UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000076 |
|---|---|
| Receipt number | 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 15:54:12 |
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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
| Obstetrics 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
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
unotakas@faculty.chiba-u.jp
Sponsor or person
Institute
Study Group of Postoperative radiotherapy for cervical cancer.
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000125
