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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000040035
Receipt No. R000045642
Scientific Title Single-institution prospective observational study using intensity-modulated radiation therapy for cervical cancer
Date of disclosure of the study information 2020/04/09
Last modified on 2020/04/13

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Basic information
Public title Single-institution prospective observational study using intensity-modulated radiation therapy for cervical cancer
Acronym Single-institution prospective observational study using intensity-modulated radiation therapy for cervical cancer
Scientific Title Single-institution prospective observational study using intensity-modulated radiation therapy for cervical cancer
Scientific Title:Acronym Single-institution prospective observational study using intensity-modulated radiation therapy for cervical cancer
Region
Japan

Condition
Condition Cervical cancer
Classification by specialty
Obsterics and gynecology Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy and safety of definitive treatment using intensity-modulated radiation therapy(IMRT) for cervical cancer prospectively
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes IMRT completion rate
Key secondary outcomes Efficacy: overall survival, progression-free survival, locoregional control interval
Safety: incidence of adverse event

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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) Scheduled definitive treatment using IMRT for cervical cancer
2) 20 years old or older
3) Informed consent has been obtained
Key exclusion criteria 1) Informed consent has not been obtained
2) Inappropriate patient for this study
Target sample size 20

Research contact person
Name of lead principal investigator
1st name Masahide
Middle name
Last name Anada
Organization Kagawa University Hospital
Division name Department of Radiation Oncology
Zip code 761-0793
Address 1750-1 Ikenobe, Miki-cho, Kita-gun, Kagawa
TEL 087-898-5111
Email anada-m@med.kagawa-u.ac.jp

Public contact
Name of contact person
1st name Masahide
Middle name
Last name Anada
Organization Kagawa University Hospital
Division name Department of Radiation Oncology
Zip code 761-0793
Address 1750-1 Ikenobe, Miki-cho, Kita-gun, Kagawa
TEL 087-898-5111
Homepage URL
Email anada-m@med.kagawa-u.ac.jp

Sponsor
Institute Kagawa University Hospital
Institute
Department

Funding Source
Organization No research expenses required
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Ethics committee, Kagawa University Faculty of Medicine
Address 1750-1 Ikenobe, Miki-cho, Kita-gun, Kagawa
Tel 087-898-5111
Email kenkyushien@med.kagawa-u.ac.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 香川大学医学部附属病院

Other administrative information
Date of disclosure of the study information
2020 Year 04 Month 09 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 Enrolling by invitation
Date of protocol fixation
2020 Year 03 Month 05 Day
Date of IRB
2020 Year 03 Month 19 Day
Anticipated trial start date
2020 Year 04 Month 09 Day
Last follow-up date
2026 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Efficacy and safety

Management information
Registered date
2020 Year 04 Month 02 Day
Last modified on
2020 Year 04 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045642

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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