UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039045 |
|---|---|
| Receipt number | R000044524 |
| Scientific Title | Phase 1 multi-center study of safety and feasibility of chemoradiotherapy using oxydol for cervical cancer |
| Date of disclosure of the study information | 2020/01/06 |
| Last modified on | 2020/01/03 00:32:52 |
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Basic information
Public title
Phase 1 multi-center study of safety and feasibility of chemoradiotherapy using oxydol for cervical cancer
Acronym
Pilot study of chemoradiotherapy using oxydol for cervical cancer
Scientific Title
Phase 1 multi-center study of safety and feasibility of chemoradiotherapy using oxydol for cervical cancer
Scientific Title:Acronym
Pilot study of chemoradiotherapy using oxydol for cervical cancer
Region
| Japan |
Condition
Condition
cervical cancer
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Analyze the feasibility and safety using hydrogen peroxide as a substitute of brachytherapy for cervical cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase I
Assessment
Primary outcomes
1 month after treatment completion, 1 year, 2 years overall survival, disease-free survival and progression-free survival
Key secondary outcomes
Type, severity, and ratio of adverse events that occurred up to the date of follow-up observation
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Hydrogen peroxide was to be used twice a week (Monday and Thursday/Tuesday and Friday) in combination with CCRT. We inserted 3% hydrogen peroxide solution-soaked gauze into vagina firmly contact to the lesion immediately before RT and removed it right after RT.This procedure was done by the attending gynecologist.
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
| 90 | years-old | >= |
Gender
Female
Key inclusion criteria
we recruited patients who have cervical caner needed radio-sensitization treatment because of unfeasibility to the standard therapy. Our selection criteria are as follow: cervical cancer patient; radical CCRT purpose; impossible or refusal of brachytherapy; 20 years or older ; without hematogenous metastasis ; having a ECOG Performance Status up to 2, and no pathological limitation, without prior treatment.
Key exclusion criteria
less than 20 years old
having distant metastasis
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | yuko |
| Middle name | anne |
| Last name | saito |
Organization
Juntendo University Urayasu Hospital
Division name
Department of Radiation Oncology
Zip code
279-0021
Address
2-1-1 Tomioka, Urayasu-shi, Chiba
TEL
047-353-3111
anyusaike@yahoo.co.jp
Public contact
Name of contact person
| 1st name | yuko |
| Middle name | anne |
| Last name | saito |
Organization
Juntendo University Urayasu Hospital
Division name
Department of Radiation Oncology
Zip code
279-0021
Address
2-1-1 Tomioka, Urayasu-shi, Chiba
TEL
047-353-3111
Homepage URL
anyusaike@yahoo.co.jp
Sponsor or person
Institute
Juntendo University Urayasu Hospital
Institute
Department
Personal name
Funding Source
Organization
Juntendo University Urayasu Hospital
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
Juntendo University Urayasu Hospital
Address
2-1-1 Tomioka, Urayasu-shi, Chiba
Tel
047-353-3111
anyusaike@yahoo.co.jp
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
| 2020 | Year | 01 | Month | 06 | 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
20
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
| 2014 | Year | 01 | Month | 05 | Day |
Date of IRB
| 2013 | Year | 08 | Month | 01 | Day |
Anticipated trial start date
| 2014 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 08 | Month | 31 | Day |
Date trial data considered complete
| 2019 | Year | 08 | Month | 31 | Day |
Date analysis concluded
| 2020 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2020 | Year | 01 | Month | 03 | Day |
Last modified on
| 2020 | Year | 01 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044524
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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