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Name
UMIN ID

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000013439
Receipt No. R000015692
Scientific Title The efficacy and safety of concurrent chemoradiotherapy for squamous cell carcinoma of the vulva. Phase II Study
Date of disclosure of the study information 2014/03/18
Last modified on 2018/03/20

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Basic information
Public title The efficacy and safety of concurrent chemoradiotherapy for squamous cell carcinoma of the vulva. Phase II Study
Acronym ESCCSV TRIAL
Scientific Title The efficacy and safety of concurrent chemoradiotherapy for squamous cell carcinoma of the vulva. Phase II Study
Scientific Title:Acronym ESCCSV TRIAL
Region
Japan

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

Objectives
Narrative objectives1 To evaluate the efficacy and the safety of concurrent chemoradiotherapy for squamous cell carcinoma of the vulva.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Phase II

Assessment
Primary outcomes Local control rate
Key secondary outcomes Progression free survival, Overall survival rate

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine Maneuver
Interventions/Control_1 Radiotherapy; Irradiation amount to the vulva is less than a total dose of 65Gy consisting of extra beam radiation of a fraction dose of 1.2-2 Gy per day in 5 times a week. In the case with definitely pelvic and inguinal lymph node metastasis, whole pelvis irradiation of a total 50 Gy, and inguinal lymph node irradiation of a total 65Gy are added.
Chemotherapy: Nedaplatin is administered weekly at a dose of 30mg/m2 for 6 weeks.
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
80 years-old >=
Gender Female
Key inclusion criteria 1. Squamous cell carcinoma of the vulva
2. The tumor had to be grossly measurable
3. Initial treatment case
4. Age between 20 and 80 years old
5. ECOG Performance status 0-1
6. Normal organ function
(WBC>=3000/mm3, Neutrophil >=1500/mm3, Platelet 100,000/mm3, GOT(AST) and GPT(ALT) <=twice upper within limit, Total Bilirubin<1.5 mg/dL, Cre <= within upper limit, Ccr >= 60ml/min)
7. Written informed consent
Key exclusion criteria 1. History of chemotherapy or radiotherapy
2. Active double cancer
3. Active infection
4. Severe complicating illness ( bronchial asthma, pneumonia, ischemic heart disease, diabetes mellitus, arrhythmia)
5. Massive ascites or pleural fluid
6. History of severe allergic reaction
7. pregnant, lactating women and women who expects pregnant
8. Difficult case to keep the regulations and observations
9. Other reason that primary doctor think ineligible
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hideki Mizunuma
Organization Hirosaki University School of Medicine
Division name Department of Obstetrics & Gynecology
Zip code
Address 036-8562, 5 Zaifu-cho, Hirosaki, Japan
TEL 0172-39-5107
Email mizunuma@cc.hirosaki-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masayuki Futagami
Organization TGCU(Tohoku Gynecological Cancer Unit)
Division name Department of Obstetrics & Gynecology
Zip code
Address 036-8562, 5 Zaifu-cho, Hirosaki, Japan
TEL 0172-39-5107
Homepage URL
Email futagami@cc.hirosaki-u.ac.jp

Sponsor
Institute TGCU(Tohoku Gynecological Cancer Unit)
Institute
Department

Funding Source
Organization TGCU(Tohoku Gynecological Cancer Unit)
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 弘前大学医学部付属病院(青森県)、岩手医科大学附属病院(岩手県)、秋田大学医学部附属病院(秋田県)、東北大学病院(宮城県)、山形大学医学部附属病院(山形県)、宮城県立がんセンター(宮城県)

Other administrative information
Date of disclosure of the study information
2014 Year 03 Month 18 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 Open public recruiting
Date of protocol fixation
2013 Year 12 Month 01 Day
Date of IRB
Anticipated trial start date
2014 Year 03 Month 18 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
2014 Year 03 Month 17 Day
Last modified on
2018 Year 03 Month 20 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015692

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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