Osteoradionecrosis and PENTOCLO Protocol: Retrospective Study (OPEN)

October 31, 2019 updated by: University Hospital, Brest

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

96

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Brest, France, 29609
        • CHRU de Brest

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Tumoral recidivism
  • Precocious stop of pentoclo

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical evolution of the osteoradionecrosis lesion after introducing PENTOCLO protocol
Time Frame: 2 years
Retrospective study based on recovering patient data from medical records
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Brest

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 2, 2017

Primary Completion (Actual)

April 1, 2019

Study Completion (Actual)

April 1, 2019

Study Registration Dates

First Submitted

May 14, 2019

First Submitted That Met QC Criteria

September 19, 2019

First Posted (Actual)

September 20, 2019

Study Record Updates

Last Update Posted (Actual)

November 1, 2019

Last Update Submitted That Met QC Criteria

October 31, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OPEN (29BRC17.0115)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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