Unique ID issued by UMIN | UMIN000018360 |
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Receipt number | R000021257 |
Scientific Title | radiotherapy combined with nedaplatin and 5-FU for postoperative locoregional recurrent esophageal cancer -phase II study- |
Date of disclosure of the study information | 2015/07/21 |
Last modified on | 2017/04/07 18:31:11 |
radiotherapy combined with nedaplatin and 5-FU for postoperative locoregional recurrent esophageal cancer -phase II study-
chemoradiotherapy for postoperative locoregional recurrent esophageal cancer
radiotherapy combined with nedaplatin and 5-FU for postoperative locoregional recurrent esophageal cancer -phase II study-
chemoradiotherapy for postoperative locoregional recurrent esophageal cancer
Japan |
postoperative locoregional (excluding hematogenous metastasis) recurrent esophageal cancer
Radiology |
Malignancy
NO
to evaluate the effectiveness and safety of radiotherapy combined with nedaplatin and 5-FU for postoperative locoregional (excluding hematogenous metastasis) recurrent esophageal cancer
Safety,Efficacy
overall survival rate
tumor response, relapse-free survival rate, irradiated-field control rate and toxicity
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine | Other |
chemoradiotherapy
30 | years-old | <= |
80 | years-old | >= |
Male and Female
1) Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 3,
2) no other active cancer,
3) no serious cardiac, liver, or pulmonary disease,
4) creatinine clearance of more than 50 ml/min,
5) adequate bone marrow function (leukocyte count of 4000/ul, platelet count of 100,000/ul,
6) locoregional recurrence (including para-aortic lymph node metastasis) without distant metastasis after no residual tumor (R0) resection; extended radical esophagectomy with three-field (neck, mediastinum, and abdomen) lymph node dissection,
and 7) no previous therapy other than R0 resection.
see above
30
1st name | |
Middle name | |
Last name | Keiichi Jingu |
Tohoku University Graduate School of Medicine
Department of Radiuation Oncology
Seiryo-machi 1-1, Aoba-ku, Sendai
+81-22-717-7312
kjingu-jr@rad.med.tohoku.ac.jp
1st name | |
Middle name | |
Last name | see above |
see above
see above
see above
-81-22-717-7312
kjingu-jr@rad.med.tohoku.ac.jp
Department of Radiuation Oncology, Tohoku University Graduate School of Medicine
none
Self funding
NO
2015 | Year | 07 | Month | 21 | Day |
Published
http://www.ncbi.nlm.nih.gov/pubmed/23171077
The 5-year overall survival rate was 27.0% with a median survival period of 21.0 months.
Completed
2000 | Year | 05 | Month | 01 | Day |
2000 | Year | 06 | Month | 01 | Day |
2012 | Year | 06 | Month | 30 | Day |
2015 | Year | 07 | Month | 21 | Day |
2017 | Year | 04 | Month | 07 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021257
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