Unique ID issued by UMIN | UMIN000013219 |
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Receipt number | R000015425 |
Scientific Title | Phase I/II trial of nab-PTX/CDGP for chemo-naive patients with advanced squamous cell lung cancer (KRSG-1302) |
Date of disclosure of the study information | 2014/02/21 |
Last modified on | 2022/08/03 14:44:57 |
Phase I/II trial of nab-PTX/CDGP for chemo-naive patients with advanced squamous cell lung cancer (KRSG-1302)
Phase I/II trial of nab-PTX/CDGP for patients with advanced squamous cell lung cancer (KRSG-1302)
Phase I/II trial of nab-PTX/CDGP for chemo-naive patients with advanced squamous cell lung cancer (KRSG-1302)
Phase I/II trial of nab-PTX/CDGP for patients with advanced squamous cell lung cancer (KRSG-1302)
Japan |
Squamous cell lung cancer
Pneumology |
Malignancy
NO
The purpose of this study is to determine the recommended dose of nab-paclitaxel plus nedaplatin in chemo-naive patients with advanced squamous cell lung cancer and to assess the efficacy and safety with recommended dose.
Safety,Efficacy
Phase I,II
Phase I: To determine the maximum tolerated dose and to estimate the recommended dose
Phase II: response rate
Phase I: Safety, Response rate
Phase II: Progression-free survival, Overall survival, safety
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Phase I
LEVEL2
nab-PTX: 100 mg/m2 (day1,8,15; q3w)
CDGP: 100 mg/m2 (day1; q3w)
LEVEL1
nab-PTX: 100 mg/m2 (day1,8, q3w)
CDGP: 100 mg/m2 (day1; q3w)
LEVEL0
nab-PTX: 100 mg/m2 (day1,8, q3w)
CDGP: 80 mg/m2 (day1; q3w)
LEVEL-1
nab-PTX: 80 mg/m2 (day1,8, q3w)
CDGP 80: mg/m2 (day1; q3w)
Phase II
nab-PTX: RD, Recommended schedule
CDGP: RD (day1; q3w)
20 | years-old | <= |
75 | years-old | > |
Male and Female
1) Definitively diagnosed with squamous cell lung cancer by the specimens histologically or cytologically.
2) Stage III/IV without any indications for radiotherapy
3) No prior chemotherapy
Adjuvant chemotherapy of UFT finished before 4 weeks from enrollment or more is permitted.
4) With a measurable lesion
5) Age of 20 to 75 years
6) Without active cancer other than NSCLC
7) ECOG performance status 0 or 1
8) With adequate organ function
1) Symptomatic brain metastasis
2) Pregnant females, possibly pregnant females, females wishing to become pregnant and nursing mothers. Males that are currently attempting to produce a pregnancy
3) With active double cancer or multicentric cancer
4) .>= G2 peripheral neuropathy (CTCAE)
5) Treated with radiotherapy within the past four weeks.
6) With clinically important complications.
7) Interstitial pneumonia or pulmonary fibrosis becomes the clinical problem
8) With pleural effusion or pericardial effusion accumulates which need drainage
9) With the history of hypersensivity for component of human plasma with albumin, nab-PTX, or CDGP
10) Main organs had a serious medical risk factor, and the physicians judged treatment not to be safe.
11) Physician concludes that the patient's participation in this trial is inappropriate
23
1st name | |
Middle name | |
Last name | Takashi Kasai |
Tochigi Cancer Center
Division of Thoracic Oncology
4-9-13 Yonan Utsunomiya City Tochigi
028-658-5151
takasai@tcc.pref.tochigi.lg.jp
1st name | |
Middle name | |
Last name | Takashi Kasai |
Tochigi Cancer Center
Division of Thoracic Oncology
4-9-13 Yonan Utsunomiya City Tochigi
028-658-5151
takasai@tcc.pref.tochigi.lg.jp
Kanto respiratory disease study group
None
Self funding
NO
2014 | Year | 02 | Month | 21 | Day |
Unpublished
Completed
2013 | Year | 07 | Month | 29 | Day |
2013 | Year | 07 | Month | 11 | Day |
2013 | Year | 07 | Month | 29 | Day |
2021 | Year | 12 | Month | 31 | Day |
2021 | Year | 12 | Month | 31 | Day |
2014 | Year | 02 | Month | 21 | Day |
2022 | Year | 08 | Month | 03 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015425
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