigator
Dept. of Radiation Therapy, University Hospital Erlangen
Kontakt
Vratislav Strnad, MD
Kontakt:
Phone: ++49 9131 85
Phone (ext.): 33968
E-Mail: vratislav.strnad@uk-erlangen.de» Kontaktdaten anzeigen
Brief 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.
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
Primary outcome:
1. Late side effects (Time Frame - Effects are followed up to 5 years after therapy):
Comparison late side effects to standard therapy
Secondary outcome:
1. Quality of life (Time Frame - up to 5 years after therapy):
Assessment of quality of life with EORTC questionnaires
2. Rate of local recurrencies (Time Frame - up to 5 years after therapy):
Assessment of cumulative local recurrence rate
3. Overall survival (Time Frame - up to 5 years after therapy):
Rate of Overall survival
- Brachytherapy:
Brachytherapy d 1-5(6) - Hyperthermia:
Hyperthermia d 2 + 5
Quelle: ClinicalTrials.gov
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