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利用者名:
UMIN ID:

試験進捗状況 試験終了/Completed
UMIN試験ID UMIN000036556
受付番号 R000041431
科学的試験名 進行非小細胞肺癌に対するパクリタキセルとカルボプラチン併用療法(TJ 療法)のbiweekly 投与法とweekly 投与法のランダム化第Ⅱ相試験
一般公開日(本登録希望日) 2019/04/25
最終更新日 2019/04/20

※ 本ページ収載の情報は、臨床試験に関する情報公開を目的として、UMINが開設しているUMIN臨床試験登録システムに提供された臨床試験情報です。
※ 特定の医薬品や治療法等については、医療関係者や一般の方に向けて広告することは目的としていません。


基本情報/Basic information
一般向け試験名/Public title 進行非小細胞肺癌に対するパクリタキセルとカルボプラチン併用療法(TJ 療法)のbiweekly 投与法とweekly 投与法のランダム化第Ⅱ相試験 Randomized, phase II study of weekly paclitaxel plus carboplatin versus biweekly paclitaxel plus carboplatin for patients with previously untreated advanced non-small-cell lung cancer
一般向け試験名略称/Acronym LOGIK-0403 LOGIK-0403
科学的試験名/Scientific Title 進行非小細胞肺癌に対するパクリタキセルとカルボプラチン併用療法(TJ 療法)のbiweekly 投与法とweekly 投与法のランダム化第Ⅱ相試験 Randomized, phase II study of weekly paclitaxel plus carboplatin versus biweekly paclitaxel plus carboplatin for patients with previously untreated advanced non-small-cell lung cancer
科学的試験名略称/Scientific Title:Acronym LOGIK-0403 LOGIK-0403
試験実施地域/Region
日本/Japan アジア(日本以外)/Asia(except Japan)

対象疾患/Condition
対象疾患名/Condition 進行非小細胞肺癌 advanced non-small cell lung cancer (NSCLC)
疾患区分1/Classification by specialty
内科学一般/Medicine in general 呼吸器内科学/Pneumology
血液・腫瘍内科学/Hematology and clinical oncology 呼吸器外科学/Chest surgery
疾患区分2/Classification by malignancy 悪性腫瘍/Malignancy
ゲノム情報の取扱い/Genomic information いいえ/NO

目的/Objectives
目的1/Narrative objectives1 未治療進行非小細胞肺癌を対象に、パクリタキセル(TXL)とカルボプラチン(CBDCA)併用療法(TJ療法)の2種類の投与法をランダム割付し、その有用性を検討し、将来の第Ⅲ相比較試験の試験アームの選定を目的とする。 To compare the efficacy and safety of the weekly and biweekly CP regimen for patients with advanced NSCLC.
目的2/Basic objectives2 安全性/Safety
目的2 -その他詳細/Basic objectives -Others

試験の性質1/Trial characteristics_1 探索的/Exploratory
試験の性質2/Trial characteristics_2 実務的/Pragmatic
試験のフェーズ/Developmental phase 第Ⅱ相/Phase II

評価/Assessment
主要アウトカム評価項目/Primary outcomes 抗腫瘍効果(奏効率) Objective Response Rate (ORR)
副次アウトカム評価項目/Key secondary outcomes 有害事象発現割合、無増悪生存期間、全生存期間 Safety, Progression Free Survival, Overall Survival

基本事項/Base
試験の種類/Study type 介入/Interventional

試験デザイン/Study design
基本デザイン/Basic design 並行群間比較/Parallel
ランダム化/Randomization ランダム化/Randomized
ランダム化の単位/Randomization unit 個別/Individual
ブラインド化/Blinding オープン/Open -no one is blinded
コントロール/Control 実薬・標準治療対照/Active
層別化/Stratification
動的割付/Dynamic allocation
試験実施施設の考慮/Institution consideration
ブロック化/Blocking
割付コードを知る方法/Concealment

