Unique ID issued by UMIN | UMIN000016255 |
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Receipt number | R000018856 |
Scientific Title | Phase II clinical study of nab-PTX/CBDCA (administer 3-weeks on / 1-week off) for patients with clinical stage IIIB/IV or recurrent NSCLC |
Date of disclosure of the study information | 2015/01/19 |
Last modified on | 2018/07/22 14:35:49 |
Phase II clinical study of nab-PTX/CBDCA (administer 3-weeks on / 1-week off) for patients with clinical stage IIIB/IV or recurrent NSCLC
Phase II clinical study of nab-PTX/CBDCA for patients with clinical stage IIIB/IV or recurrent NSCLC
Phase II clinical study of nab-PTX/CBDCA (administer 3-weeks on / 1-week off) for patients with clinical stage IIIB/IV or recurrent NSCLC
Phase II clinical study of nab-PTX/CBDCA for patients with clinical stage IIIB/IV or recurrent NSCLC
Japan |
lung cancer
Chest surgery |
Malignancy
NO
The purpose of this study is to evaluate the effectivity and safty of nab-PTX/CBDCA (administer 3-weeks on / 1-week off) for patients with clinical stage IIIB/IV or recurrent NSCLC
Safety,Efficacy
Exploratory
Pragmatic
Phase II
response rate
progression free survival/overall survival/disease control rate/adverse events/completion rate of treatment
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
nab-Paclitaxel (100mg/m2) day 1,8,15 + CBDCA (AUC 6 ) day 1 : every 4 weeks (administer 3-weeks on / 1-week off) 4cycles
20 | years-old | <= |
Not applicable |
Male and Female
1.Histologically or cytologically confirmed nonsmall cell lung cancer.
2.clinical stage IIIB/IV or postoperative recurrence.
3.At least one mesurable lesion according to RECISTversion1.1.
4.Chemotherapy-naive patients or postoperative patients without adjuvant chemotherapy until 6 months before the registration.
5.With adequate organ function
5-1.neutrophil count => 1,500/mm^3
5-2.platelet => 100,000/mm^3
5-3.hemoglobin => 9.0g/dL
5-4.AST/ALT <= 2.5 times less than ULN
5-5.T.Bil <= 1.5mg/dL
5-6.serum creatinine <= 1.5mg/dL
5-7.Peripheral neuropathy <= Grade 1
6.Life expectancy of at least 3 months
7.ECOG performance status 0 or 1
8.With written informed consent
1.With severe myelosuppression.
2.With the history of hypersensitivity for nab-paclitaxel or CBDCA.
3.With active double cancer.
4.With active infectious disease:temperature=>38
5.With clinically important complications.
6.Interstitial pneumonia or pulmonary fibrosis on chest X-rays.
7.Pregnant females, possibly pregnant females, females wishing to become pregnant and nursing mothers. Males that are currently attempting to produce a pregnancy.
8.Accepted continuous use of steroid.
9.Physician concludes that the patient's participation in this trial is inappropriate.
5
1st name | |
Middle name | |
Last name | Jun Hanaoka |
Shiga University of Medical Science
Department of thoracic surgery
Seta-Tsukinowa, Otsu, Shiga
077-548-2244
hanaoka@belle.shiga-med.ac.jp
1st name | |
Middle name | |
Last name | Jun Hanaoka |
Shiga University of Medical Science
Department of thoracic surgery
Seta-Tsukinowa, Otsu, Shiga
077-548-2244
hanaoka@belle.shiga-med.ac.jp
Shiga University of Medical Science
None
Self funding
NO
2015 | Year | 01 | Month | 19 | Day |
Unpublished
Terminated
2015 | Year | 01 | Month | 19 | Day |
2015 | Year | 01 | Month | 19 | Day |
2015 | Year | 01 | Month | 18 | Day |
2018 | Year | 07 | Month | 22 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018856
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