Unique ID issued by UMIN | UMIN000013439 |
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Receipt number | 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 09:05:40 |
The efficacy and safety of concurrent chemoradiotherapy for squamous cell carcinoma of the vulva. Phase II Study
ESCCSV TRIAL
The efficacy and safety of concurrent chemoradiotherapy for squamous cell carcinoma of the vulva. Phase II Study
ESCCSV TRIAL
Japan |
Vulva cancer
Obstetrics and Gynecology |
Malignancy
NO
To evaluate the efficacy and the safety of concurrent chemoradiotherapy for squamous cell carcinoma of the vulva.
Safety,Efficacy
Confirmatory
Explanatory
Phase II
Local control rate
Progression free survival, Overall survival rate
Interventional
Single arm
Non-randomized
Open -no one is blinded
Historical
1
Treatment
Medicine | Maneuver |
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.
20 | years-old | <= |
80 | years-old | >= |
Female
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
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
40
1st name | |
Middle name | |
Last name | Hideki Mizunuma |
Hirosaki University School of Medicine
Department of Obstetrics & Gynecology
036-8562, 5 Zaifu-cho, Hirosaki, Japan
0172-39-5107
mizunuma@cc.hirosaki-u.ac.jp
1st name | |
Middle name | |
Last name | Masayuki Futagami |
TGCU(Tohoku Gynecological Cancer Unit)
Department of Obstetrics & Gynecology
036-8562, 5 Zaifu-cho, Hirosaki, Japan
0172-39-5107
futagami@cc.hirosaki-u.ac.jp
TGCU(Tohoku Gynecological Cancer Unit)
TGCU(Tohoku Gynecological Cancer Unit)
Other
NO
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)
2014 | Year | 03 | Month | 18 | Day |
Unpublished
Open public recruiting
2013 | Year | 12 | Month | 01 | Day |
2014 | Year | 03 | Month | 18 | Day |
2014 | Year | 03 | Month | 17 | Day |
2018 | Year | 03 | Month | 20 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015692
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