UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000039045
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Obsterics 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
Email 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
Email anyusaike@yahoo.co.jp

Sponsor
Institute Juntendo University Urayasu Hospital
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044524

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.