介入/Intervention
群数/No. of arms 2
介入の目的/Purpose of intervention 治療・ケア/Treatment
介入の種類/Type of intervention
医薬品/Medicine
介入1/Interventions/Control_1 A 群:Biweekly 投与法
TXL 135mg/m2 day1, 15+CBDCA AUC= 3 day1, 15
every 28 days for 4 cycles
A group: Biweekly treatment
TXL 135mg/m2 day1, 15+CBDCA(AUC=3)day1, 15
every 28 days for 4 cycles
介入2/Interventions/Control_2 B 群:Weekly 投与法
TXL 90mg/m2 day1, 8, 15+CBDCA AUC= 6 day1
every 28 days for 4 cycles
B group: Weekly treatment
TXL 90mg/m2 day1, 8, 15 + CBDCA(AUC=6) day1
every 28 days for 4 cycles
介入3/Interventions/Control_3

介入4/Interventions/Control_4

介入5/Interventions/Control_5

介入6/Interventions/Control_6

介入7/Interventions/Control_7

介入8/Interventions/Control_8

介入9/Interventions/Control_9

介入10/Interventions/Control_10


適格性/Eligibility
年齢(下限)/Age-lower limit
20 歳/years-old 以上/<=
年齢(上限)/Age-upper limit
80 歳/years-old 以下/>=
性別/Gender 男女両方/Male and Female
選択基準/Key inclusion criteria 細胞診または組織診で非小細胞肺癌が確認されている症例
臨床ⅢB 期(放射線治療不能症例)およびⅣ期の症例(術後遠隔転移はⅣ期として扱う)
本疾患に対する前化学療法を有さない症例
年齢20 歳以上80 歳以下
PS(ECOG) 0-1の症例
RECIST の基準による測定可能病変を有する症例
十分な主要臓器機能を有する症例
1) 白血球数 4,000/mm3 以上
または好中球2000/mm3 以上
2) 血小板数 10×104/mm3 以上
3) ヘモグロビン 9.0/dL 以上
4) GOT、GPT 施設正常値上限の2 倍以下
(但し、肝転移による異常値は正常値上限の3 倍以下)
5) 血清総ビリルビン 1.5mg/dL 以下
6) 血清クレアチニン 施設正常値上限値1.5 倍以下
7) 心電図 正常(重篤な心疾患・不整脈のない症例)
8) PaO2 60 torr 以上(またはSpO2 90%以上)
生存期間が3 ヶ月以上期待できる症例
本試験参加について本人から文書による同意が得られていること
Cases of non-small cell lung cancer confirmed by cytology or histology
Stage IIIB (radiotherapy-naive cases) and Stage IV (postoperative distant metastases are treated as Stage IV)
Cases without prior chemotherapy for this disease
Age 20 to 80 years
PS(ECOG) 0-1
Cases with measurable lesions according to RECIST criteria
Cases with adequate major organ function
1) WBC count > 4,000 per mm3 Or more than 2000 neutrophils per mm3
2) Platelets count > 10000 per mm3
3) Hemoglobin > 9.0/dL
4) GOTs, not more than 2 times the upper limit of normal at GPT institution
(However, abnormal values due to liver metastasis are not more than 3 times the upper limit of normal.)
5) Serum total bilirubin < 1.5 mg/dL
6) Upper limit of normal for serum creatinine 1.5-fold or less
7) Electrocardiogram normal (patients without serious heart disease or arrhythmia)
8) PaO2 60 torr or higher (or SpO2 90% or higher)
Patients with an expected survival of at least 3 months
Written informed consent has been obtained from the patient regarding participation in the study
除外基準/Key exclusion criteria 重篤な合併症を有する症例
例:重篤な心疾患または脳血管障害、コントロール困難な糖尿病または高血圧症、
重症感染症、肺線維症、間質性肺炎、呼吸不全、出血、多量の胸水または腹水貯
留、活動性の消化性潰瘍、重篤な神経疾患
有症状脳転移を有する症例
活動性の重複癌を有する症例
重篤な薬剤過敏症の既往歴のある症例
ポリオキシエチレンヒマシ油(クレモホールEL○R )含有製剤(シクロスポリン製剤)
および、硬化ヒマシ油含有製剤(注射用ビタミン剤など)の投与歴に関連して過敏
症が発現したことのある症例
アルコール過敏症の既往歴のある症例
妊婦、授乳婦および妊娠している可能性のある症例
精神病または精神症状を合併しており試験への参加が困難と判断される症例
ステロイド剤の継続的な全身投与(内服または静脈内)を受けている症例
その他、担当医が不適当と判断した症例
Cases with serious complications
(e.g., severe heart disease or cerebrovascular disorders, difficult-to-control diabetes or hypertension, Severe infection, pulmonary fibrosis, interstitial pneumonia, respiratory failure, hemorrhage, massive pleural effusion, or ascites, Retention, active peptic ulcers, and serious neurologic disease)
Cases with symptomatic brain metastases
Cases with active double cancers
Patients with a history of serious drug hypersensitivity
Polyoxyethylene castor oil-containing preparation (cyclosporine preparation)
Patients who have experienced hypersensitivity related to a history of administration of a sclerosed castor oil-containing preparation (e.g., an injectable vitamin preparation)
Cases with a history of alcohol hypersensitivity
Pregnant, lactating and possibly pregnant women
Patients with psychosis or psychiatric symptoms who are considered difficult to participate in the study
Patients receiving continuous systemic (oral or intravenous) corticosteroids
Other cases considered inappropriate by the attending physician
目標参加者数/Target sample size 140

