UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The efficacy and safety of concurrent chemoradiotherapy for squamous cell carcinoma of the vulva. Phase II Study
Title of the study (Brief title)	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	Hideki Mizunuma
Organization	Hirosaki University School of Medicine
Division name	Department of Obstetrics & Gynecology
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	Masayuki Futagami
Organization	TGCU(Tohoku Gynecological Cancer Unit)
Division name	Department of Obstetrics & Gynecology
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)

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

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2013 Year 12 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000015692