UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004272 |
|---|---|
| Receipt number | 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 10:20:32 |
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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
| Obstetrics 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 Müllerian 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
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
mshima12@med.tottori-u.ac.jp
Sponsor or person
Institute
Japan Doxil study group
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005124
