NCT03238378 Salvage Brachytherapy and Hyperthermia for Recurrent H&N-tumours
| NCT ID | NCT03238378 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Erlangen-Nürnberg Medical School |
| Condition | Locally Recurrent Head and Neck Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 96 participants |
| Start Date | 2017-03-29 |
| Primary Completion | 2022-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 96 participants in total. It began in 2017-03-29 with a primary completion date of 2022-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Vratislav Strnad, MD
PRINCIPAL INVESTIGATOR
Dept. of Radiation Therapy, University Hospital Erlangen
Frequently Asked Questions
Who can join the NCT03238378 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Locally Recurrent Head and Neck Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03238378 currently recruiting?
Yes, NCT03238378 is actively recruiting participants. Contact the research team at vratislav.strnad@uk-erlangen.de for enrollment information.
Where is the NCT03238378 trial being conducted?
This trial is being conducted at Erlangen, Germany.
Who is sponsoring the NCT03238378 clinical trial?
NCT03238378 is sponsored by University of Erlangen-Nürnberg Medical School. The principal investigator is Vratislav Strnad, MD at Dept. of Radiation Therapy, University Hospital Erlangen. The trial plans to enroll 96 participants.
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