UMIN-CTR Clinical Trial

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

Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000025274
Receipt No. R000029072
Scientific Title A retrospective study of late effect and prognosis of concurrent chemoradiotherapy (CCRT) for locally advanced cervical cancer.
Date of disclosure of the study information 2016/12/14
Last modified on 2016/12/14

* 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 A retrospective study of late effect and prognosis of concurrent chemoradiotherapy (CCRT) for locally advanced cervical cancer.
Acronym A retrospective study of late effect and prognosis of concurrent chemoradiotherapy (CCRT)
Scientific Title A retrospective study of late effect and prognosis of concurrent chemoradiotherapy (CCRT) for locally advanced cervical cancer.
Scientific Title:Acronym A retrospective study of late effect and prognosis of concurrent chemoradiotherapy (CCRT)
Region
Japan

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

Objectives
Narrative objectives1 To clear the late effect of CCRT for locally advanced cervical cancer
Basic objectives2 Others
Basic objectives -Others To clear the prognosis of CCRT for locally advanced cervical cancer
Trial characteristics_1 Others
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes The frequency of small intestinal obstruction, rectal hemmorrhage, and bladder hemmorrhage
Key secondary outcomes

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

Not applicable
Age-upper limit

Not applicable
Gender Female
Key inclusion criteria Cervical cancer Stage IB2, IIB, IIIB, and IVA and treated by CCRT.
Treatment start is from January 2001 to December 2010.
Key exclusion criteria CCRT for post operative treatment
Target sample size 750

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Akira Kurosaki
Organization Saitama Medical University International Medical Center
Division name Department of Gynecologic Oncology
Zip code
Address Yamane 1397-1, Hidaka city, Saitama, Japan
TEL 042-984-4111
Email akirak@saitama-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Akira Kurosaki
Organization GOTIC (Gynecologic Oncology Trial and Investigation Consortium of North Kanto)
Division name Department of Gynecologic Oncology
Zip code
Address Morohongo 5, Moroyama town, Saitama, Japan
TEL 049-292-9043
Homepage URL
Email akirak@saitama-med.ac.jp

Sponsor
Institute GOTIC (Gynecologic Oncology Trial and Investigation Consortium of North Kanto)
Institute
Department

Funding Source
Organization GOTIC (Gynecologic Oncology Trial and Investigation Consortium of North Kanto)
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
Address
Tel
Email

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
2016 Year 12 Month 14 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
2014 Year 11 Month 11 Day
Date of IRB
Anticipated trial start date
2015 Year 01 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information multicenter retrospective study

Management information
Registered date
2016 Year 12 Month 14 Day
Last modified on
2016 Year 12 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029072

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.