OPEN: Osteoradionecrosis and PENTOCLO Protocol: Retrospective Study

• Sponsor: University Hospital, Brest (Other)
• Overall Status: Completed
• CT.gov ID: NCT04097847
• Collaborator: (none)
• Enrollment: 96
• Location: 1
• Actual Duration (Months): 21.9
• Patients Per Site Per Month: 4.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Osteoradionecrosis of Jaw	Drug: Pentoxifylline-Tocopherol-Clodronate

Study Design

• Study Type: Observational
• Actual Enrollment: 96 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Osteoradionecrosis and PENTOCLO Protocol: Retrospective Study.
• Actual Study Start Date: Jun 2, 2017
• Actual Primary Completion Date: Apr 1, 2019
• Actual Study Completion Date: Apr 1, 2019

Outcome Measures

Primary Outcome Measures

1. Clinical evolution of the osteoradionecrosis lesion after introducing PENTOCLO protocol [2 years]

   Retrospective study based on recovering patient data from medical records

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHRU de Brest	Brest		France	29609

Sponsors and Collaborators

• University Hospital, Brest

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University Hospital, Brest
• ClinicalTrials.gov Identifier: NCT04097847
• Other Study ID Numbers: OPEN (29BRC17.0115)
• First Posted: Sep 20, 2019
• Last Update Posted: Nov 1, 2019
• Last Verified: Feb 1, 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Osteoradionecrosis; Clodronic Acid; Tocopherols; Vitamin E; Tocotrienols; alpha-Tocopherol; Pentoxifylline

Study Results

No Results Posted as of Nov 1, 2019