UMIN-CTR Clinical Trial

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.