Osteoradionecrosis of JawOPENNCT04097847
Osteoradionecrosis and PENTOCLO Protocol: Retrospective Study
An observational study of Osteoradionecrosis of Jaw, run by University Hospital, Brest at 1 site in France.
Trial summary
osteoradionecrosis (ORN) affects up to 30% of irradiated patients and can occur up to several decades after stopping treatment. Differents therapeutics exist but there is no consensus concerning the management of the maxillary ORN. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoradionecrosis of Jaw
- What is being tested?
- Pentoxifylline-Tocopherol-Clodronate
- How many people
- 96 participants
- Where
- 1 siteFrance
- Study dates
- 2 Jun 2017to 1 Apr 2019
- 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
- No healthy volunteers
- Adult, Older adult
Study population: all patients treated at Brest hospital University for ENT cancer and who had cervicofacial radiotherapy, with maxillary and / or mandibular osteoradionecrosis treated with PENTOCLO alone or in combination with other therapies
Who may be able to join
- Patient over 18 being or having been treated by pentoclo combination for an osteoradionecrosis of the jaw
Who cannot join
- Tumoral recidivism
- Precocious stop of pentoclo
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Osteoradionecrosis and PENTOCLO Protocol: Retrospective Study.
osteoradionecrosis (ORN) affects up to 30% of irradiated patients and can occur up to several decades after stopping treatment. Differents therapeutics exist but there is no consensus concerning the management of the maxillary ORN. The understanding of new pathological mechanisms opens the way to new therapeutic perspectives.
- Conditions
- Osteoradionecrosis of Jaw
- Being tested
- Pentoxifylline-Tocopherol-Clodronate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pentoxifylline-Tocopherol-ClodronateDrug
Also called Pentoclo
the aim of this retrospective study is to analyze from patient records the impact of the PENTOCLO protocol on maxillofacial osteoradionecrosis at Brest Hospital University, France.
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical evolution of the osteoradionecrosis lesion after introducing PENTOCLO protocol
Retrospective study based on recovering patient data from medical records
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2019
- Study start2 Jun 2017
- Primary completion1 Apr 2019
- Study completion1 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoradionecrosis of JawStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04097847
- Sponsor's protocol ID
- OPEN (29BRC17.0115)
- Acronym
- OPEN
- Status last verified
- Feb 2019
- First submitted
- 14 May 2019
- Last updated
- 1 Nov 2019
- 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 1 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Osteoradionecrosis and PENTOCLO Protocol: Retrospective Study.
- ClinicalTrials.gov ID
- NCT04097847
- Acronym / sponsor ID
- OPEN / OPEN (29BRC17.0115)
- Conditions
- Osteoradionecrosis of Jaw
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 2 Jun 2017 (actual)
- Primary completion
- 1 Apr 2019 (actual)
- Study completion
- 1 Apr 2019 (actual)
- First posted
- 20 Sep 2019 (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.
osteoradionecrosis (ORN) affects up to 30% of irradiated patients and can occur up to several decades after stopping treatment. Differents therapeutics exist but there is no consensus concerning the management of the maxillary ORN. The understanding of new pathological mechanisms opens the way to new therapeutic perspectives.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- all patients treated at Brest hospital University for ENT cancer and who had cervicofacial radiotherapy, with maxillary and / or mandibular osteoradionecrosis treated with PENTOCLO alone or in combination with other therapies
Key inclusion criteria (1 listed)
- Patient over 18 being or having been treated by pentoclo combination for an osteoradionecrosis of the jaw
Key exclusion criteria (2 listed)
- Tumoral recidivism
- Precocious stop of pentoclo
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 |
|---|---|---|
| Pentoxifylline-Tocopherol-ClodronateAlso: Pentoclothe aim of this retrospective study is to analyze from patient records the impact of the PENTOCLO protocol on maxillofacial osteoradionecrosis at Brest Hospital University, France. | Drug | – |
Primary outcome
Clinical evolution of the osteoradionecrosis lesion after introducing PENTOCLO protocol
Time frame: 2 years
Retrospective study based on recovering patient data from medical records
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Osteoradionecrosis of Jaw, run by University Hospital, Brest at 1 site in France.
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 1 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: finished, as of the sponsor's last update on 1 Nov 2019. 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 France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical evolution of the osteoradionecrosis lesion after introducing PENTOCLO protocol (time frame: 2 years). 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 1 Nov 2019.