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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004272
Receipt No. R000005124
Scientific Title The evaluation of supportive care for stomatitis in patients with recurrent/ relapsed Müllerian carcinoma received chemotherapy of pegylated liposomal doxorubicin
Date of disclosure of the study information 2010/09/28
Last modified on 2015/09/30

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Basic information
Public title The evaluation of supportive care for stomatitis in patients with recurrent/ relapsed Müllerian carcinoma received chemotherapy of pegylated liposomal doxorubicin
Acronym Doxil trial for stomatitis
Scientific Title The evaluation of supportive care for stomatitis in patients with recurrent/ relapsed Müllerian carcinoma received chemotherapy of pegylated liposomal doxorubicin
Scientific Title:Acronym Doxil trial for stomatitis
Region
Japan

Condition
Condition Recurrent/ Relapsed Müllerian carcinoma
Classification by specialty
Obsterics and gynecology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the significance of supportive care for and stomatitis in patients with recurrent/ relapsed Müllerian carcinoma received chemotherapy of pegylated liposomal doxorubicin (50mg/m2 or 40mg/m2q4weeks)
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes The incidence of more than grade2 stomatitis
Key secondary outcomes The proportion of patients requiring dose reduction, dose delay, and the discontinuation due to stomatitis
The incidence of adverse event except for stomatitis
The proportion of patients requiring dose reduction, dose delay, and the discontinuation due to adverse event except for stomatitis

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 Behavior,custom Maneuver
Other
Interventions/Control_1 a) Dentistry consultation until DOXIL treatment two weeks before
b) Self-brushing and moisture retention in the oral cavity
c) Gargling with aznol saline gargle
d) Internal use of Rebamipide(300mg/day) and a Vitamin B6/B12 tablet
e) Education and guidance
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
20 years-old <=
Age-upper limit

Not applicable
Gender Female
Key inclusion criteria 1. Patients with recurrent/ relapsed M&uuml;llerian carcinoma received chemotherapy of pegylated liposomal doxorubicin (50mg/m2 or 40mg/m2). The period from final chemotherapy should not be over 12 months. All patients should not have measurable lesions with the RECIST criteria.
2. Performance status: 0-2
3. Age: More than 20 years old
4. Patients without severe dysfunction of major organs
5. Patients can be alive over 4 months after treatment
6. Patients must have signed informed consent
Key exclusion criteria 1. Patients having fever over 38.0
2. Patients with infection
3. Patients with severe complications
4. Patients with double cancer
5. Patients with massive pleural effusion, ascites and pericardial fluid need to continuous drainage
6. Patients received chemotherapy including anthracycline
7. Patients with brain metastasis
8. Patient with previous hypersensitivity reaction to doxorubicin HCL or component of pegylated liposomal doxorubicin
9. Gravida, patients with lactation and with intent to pregnancy
10. Patients judged as the exclusive case by the investigator
Target sample size 42

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Muneaki Shimada
Organization Tottori University School of medicine
Division name Department of obstetrics and gynecology
Zip code
Address Nishimachi 36-1, Yonago, Japan
TEL 0859-38-6647
Email mshima12@med.tottori-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Muneaki Shimada
Organization Faculty of Medicine, Tottori University
Division name Division of Reproductive-Perinatal medicine and Gynecologic Oncology
Zip code
Address Nishimachi 36-1, Yonago, Tottori, Japan
TEL 0859-38-6647
Homepage URL
Email mshima12@med.tottori-u.ac.jp

Sponsor
Institute Japan Doxil study group
Institute
Department

Funding Source
Organization Gynecological Tumor Support Organization
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

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 20施設,専門病院・医院(宮城県、岩手県、青森県、山形県、栃木県、茨城県、埼玉県、東京都、愛知県、三重県、大阪府、兵庫県、広島県、鳥取県、愛媛県、鹿児島県)

Other administrative information
Date of disclosure of the study information
2010 Year 09 Month 28 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
2010 Year 06 Month 04 Day
Date of IRB
Anticipated trial start date
2010 Year 09 Month 01 Day
Last follow-up date
2011 Year 09 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2010 Year 09 Month 27 Day
Last modified on
2015 Year 09 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005124

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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