Unique ID issued by UMIN | UMIN000005389 |
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Receipt number | R000006398 |
Scientific Title | Phase I/ II study of S-1 and cisplatin with concurrent radiotherapy for locally advanced non-small-cell lung cancer. |
Date of disclosure of the study information | 2011/04/06 |
Last modified on | 2011/04/06 16:25:23 |
Phase I/ II study of S-1 and cisplatin with concurrent radiotherapy for locally advanced non-small-cell lung cancer.
S-1 and cisplatin with concurrent radiotherapy for NSCLC.
Phase I/ II study of S-1 and cisplatin with concurrent radiotherapy for locally advanced non-small-cell lung cancer.
S-1 and cisplatin with concurrent radiotherapy for NSCLC.
Japan |
Lung cancer
Pneumology |
Malignancy
NO
To evaluate the feasibility and efficacy of S-1 and cisplatin with concurrent thoracic radiation for unresectable stage III non-small-cell lung cancer.
Safety,Efficacy
Exploratory
Phase I,II
2-year survival rate
objective response rate,overall survival,progression-free survival,toxicity
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Level 1;
CDDP 60 mg/m2, day 8
S-1 80 mg/m2 days 1-14 every 3weeks
Level 2;
CDDP 60 mg/m2, day 8
S-1 80 mg/m2 days 1-21 every 4weeks
Thoracic radiation 60Gy/30fr
20 | years-old | <= |
75 | years-old | >= |
Male and Female
Eligibility criteria were: histological or cytological diagnosis of unresectable stage III NSCLC; no prior chemotherapy; measurable lesions; PS (ECOG) 0-1; adequate hematology and biochemistry parameters; and informed consent.
Exclusion criteria were:active concomitant malignancy; active pulmonary fibrosis or interstitial pneumonia ; watery diarrhea; serious complications; pregnancy; psychotic disorder; and drug allergy.
45
1st name | |
Middle name | |
Last name | Kiyotaka Yoh |
National Cancer Center Hospital East
Division of Thoracic Oncology
6-5-1,Kashiwanoha,Kashiwa-shi,Chiba-ken,277-8577
04-7133-1111
1st name | |
Middle name | |
Last name | Tetsuhiko Taira |
National Cancer Center Hospital East
Division of Thoracic Oncology
6-5-1,Kashiwanoha,Kashiwa-shi,Chiba-ken,277-8577
National Cancer Center Hospital East
National Cancer Center Hospital East
Self funding
Japan
NO
国立がん研究センター東病院
2011 | Year | 04 | Month | 06 | Day |
Unpublished
No longer recruiting
2005 | Year | 07 | Month | 28 | Day |
2005 | Year | 08 | Month | 01 | Day |
2012 | Year | 08 | Month | 01 | Day |
2011 | Year | 04 | Month | 06 | Day |
2011 | Year | 04 | Month | 06 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006398
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