Locally Recurrent Head and Neck CancerHyBT-H&NNCT03238378
Salvage Brachytherapy and Hyperthermia for Recurrent H&N-tumours
A study testing Brachytherapy and Hyperthermia in people with Locally Recurrent Head and Neck Cancer, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Locally Recurrent Head and Neck Cancer
- What is being tested?
- Brachytherapy and Hyperthermia
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteGermany
- Study dates
- 29 Mar 2017to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- Previous radiation therapy up to at least 50 Gy
- Previous radiation therapy completed more than 6 months ago
- Written study-specific informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Dept. of Radiation Therapy, University Hospital Erlangen
Erlangen, 91054
Vratislav Strnad, MD, vratislav.strnad@uk-erlangen.de
About this study
Official title: SALVAGE BRACHYTHERAPY WITH INTERSTITIAL HYPERTHERMIA FOR LOCALLY RECURRENT HEAD & NECK CARCINOMA FOLLOWING PREVIOUSLY EXTERNAL BEAM RADIATION THERAPY: A PROSPECTIVE PHASE II STUDY
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
- Locally Recurrent Head and Neck Cancer
- Being tested
- Brachytherapy, Hyperthermia
- Keywords
- head and neck cancer, Locally recurrent head and neck cancer, Brachytherapy, Hyperthermia
- Medical subject headings
- Head and Neck Neoplasms, Hyperthermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BrachytherapyRadiation
Brachytherapy d 1-5(6)
HyperthermiaOther
Hyperthermia d 2 + 5
| Study group | Role | What they receive |
|---|---|---|
| Therapy | Experimental | Brachytherapy d1-5(6) Hyperthermia d2 + 5 Receives: Radiation: Brachytherapy; Other: Hyperthermia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Late side effects
Comparison late side effects to standard therapy
Measured: Effects are followed up to 5 years after therapy
Secondary outcomes (3)
Quality of life
Assessment of quality of life with EORTC questionnaires
Measured: up to 5 years after therapy
Rate of local recurrencies
Assessment of cumulative local recurrence rate
Measured: up to 5 years after therapy
Overall survival
Rate of Overall survival
Measured: up to 5 years after therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2017
- Study start29 Mar 2017
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Recurrent Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by University of Erlangen-Nürnberg Medical SchoolThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Erlangen-Nürnberg Medical School
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vratislav Strnad, University of Erlangen-Nürnberg Medical School
- Investigators
- Vratislav Strnad, MD, Principal investigator, Dept. of Radiation Therapy, University Hospital Erlangen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03238378
- Sponsor's protocol ID
- HyBT-H&N
- Acronym
- HyBT-H&N
- Status last verified
- Jun 2018
- First submitted
- 31 Jul 2017
- Last updated
- 8 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SALVAGE BRACHYTHERAPY WITH INTERSTITIAL HYPERTHERMIA FOR LOCALLY RECURRENT HEAD & NECK CARCINOMA FOLLOWING PREVIOUSLY EXTERNAL BEAM RADIATION THERAPY: A PROSPECTIVE PHASE II STUDY
- ClinicalTrials.gov ID
- NCT03238378
- Acronym / sponsor ID
- HyBT-H&N / HyBT-H&N
- Conditions
- Locally Recurrent Head and Neck Cancer
- Keywords
- head and neck cancer, Locally recurrent head and neck cancer, Brachytherapy, Hyperthermia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- University of Erlangen-Nürnberg Medical SchoolUniversity, hospital or other
- Study start
- 29 Mar 2017 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 3 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Therapy | Experimental | Radiation: Brachytherapy, Other: HyperthermiaBrachytherapy d1-5(6) Hyperthermia d2 + 5 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BrachytherapyBrachytherapy d 1-5(6) | Radiation | Therapy |
| HyperthermiaHyperthermia d 2 + 5 | Other | Therapy |
Primary outcome
Late side effects
Time frame: Effects are followed up to 5 years after therapy
Comparison late side effects to standard therapy
3 secondary outcomes
Quality of life
Time frame: up to 5 years after therapy
Rate of local recurrencies
Time frame: up to 5 years after therapy
Overall survival
Time frame: up to 5 years after therapy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Vratislav Strnad, MD principal investigator
Dept. of Radiation Therapy, University Hospital Erlangen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brachytherapy and Hyperthermia in people with Locally Recurrent Head and Neck Cancer, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Vratislav Strnad, MD (++49 9131 85 ext. 33968, vratislav.strnad@uk-erlangen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Late side effects (time frame: Effects are followed up to 5 years after therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2018; AzTrials last refreshed its copy on 7 Nov 2026.