Clinical trial · Interventional
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
NCT03238378CI-TRIAL-00033254HyBT-H&NrecruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Locally Recurrent Head and Neck Cancer | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Brachytherapy | Radiation | — | UNRESOLVED |
| Hyperthermia | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Therapy
- description
- Brachytherapy d1-5(6) Hyperthermia d2 + 5
- interventionNames
- Radiation: Brachytherapy
- Other: Hyperthermia
Primary outcomes (1)
- measure
- Late side effects
- timeFrame
- Effects are followed up to 5 years after therapy
- description
- Comparison late side effects to standard therapy
Secondary outcomes (3)
- measure
- Quality of life
- timeFrame
- up to 5 years after therapy
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.