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Recruitment status
Unique ID issued by UMIN C000000076
Receipt No. R000000125
Scientific Title A prospective open-randomized controlled trial comparing postoperative chemoradiotherapy versus chemotherapy for cervical cancer patients with lymph node metastases.
Date of disclosure of the study information 2010/04/01
Last modified on 2005/08/24

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Basic information
Public title A prospective open-randomized controlled trial comparing postoperative chemoradiotherapy versus chemotherapy for cervical cancer patients with lymph node metastases.
Acronym Postoperative radiotherapy for cervical cancer.
Scientific Title A prospective open-randomized controlled trial comparing postoperative chemoradiotherapy versus chemotherapy for cervical cancer patients with lymph node metastases.
Scientific Title:Acronym Postoperative radiotherapy for cervical cancer.
Region
Japan

Condition
Condition Patients who had radical hysterectomy for stage IB-IIB cervical cancer, and were certified to have lymph node mestastases histologocally after radical surgery. Patients with only squamous cell carcinoma were eligible.
Classification by specialty
Obsterics and gynecology Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to clarify the efficiency of concurrent chemoradiotherapy (group A) and chemotherapy (Group B) for paitents with lymph node metastases from cervical cancer. Patients are randomized to group A or B after radical surgery.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase II,III

Assessment
Primary outcomes Recurrent rata including distant metastases.
Key secondary outcomes Late adverse effect
Survival

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation NO
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking NO
Concealment Pseudo-randomization

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Concurrent chemoradiotherapy (Group A)
Whole pelvic irradiation (50 Gy) and
CDDP 70mg/m2, each 4 week, 3 times.
Interventions/Control_2 Chemotherapy (Group B)
CDDP 70mg/m2, each 4 week, 3 times.
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 Male and Female
Key inclusion criteria 1. squamous cell carcinoma of the cervix and clinical stage IB-IIB.
2. radical hysterectomy was performed.
3. with histologically certified lymph node metastases.
4. no abnormal findings in laboratory tests.
5. PS is between 0-2.
6. Age is between 20-75.
7. No chemotherapy for other cancer (except cervical cancer) within recent 3 months.
Key exclusion criteria 1. Past history of pelvic surgery (except appendectomy).
2. past history of pelvic irradiation.
3. Positive surgical margin, or positive paraaortic lymph nodes.
4. Estimaated survival is less than 6 months.
5. Renal dysfunction.
6. Acitve infection (Tuberculosis or mycosis) in the pelvis.
7. Active double cancer.
8. Otehr reasons that is not eligible to this trial.
Target sample size 170

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hisao Ito, M.D.
Organization Chiba University, Graduate School of Medicine,
Division name Department of Radiology
Zip code
Address 1-8-1 Inohana, Chuoku, Chiba City, 260-8670, Japan
TEL 043-226-2099
Email

Public contact
Name of contact person
1st name
Middle name
Last name Takahsi Uno, M.D.
Organization Chiba University, Graduate School of Medicine,
Division name Department of Radiology
Zip code
Address 1-8-1 Inohana, Chuoku, Chiba City, 260-8670, Japan
TEL 043-226-2100
Homepage URL
Email unotakas@faculty.chiba-u.jp

Sponsor
Institute Study Group of Postoperative radiotherapy for cervical cancer.
Institute
Department

Funding Source
Organization Grant of Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor none
Name of secondary funder(s) none

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
2010 Year 04 Month 01 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
Date of protocol fixation
2005 Year 01 Month 10 Day
Date of IRB
Anticipated trial start date
2005 Year 02 Month 01 Day
Last follow-up date
2010 Year 04 Month 01 Day
Date of closure to data entry
2011 Year 03 Month 01 Day
Date trial data considered complete
2012 Year 04 Month 01 Day
Date analysis concluded
2012 Year 07 Month 01 Day

Other
Other related information

Management information
Registered date
2005 Year 08 Month 24 Day
Last modified on
2005 Year 08 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000125

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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