UMIN-CTR Clinical Trial

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

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000004897
Receipt No. R000005807
Scientific Title Phase l/ll study of adjuvant chemotherapy (TC therapy) after concurrent chemoradiation in cervical cancer with lymphadenopathy
Date of disclosure of the study information 2011/01/19
Last modified on 2011/01/19

* 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 l/ll study of adjuvant chemotherapy (TC therapy) after concurrent chemoradiation in cervical cancer with lymphadenopathy
Acronym Phase l/ll study of TC therapy after CCRT in cervical cancer
Scientific Title Phase l/ll study of adjuvant chemotherapy (TC therapy) after concurrent chemoradiation in cervical cancer with lymphadenopathy
Scientific Title:Acronym Phase l/ll study of TC therapy after CCRT in cervical cancer
Region
Japan

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

Objectives
Narrative objectives1 The aim of this study was to evaluate the efficacy and toxicities of CCRT followed by adjuvant chemotherapy with paclitaxel and carboplatin for patients with lymphadenopathy for cervical cancer
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase I,II

Assessment
Primary outcomes PFS, tixicity
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 TC therapy after CCRT
Interventions/Control_2 No adjuvant chemotherapy after CCRT
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
75 years-old >=
Gender Female
Key inclusion criteria Patients with FIGO Stage lB2 - lVA of cervical carcinoma and who had lymphadenopathy (N=1) were eligible. No previous chemotherapy or radiotherapy was allowed. Other eligibility criteria include age under 75 years old, Easttern Cooperation Oncology Group (ECOG) performance status score 0-1, blood cell counts, serum level of bloody urea nitrogen, creatinine, bilirubin within normal ranges, and normal cardiovascular function. The criterion for malignancy on positron emission tomography computed tomography (PET/CT) and magnetic resonance imaging (MRI) was a pelvis or para-aortic lymph node with short-axis dimension > 1cm or SUV > 3.
Key exclusion criteria severe complications
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroyuki Furumoto
Organization The University of Tokushima Graduate School
Division name Department of Obstetrics and Gynecology, Institute of Health Biosciences
Zip code
Address 3-18-15 Kuramoto-cho, Tokushima, 770-8503 Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization The University of Tokushima Graduate School
Division name department of Obstetrics and Gynecology, Institute of Health Biosciences
Zip code
Address
TEL
Homepage URL
Email akiko06090111@yahoo.co.jp

Sponsor
Institute The University of Tokushima Graduate School
Institute
Department

Funding Source
Organization The University of Tokushima Graduate School
Organization
Division
Category of Funding Organization
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
2011 Year 01 Month 19 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 Preinitiation
Date of protocol fixation
2011 Year 01 Month 24 Day
Date of IRB
Anticipated trial start date
2011 Year 02 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

Management information
Registered date
2011 Year 01 Month 19 Day
Last modified on
2011 Year 01 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005807

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.