NCT03238378Recruiting
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
Source: ClinicalTrials.gov · Last updated 8 Jun 2018 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 96 (estimated)
- First submitted
- 31 Jul 2017
- Start date
- 29 Mar 2017
- Primary completion date
- 31 Dec 2022
- Lead sponsor
- University of Erlangen-Nürnberg Medical School
- Diseases
- Head and neck cancer
- NCT number
- NCT03238378
What you commit to
- Study type: Interventional
- Planned participants: 96
- From 29 Mar 2017 to the primary completion date, 31 Dec 2022
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Collagen vascular disease
- The presence of congenital diseases with increased radiation sensitivity, for example Ataxia telangiectatica or similar
- Psychiatric disorders
Other
- cT4
- rpN+ with \>2 pos. LND or invasion of capsula
- Pregnant or lactating women
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Dept. of Radiation Therapy, University Hospital Erlangen Coordinator of this site? Confirm its status | Erlangen | Germany | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.