Treatment for recurrent head and neck cancer using brachytherapy and hyperthermia
Official title: SALVAGE BRACHYTHERAPY WITH INTERSTITIAL HYPERTHERMIA FOR LOCALLY RECURRENT HEAD & NECK CARCINOMA FOLLOWING PREVIOUSLY EXTERNAL BEAM RADIATION THERAPY: A PROSPECTIVE PHASE II STUDY
Run by University of Erlangen-Nürnberg Medical School · NCT03238378 · Data updated 2026-11-12
This study is testing a new treatment that combines a special type of radiation and heat therapy for people with recurring head and neck cancer who can't have surgery.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 96 (estimated) |
| Sponsor | University of Erlangen-Nürnberg Medical School Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Erlangen) |
| Status | Recruiting |
| Started | March 29, 2017 |
| Main results expected | December 31, 2022 |
| Study ends | December 31, 2027 |
| Registry record updated | June 8, 2018 |
| Trial ID | NCT03238378 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include individuals with histologically confirmed recurrent head and neck carcinoma at stages rcT1-3, who have previously undergone radiation therapy and meet specific tumor and health criteria.
✕Probably not a fit
Patients with advanced stage tumors (cT4), significant lymph node involvement, or those with certain medical conditions may not benefit from this treatment.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This trial aims to evaluate the effectiveness of interstitial pulsed-dose-rate (PDR) brachytherapy combined with interstitial hyperthermia in patients with locally recurrent head and neck cancer who are not candidates for salvage surgery. The study focuses on patients with specific tumor characteristics and prior treatment history, ensuring that the selected individuals are suitable for this innovative approach. By utilizing these two modalities, the trial seeks to improve local control of the cancer and potentially enhance patient outcomes.
Why it matters
Potential benefit: If successful, this treatment could provide a new option for patients with recurrent head and neck cancer who have limited surgical options.
How similar studies have gone: While the combination of brachytherapy and hyperthermia is a promising approach, the specific application in this context is relatively novel and has not been extensively tested in prior studies.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Dept. of Radiation Therapy, University Hospital Erlangen
Erlangen, Germany Recruiting
Study contacts
- Principal investigator: Vratislav Strnad, MD — Dept. of Radiation Therapy, University Hospital Erlangen
- Study coordinator: Vratislav Strnad, MD
- Email: vratislav.strnad@uk-erlangen.de
- Phone: ++49 9131 85
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.