Head and Neck NeoplasmsNCT05412849
Radiation Field, Dose and Fractionation Related to Mandibular Complications
An observational study of Head and Neck Neoplasms and Osteoradionecrosis, run by Lund University Hospital at 1 site in Sweden.
Trial summary
Radiotherapy is inhibiting the healing capacity of the mandibular bone. Late complications as bone exposure, fracture of the jaw, osteoradionecrosis might be a consequence of this vulnerability. A factor that could be involved in the development of complications is field of radiation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Neoplasms, Osteoradionecrosis, Radiotherapy; Complications
- What is being tested?
- Radiotherapy
- Type of treatment
- Surgery or procedure
- How many people
- 120 participants
- Where
- 1 siteSweden
- Study dates
- 1 Jan 2023to Jul 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- Adult, Older adult
Study population: Consecutively included patients treated for head and neck neoplasms with a combination of surgery and radiotherapy.
Who may be able to join
- Clinical diagnosis of the head and neck malignancy
- Must have recieved radiotherapy as primary treatment alone or combination treatment together with surgery
Who cannot join
- less than 12 months follow up
- Under 18 years of age
Trial locations and contacts
1 site in 1 country.
Sweden1 site, 1 recruiting
- Recruiting
Skane University Hospital
Lund
Philip Fransson, Msc, 0046 (0)761077255, philip.fransson@gmail.com
About this study
Official title: Is the Radiation Field, Dose and Fractionation Crucial for the Development of Mandibular Complications When Treating Malignancies in the Oropharyngeal Region?
Radiotherapy is inhibiting the healing capacity of the mandibular bone. Late complications as bone exposure, fracture of the jaw, osteoradionecrosis might be a consequence of this vulnerability. A factor that could be involved in the development of complications is field of radiation. There are limited number of studies investigating this relation.
Retrospective analysis of a head and neck oncology register with prospectively included patients will be performed. Patients will be related to the University hospitals in Lund, Umea, Orebro, Stockholm. A thorough analysis of the medical journals in this group of patients will be performed. Included patients have been treated with combination of surgery and radiotherapy to treat malignancies in the head and neck region. At least 12 months follow up period is needed for inclusion.
The scientific aim is to investigate weather the field of radiation and fractionation is crucial for developing the formentioned complications.
- Being tested
- Radiotherapy
- Medical subject headings
- Head and Neck Neoplasms, Osteoradionecrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RadiotherapyRadiation
Radiotherapy site, time perspective and dose
What is being measured
The primary outcome is the main question the study is designed to answer.
Complications related to dose, time and position of radiotherapy
Complications as Osteoradionecrosis will be identified and compared with the dose of radiation, how long ago since the radiotherapy was given and where in the mouth the complication has developed.
Measured: The measurements will be done from the end of radiotherapy and atleast 1 year postoperatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2022
- Study start1 Jan 2023
- Primary completionJan 2025 (estimated)
- Study completionJul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck NeoplasmsStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lund University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Martin Bengtsson, PhD, Principal investigator, Lund University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05412849
- Sponsor's protocol ID
- LundUH
- Status last verified
- May 2024
- First submitted
- 8 Feb 2022
- Last updated
- 23 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is the Radiation Field, Dose and Fractionation Crucial for the Development of Mandibular Complications When Treating Malignancies in the Oropharyngeal Region?
- ClinicalTrials.gov ID
- NCT05412849
- Acronym / sponsor ID
- LundUH
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Lund University HospitalUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- Jan 2025 (estimated)
- Study completion
- Jul 2025 (estimated)
- First posted
- 9 Jun 2022 (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.
Radiotherapy is inhibiting the healing capacity of the mandibular bone. Late complications as bone exposure, fracture of the jaw, osteoradionecrosis might be a consequence of this vulnerability. A factor that could be involved in the development of complications is field of radiation. There are limited number of studies investigating this relation.
Retrospective analysis of a head and neck oncology register with prospectively included patients will be performed. Patients will be related to the University hospitals in Lund, Umea, Orebro, Stockholm. A thorough analysis of the medical journals in this group of patients will be performed. Included patients have been treated with combination of surgery and radiotherapy to treat malignancies in the head and neck region. At least 12 months follow up period is needed for inclusion.
The scientific aim is to investigate weather the field of radiation and fractionation is crucial for developing the formentioned complications.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Consecutively included patients treated for head and neck neoplasms with a combination of surgery and radiotherapy.
Key inclusion criteria (2 listed)
- Clinical diagnosis of the head and neck malignancy
- Must have recieved radiotherapy as primary treatment alone or combination treatment together with surgery
Key exclusion criteria (2 listed)
- less than 12 months follow up
- Under 18 years of age
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 |
|---|---|---|
| RadiotherapyRadiotherapy site, time perspective and dose | Radiation | – |
Primary outcome
Complications related to dose, time and position of radiotherapy
Time frame: The measurements will be done from the end of radiotherapy and atleast 1 year postoperatively.
Complications as Osteoradionecrosis will be identified and compared with the dose of radiation, how long ago since the radiotherapy was given and where in the mouth the complication has developed.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2024.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Martin Bengtsson, PhD principal investigator
Lund University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Head and Neck Neoplasms and Osteoradionecrosis, run by Lund University Hospital at 1 site in Sweden.
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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 23 May 2024. 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 Sweden. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Philip Fransson, Msc (0046 761077255, philip.fransson@skane.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complications related to dose, time and position of radiotherapy (time frame: The measurements will be done from the end of radiotherapy and atleast 1 year postoperatively.). 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 23 May 2024.