Unique ID issued by UMIN | UMIN000001779 |
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Receipt number | R000002144 |
Scientific Title | Feasibility study of TS-1 after surgery with Cisplatin/Docetaxel in completely resected pathological stage II/IIIA non-small cell lung cancer (TORG0809) |
Date of disclosure of the study information | 2009/04/01 |
Last modified on | 2016/09/21 18:58:17 |
Feasibility study of TS-1 after surgery with Cisplatin/Docetaxel in completely resected pathological stage II/IIIA non-small cell lung cancer (TORG0809)
TS-1 after surgery with CDDP+Docetaxel for p-stage II/IIIA NSCLC(TORG0809)
Feasibility study of TS-1 after surgery with Cisplatin/Docetaxel in completely resected pathological stage II/IIIA non-small cell lung cancer (TORG0809)
TS-1 after surgery with CDDP+Docetaxel for p-stage II/IIIA NSCLC(TORG0809)
Japan |
Non-small Cell Lung Cancer
Pneumology | Chest surgery |
Malignancy
NO
To evaluate the feasibility of TS-1 after surgery with Cisplatin+Docetaxel for completely resected pathological stage II/IIIA non-small cell lung cancer.
Safety,Efficacy
Exploratory
Pragmatic
Phase II
treatment completion proportion
overall survival, relapse free survival, pattern of recurrence, adverse events
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
After CDDP 80mg/m2 + Docetaxel 60mg/m2, day 1 q3-4w, 3 courses, TS-1 80mg/m2 b.i.d., day 1-14 q3w, more than 6 months, maximum 1 year
20 | years-old | <= |
75 | years-old | > |
Male and Female
1) pathologically proven Non-small Cell Lung Cancer
2) pathological stage II, IIIA
3) complete resection
4) at least lobectomy
5) LN dissection (ND2a) or Elective Lymph Node Dissection
6) no prior anti cancer treatment for thoracic malignancy except for this operation
7) ECOG PS 0-1
8) more than 20 years of age, under 75 years of age
9) adequate organ function
10) within 10 weeks after surgery
11) signed informed consent
1) not recovered from surgical complications
2) active infection such as bacterial infection
3) patients with interstitial pneumonaitis or pulmonary fibrosis, as determined by chest CT
4) patients with myocardial infraction within 6 months
5) patinets with uncontroled complications
6) grade 2 or greater peripheral neuropathy
7) active concomitant malignancy
8) pregnant or lactating woman
9) past history of allergic reactions to polysorbate 80
10) concomitant therapy with flucytocine
11) pneumonectomy
12) other conditions not suitable for this study
125
1st name | |
Middle name | |
Last name | Norihiko Ikeda |
Tokyo Medical University
Department of Thoracic Surgery
6-7-1, Nishi-shinjuku, Shinjuku-ku, Tokyo 160-0023, JAPAN
03-3351-6141
ikeda@wd5.so-net.ne.jp
1st name | |
Middle name | |
Last name | Seiji Niho |
National Cancer Center Hospital East
Thoracic Oncology Division
6-5-1, Kashiwanoha, Kashiwa Chiba 277-8577, Japan
04-7133-1111
siniho@east.ncc.go.jp
Thoracic Oncology Research Group (TORG)
TAIHO PHARMACEUTICAL CO.,LTD.
Profit organization
NO
2009 | Year | 04 | Month | 01 | Day |
Partially published
Main results already published
2009 | Year | 02 | Month | 17 | Day |
2009 | Year | 04 | Month | 01 | Day |
2016 | Year | 03 | Month | 01 | Day |
2009 | Year | 03 | Month | 17 | Day |
2016 | Year | 09 | Month | 21 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002144
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