Unique ID issued by UMIN | UMIN000020075 |
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Receipt number | R000023167 |
Scientific Title | Phase II Randomized Radiation Dose Study of Concurrent Chemoradiotherapy With S-1 Plus Nedaplatin for Esophageal Cancer |
Date of disclosure of the study information | 2015/12/17 |
Last modified on | 2018/12/12 09:04:18 |
Phase II Randomized Radiation Dose Study of Concurrent Chemoradiotherapy With S-1 Plus Nedaplatin for Esophageal Cancer
Radiation Dose Study of CCRT with S-1 / NDP for Esophageal Cancer
Phase II Randomized Radiation Dose Study of Concurrent Chemoradiotherapy With S-1 Plus Nedaplatin for Esophageal Cancer
Radiation Dose Study of CCRT with S-1 / NDP for Esophageal Cancer
Japan |
esophageal cancer
Gastroenterology | Gastrointestinal surgery | Radiology |
Malignancy
NO
To compare the local control rates of 50.4Gy and 60Gy in CCRT for esophageal cancer.
Safety,Efficacy
Exploratory
Pragmatic
Phase II
2-year local control rate within PTV.
Overall survival, progression-free survival, frequency and degree of adverse events, and Quality of life in full observation period.
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Dose comparison
YES
YES
Institution is considered as a block.
YES
Central registration
2
Treatment
Medicine | Device,equipment |
S-1 80mg/ m2/day (day1-14, 29-42, po)
NDP 80mg/m2/day (day1, 29, iv)
Radiation therapy 1.8Gy/day, 28fractions (day1-38), 5 fractions/week, total 50.4Gy
S-1 80mg/ m2/day (day1-14, 29-42, po)
NDP 80mg/m2/day (day1, 29, iv)
Radiation therapy 2Gy/day, 30fractions (day1-40), 5 fractions/week, total 60Gy
20 | years-old | <= |
75 | years-old | >= |
Male and Female
a) Pathologically proven squamous cell carcinoma or adenocarcinoma of the esophagus
b) tumors can be included within a single irradiation field
c) age >= 20, <= 75
d) Karnofsky performance status : >= 70%
e) Patients with sufficient organ function
-WBC >= 3,000 /mm3
-Platelet >= 100,000 /mm3
-Hb >= 10 g/dL
-GOT, GTP <= 2.0 times upper limit of normal(ULN)
-T.Bil <= 1.5 mg/dL
-Creatinine <= 1.2 mg/dL
-Creatinine clearance or eGFR <= 50 ml/min
-PaO2 >= 70 mmHg
-ECG: no severe abnormalities
f) No prior chemotherapy or no prior irradiation
g) Written informed concent
a) with active gastrointestinal hemorrhage
b) with clinically important infection
c) with severe complicatons (heart failure, renal failure, liver failure, uncontrollable diabetes, etc.)
d) with another active malignant tumors
e) pregnant and/or lactating women
f) judged not to understand the trial explanation
g) judged to be unfit to participate in this study by investigater
100
1st name | |
Middle name | |
Last name | YAMASHITA Hideomi |
The University of Tokyo Hospital
The department of Radiology
7-3-1, Hongo, Bunkyo-ku, Tokyo
+81-3-5800-8667
yamachan07291973@yahoo.co.jp
1st name | |
Middle name | |
Last name | KIRITOSHI Tomoki |
The University of Tokyo Hospital
The department of Radiology
7-3-1, Hongo, Bunkyo-ku, Tokyo
+81-3-5800-8667
http://www.u-tokyo-rad.jp/2015/10/30164804.html
kiritoshit-rad@h.u-tokyo.ac.jp
The University of Tokyo Hospital
None
Self funding
NO
東京大学医学部附属病院
2015 | Year | 12 | Month | 17 | Day |
Unpublished
Enrolling by invitation
2015 | Year | 11 | Month | 19 | Day |
2015 | Year | 12 | Month | 14 | Day |
2021 | Year | 03 | Month | 31 | Day |
2015 | Year | 12 | Month | 04 | Day |
2018 | Year | 12 | Month | 12 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023167
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