Osteoradionecrosis and PENTOCLO Protocol: Retrospective Study
OPEN
1 other identifier
observational
96
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jun 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 2, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2019
CompletedFirst Submitted
Initial submission to the registry
May 14, 2019
CompletedFirst Posted
Study publicly available on registry
September 20, 2019
CompletedNovember 1, 2019
February 1, 2019
1.8 years
May 14, 2019
October 31, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Clinical evolution of the osteoradionecrosis lesion after introducing PENTOCLO protocol
Retrospective study based on recovering patient data from medical records
2 years
Interventions
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.
Eligibility Criteria
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
You may qualify if:
- Patient over 18 being or having been treated by pentoclo combination for an osteoradionecrosis of the jaw
You may not qualify if:
- Tumoral recidivism
- Precocious stop of pentoclo
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHRU de Brest
Brest, 29609, France
MeSH Terms
Interventions
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 14, 2019
First Posted
September 20, 2019
Study Start
June 2, 2017
Primary Completion
April 1, 2019
Study Completion
April 1, 2019
Last Updated
November 1, 2019
Record last verified: 2019-02