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New treatment option for Locally Recurrent Head and Neck Cancer
Official title Salvage Brachytherapy and Hyperthermia for Recurrent H&N-tumours
ClinicalTrials.gov ID: NCT03238378
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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.
- ECOG 0-2
You likely can't join if
- 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
See the full eligibility 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.
- 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Erlangen, Germany
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Erlangen, Germany. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.