UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000019780
Receipt number R000022847
Scientific Title Chemotherapy for osteoradionecrosis of mandible using a pentoxifylline-tocopherol-clodronate combination (PENTOCLO).
Date of disclosure of the study information 2015/11/13
Last modified on 2021/09/15 18:09:23

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Basic information

Public title

Chemotherapy for osteoradionecrosis of mandible using a pentoxifylline-tocopherol-clodronate combination (PENTOCLO).

Acronym

Chemotherapy for osteoradionecrosis using PENTOCLO

Scientific Title

Chemotherapy for osteoradionecrosis of mandible using a pentoxifylline-tocopherol-clodronate combination (PENTOCLO).

Scientific Title:Acronym

Chemotherapy for osteoradionecrosis using PENTOCLO

Region

Japan


Condition

Condition

Osteoradionecrosis of the mandible

Classification by specialty

Oral surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To heal osteoradionecrosis of the mandible which usually requires segmental bone resection using a pentoxifylline-tocopherol-clodronate combination.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Sequestration with oral mucosal and cutaneous healing

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Historical

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Pentoxifillyne 800mg/day 5 days in a week 1 year
Clodoronate 1600mg/day 7 days in a week 1 year
Tocopherol 1g/day 7days in a week 1 year

Interventions/Control_2


Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

0 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Osteoradionecrosis with oral mucosal and/or skin defect with or without pus discharging.

Key exclusion criteria

A patient with gastrointestinal disease

Target sample size

20


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hirota, Makoto

Organization

Yokohama City University

Division name

Oral and Maxillofacial Surgery

Zip code


Address

3-9 Fukuura, Kanazawaku, Yokohama City

TEL

045-787-2800

Email

mhirota@yokohama-cu.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Hirota, Makoto

Organization

Yokohama City University

Division name

Oral and Maxillofacial Surgery

Zip code


Address

3-9 Fukuura, Kanazawaku, Yokohama City

TEL

045-787-2800

Homepage URL


Email

mhirota@yokohama-cu.ac.jp


Sponsor or person

Institute

Yokohama City University

Institute

Department

Personal name



Funding Source

Organization

Yokohama City University

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2015 Year 11 Month 13 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2015 Year 04 Month 21 Day

Date of IRB

2015 Year 10 Month 01 Day

Anticipated trial start date

2015 Year 10 Month 01 Day

Last follow-up date

2019 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2015 Year 11 Month 13 Day

Last modified on

2021 Year 09 Month 15 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022847


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name