Unique ID issued by UMIN | UMIN000005031 |
---|---|
Receipt number | R000005982 |
Scientific Title | A Study on the efficacy and safety of Docetaxel plus Nedaplatin in patients with advanced non-small-cell lung cancer |
Date of disclosure of the study information | 2011/02/05 |
Last modified on | 2011/02/05 13:13:07 |
A Study on the efficacy and safety of Docetaxel plus Nedaplatin in patients with advanced non-small-cell lung cancer
A Study on the efficacy and safety of Docetaxel plus Nedaplatin in patients with advanced non-small-cell lung cancer
A Study on the efficacy and safety of Docetaxel plus Nedaplatin in patients with advanced non-small-cell lung cancer
A Study on the efficacy and safety of Docetaxel plus Nedaplatin in patients with advanced non-small-cell lung cancer
Japan |
non-small-cell lung cancer
Pneumology | Chest surgery |
Malignancy
NO
To evaluate the efficacy and safety of docetaxel plus nedaplatin in patients with advanced non-small-cell lung cancer
Safety,Efficacy
Exploratory
Pragmatic
Phase II
Efficacy
Satety
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Docetaxel (60mg/m2) (day 1)+
Nedaplatin (80mg/m2) (day 1)
q3-4weeks, 2-4 cycles
20 | years-old | <= |
79 | years-old | >= |
Male and Female
1. Histologically determined non-small cell lung cancer
2. Measurable tumor sites
3. Clinical stage, IIIB or IV
4. Neither previous cancer therapy ( operation, chemotherapy and radiotherapy)
5. Aged 20-79 years old
6. ECOG performance status 0 or 1
7. Adequate organ functions
8. Life expectancy more than 3 months
9. Written informed consent
1. Allergy against polysorbert 80 or platinum-containing drugs
2. Severe complications
(i.e. ischemic heart diseases required treatment, arrhythmia, myocardial infarction within 6 months, liver cirrhosis, uncontrolled diabetes,hemorrhagic tendency )
3. Active infections
4. Massive pleural or pericardial effusion
5. Brain metastases with neurological symptoms.
6. Active simultaneous cancer
7. Active interstitial pneumonitis or its past history
8. Peripheral nerve disorder
9. Pregnant or lactating women
10. Other conditions not suitable for this study
40
1st name | |
Middle name | |
Last name | Shozo Fujino |
Teikyo University School of Medicine University Hospital, Mizonokuchi
Department of Surgery
3-8-3, Mizonokuchi, Takatsu-ku, Kawasaki, Kanagawa
1st name | |
Middle name | |
Last name | Koji Teramoto |
Shiga University of Medical Science
Department of Surgery
Seta-Tsukinowa, Otsu, Shiga
077-548-2244
teramoto@belle.shiga-med.ac.jp
Shiga University of Medical Science
None
Self funding
NO
滋賀医科大学医学部附属病院(滋賀県)
長浜赤十字病院(滋賀県)
国立病院機構滋賀病院(滋賀県)
医仁会武田総合病院(京都府)
2011 | Year | 02 | Month | 05 | Day |
Published
(Patients background)
Enrolled patients:46
Male/Female=39/7, PS 0/1=27/19, IIIB/IV=20/27
Sq/Ad/NSCLC/AdSq=12/25/8/
Total cycles administered:144 cycles(mean:3.1 cycles)
(Efficacy)
CR/PR/SD/PD=0/24/11/11
Objective response rate 52.2% (24/46)
(Safety)
Grade 3-
Leukopenia 29.2%
Nausea/vomiting 3.5%
Anorexia 4.2%
Completed
2004 | Year | 01 | Month | 26 | Day |
2004 | Year | 03 | Month | 01 | Day |
Published in ASCO annual meetnig 2007
2011 | Year | 02 | Month | 05 | Day |
2011 | Year | 02 | Month | 05 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005982
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |