Unique ID issued by UMIN | UMIN000012989 |
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Receipt number | R000015086 |
Scientific Title | Phase II study of Carboplatin plus nab-Paclitaxel for advanced non-small cell lung cancer patients with interstitial lung disease |
Date of disclosure of the study information | 2014/02/03 |
Last modified on | 2020/07/16 09:33:25 |
Phase II study of Carboplatin plus nab-Paclitaxel for advanced non-small cell lung cancer patients with interstitial lung disease
Phase II study of CBDCA plus nab-PTX for advanced NSCLC patients with ILD
Phase II study of Carboplatin plus nab-Paclitaxel for advanced non-small cell lung cancer patients with interstitial lung disease
Phase II study of CBDCA plus nab-PTX for advanced NSCLC patients with ILD
Japan |
Advanced non-small cell lung cancer with interstitial lung disease
Pneumology | Hematology and clinical oncology |
Malignancy
NO
To evaluate safety and efficacy of the combination of nab-Paclitaxel with Carboplatin for advanced non-small cell lung cancer patients with interstitial lung disease
Safety,Efficacy
Confirmatory
Phase II
Exacerbation-free rate of ILD at 28 days after protocol treatment
Response rate, Progression-free survival, Overall survival, Exacerbation-free rate of ILD, Toxicities
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
4-6 cycles of chemotherapy with nab-Paclitaxl (100 mg/m2/day, day 1, 8, 15) and Carboplatin (AUC=6, day 1) repeated every 3 weeks
20 | years-old | <= |
Not applicable |
Male and Female
1) Histologically or cytologically proven non-small cell lung carcinoma
2) Clinical stage III, IV or recurrent disease after surgery
3) Diagnosed as interstitial lung disease
4) Severity of interstitial lung disease is mild or moderate
5) 20 years of age or older
6) ECOG performance status of 0 or 1
7) No prior chemotherapy for non-small cell lung cancer
8) No prior thoracic radiotherapy
9) With measurable or assessable lesions based on Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
10) No prior palliative radiotherapy for metastatic lesion within 14 days before registration
11) Adequate organ function
12) Estimated life expectancy of at least 12 weeks
13) Written informed consent
1) Synchronous or metachronous active double malignancies
2) Other lung disease, including infection, pneumoconiosis, drug-induced pneumonitis, sarcoidosis, and collagen vasucular disease
3) With symptomatic central nervous system metastases
4) Hypersensitvity to platinum or paclitaxel
5) Receiving systemic treatment with steroid or immunosuppressant
6) Positive for hepatitis B surface antigen
7) Women who are currently pregnant or will not be compliant with a medically approved contraceptive regimen during the treatment period and lactating women.
8) Men who will not be compliant with a contraceptive regimen during and for the treatment period
9) Psychotic disorder which prevent the patient from giving informed consent
10) Other criteria judged by the investigator to make a patient unsuitable for the study
90
1st name | Terufumi |
Middle name | |
Last name | Kato |
Kanagawa Cancer Center
Department of Thoracic Oncology
241-8515
2-3-2 Nakao, Asahi-ku, Yokohama 241-8515, Japan
045-520-2222
katote@kcch.jp
1st name | Hirotsugu |
Middle name | |
Last name | Kenmotsu |
Shizuoka Cancer Center
Division of Thoracic Oncology
411-8777
1007 Shimonagakubo Nagaizumi-cho Sunto-gun,Shizuoka, Japan, 411-8777
055-989-5222
h.kenmotsu@scchr.jp
Kanagawa Cardiovascular and Respiratory Center
The study group on diffuse pulmonary disorders
Japanese Governmental office
Shizuoka Cancer Center IRB
1007 Shimonagakubo, Nagaizumi-cho
0559895222
h.kenmotsu@scchr.jp
NO
国立がん研究センター中央病院(東京都)、横浜市立市民病院(神奈川県)、国立がん研究センター東病院(千葉県)、岡山大学(岡山県)、和歌山県立医科大学(和歌山県)、順天堂大学医学部附属順天堂医院(東京)、埼玉医科大学国際医療センター(埼玉県)、神奈川県立循環器呼吸器病センター(神奈川県)、静岡県立静岡がんセンター(静岡県)
2014 | Year | 02 | Month | 03 | Day |
Unpublished
Main results already published
2013 | Year | 12 | Month | 16 | Day |
2014 | Year | 04 | Month | 22 | Day |
2014 | Year | 06 | Month | 10 | Day |
2018 | Year | 01 | Month | 09 | Day |
2014 | Year | 01 | Month | 28 | Day |
2020 | Year | 07 | Month | 16 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015086
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