Unique ID issued by UMIN | UMIN000009880 |
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Receipt number | R000011462 |
Scientific Title | A phase II study of intensity modulated radiation therapy (IMRT) with chemotherapy for cervical esophageal cancer (JROSG12-1) |
Date of disclosure of the study information | 2013/01/28 |
Last modified on | 2018/08/08 08:25:55 |
A phase II study of intensity modulated radiation therapy (IMRT) with chemotherapy for cervical esophageal cancer (JROSG12-1)
IMRT for cervical esophageal cancer (JROSG12-1)
A phase II study of intensity modulated radiation therapy (IMRT) with chemotherapy for cervical esophageal cancer (JROSG12-1)
IMRT for cervical esophageal cancer (JROSG12-1)
Japan |
cervical esophageal cancer
Gastroenterology | Gastrointestinal surgery | Oto-rhino-laryngology |
Radiology | Adult |
Malignancy
NO
To evaluate the efficacy and the safety of chemoradiotherapy with Intensity Modulated Radiation Therapy (IMRT) in patients with cervical esophageal cancer (clinical stage II-III, or IV with supraclavicular LN metastasis, UICC 7th edition)
Safety,Efficacy
Confirmatory
Phase II
3 year overall survival
3 year progeression-free survival, 3y esophagus preservation rate, 3y larynx preservation rate, early and late adverse event rates
Interventional
Single arm
Non-randomized
Open -no one is blinded
Historical
1
Treatment
Maneuver |
Concurrent chemoradiotherapy with SIB-IMRT (60Gy (prophylactin LN region: 48Gy)/30fr.) and two cycles of chemotherapy (5-FU 700 mg/m2, day 1-4, CDDP 70 mg/m2, day1, q4w) follwed by two cycles of adjuvant chemotherapy with 5-FU (700 mg/m2, day 1-5) plus cisplatin (70 mg/m2, day 1) repeated every 4 weeks.
20 | years-old | <= |
75 | years-old | >= |
Male and Female
i) cervical esophageal cancer with pathologically proven squamous cell carcinoma or adenosquamous cell carcinoma;
ii) Clinical stage II-III or IV with supraclavicular LN metastasis (UICC 7th edition, 2009) ;
iii) Aged 20 to 75 years old;
iv) ECOG PS of 0 to 2;
v) No prior chemotherapy against any malignancies;
vi) No prior radiotherapy against head and neck or chest region;
vii) Screening and diagnosis by an otorhinolaryngologist;
viii) Sufficeient organ functions;
ix) Written informed consent.
i) Simultaneous or metachronous (within 5 years) double cancers;
ii) Systemic infections disease;
iii) Body temperature of 38C or higher;
iv) Women during pregnancy or breast-feeding;
v) Psychiatric disease and/or depression;
vi) Continuous systemic steroids medication;
vii) HBs antigen positive;
viii) Uncontrollable diabetes mellitus;
ix) Uncontrollable hypertension;
x) Myocardial infarction within 6 months or unstable angina pectoris;
xi) Serious complications (interstitial pneumonia, pulmonary fibrosis, COPD, heart failure, etc.);
xii) cerebrovasucular disease within 6 months;
xiii) Histoty of collagen diseases;
xiv) History of surgery of esophagus
44
1st name | |
Middle name | |
Last name | Yasumasa Nishimura |
Medical Faculty, Kinki University.
Department of Radiation Oncology
377-2, Ono-higashi, Osaka-Sayama, Osaka, 589-8511, Japan
072-368-2388
ynishii@med.kindai.ca.jp
1st name | |
Middle name | |
Last name | Satoshi Itasaka |
JROSG 12-1 Coordinating Office
Department of Radiation Oncology, Kurashiki Central Hospital
1-1-1 Miwa, Kurashiki, Okayama, 710-8602, Japan
086-422-0210
http://www.jrosg.jp/protocol/protocol_list.html
sitasaka@kchnet.or.jp
Japanese Radiation Oncology Study Group(JROSG)
Ministry of Health, Labour and Welfare
Japanese Governmental office
NO
北海道大学病院(北海道)
札幌医科大学(北海道)
東北大学病院(宮城県)
国立がん研究センター東病院(千葉県)
国立がん研究センター中央病院(東京都)
埼玉県立がんセンター(埼玉県)
神奈川県立がんセンター(神奈川県)
群馬大学病院(群馬県)
愛知県がんセンター中央病院(愛知県)
京都大学医学部附属病院(京都府)
京都府立大学(京都府)
近畿大学医学部(大阪府)
大阪府立病院機構大阪府立成人病センター(大阪府)
広島大学病院(広島県)
兵庫県立がんセンター(兵庫県)
滋賀県立成人病センター(滋賀県)
倉敷中央病院(岡山県)
香川大学(香川県)
2013 | Year | 01 | Month | 28 | Day |
Unpublished
No longer recruiting
2013 | Year | 01 | Month | 15 | Day |
2013 | Year | 02 | Month | 16 | Day |
2020 | Year | 08 | Month | 31 | Day |
2013 | Year | 01 | Month | 28 | Day |
2018 | Year | 08 | Month | 08 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011462
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