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CompletedNCT04097847OPENUpdated Nov 1, 2019

Osteoradionecrosis and PENTOCLO Protocol: Retrospective Study

An observational study in Osteoradionecrosis of Jaw, sponsored by University Hospital, Brest. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-11-01.

Sponsored by University Hospital, Brest · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
96
Ages
18 Years and older
Sex
All
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Study 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. The understanding of new pathological mechanisms opens the way to new therapeutic perspectives.

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Conditions studied

  • Osteoradionecrosis of Jaw

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03

In context

Osteoradionecrosis

24 studies on the registry are indexed under Osteoradionecrosis; 8 are open to participants now.

This study's enrollment of 96 is below the median of 140 across 10 observational studies indexed under Osteoradionecrosis.

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Lead sponsor

University Hospital, Brest is the lead sponsor of 601 studies on the registry; 136 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patient over 18 being or having been treated by pentoclo combination for an osteoradionecrosis of the jaw

Exclusion criteria

Exclusion Criteria:

  • Tumoral recidivism
  • Precocious stop of pentoclo
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Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
96 participants (actual)
Patient registry
No

Interventions

  • DrugPentoxifylline-Tocopherol-Clodronate

    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.

    Also known as: Pentoclo

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What researchers measure

Primary outcomes

  1. Clinical evolution of the osteoradionecrosis lesion after introducing PENTOCLO protocol

    Retrospective study based on recovering patient data from medical records

    Time frame: 2 years

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Study locations

1 site
  • CHRU de Brest
    Brest, 29609, France
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 1, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04097847
Responsible party
Sponsor
First posted
Sep 20, 2019
Start date
Jun 2, 2017
Primary completion
Apr 1, 2019
Completion
Apr 1, 2019
Last update
Nov 1, 2019

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.

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Discussion

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