責任研究者/Research contact person
責任研究者/Name of lead principal investigator
浩一
ミドルネーム
高山
Koichi
ミドルネーム
Takayama
所属組織/Organization 京都府立医科大学 Kyoto Prefectural University of Medicine
所属部署/Division name 呼吸器内科 Department of Pulmonary Medicine
郵便番号/Zip code 602-8566
住所/Address 京都市上京区河原町通広小路上る梶井町465 465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 602-8566, JAPAN.
電話/TEL 075-251-5513
Email/Email takayama@koto.kpu-m.ac.jp

試験問い合わせ窓口/Public contact
試験問い合わせ窓口担当者/Name of contact person
順治
ミドルネーム
内野
Junji
ミドルネーム
Uchino
組織名/Organization 京都府立医科大学 Kyoto Prefectural University of Medicine
部署名/Division name 呼吸器内科 Department of Pulmonary Medicine
郵便番号/Zip code 602-8566
住所/Address 京都市上京区河原町通広小路上る梶井町465 465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 602-8566, JAPAN.
電話/TEL 075-251-5513
試験のホームページURL/Homepage URL
Email/Email uchino@koto.kpu-m.ac.jp

実施責任組織/Sponsor
機関名/Institute その他 Clinical Research Support Center Kyushu
機関名/Institute
(機関選択不可の場合)
一般社団法人九州臨床研究支援センター
部署名/Department

研究費提供組織/Funding Source
機関名/Organization 自己調達 self funding
機関名/Organization
(機関選択不可の場合)

組織名/Division
組織の区分/Category of Funding Organization 自己調達/Self funding
研究費拠出国/Nationality of Funding Organization


その他の関連組織/Other related organizations
共同実施組織/Co-sponsor

その他の研究費提供組織/Name of secondary funder(s)


IRB等連絡先(公開)/IRB Contact (For public release)
組織名/Organization 京都府立医科大学 Kyoto Prefectural University of Medicine
住所/Address 京都市上京区河原町通広小路上る梶井町465 465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 602-8566, JAPAN.
電話/Tel 075-251-5513
Email/Email uchino@koto.kpu-m.ac.jp

他機関から発行された試験ID/Secondary IDs
他機関から発行された試験ID/Secondary IDs いいえ/NO
試験ID1/Study ID_1
ID発行機関1/Org. issuing International ID_1

試験ID2/Study ID_2
ID発行機関2/Org. issuing International ID_2

治験届/IND to MHLW

試験実施施設/Institutions
試験実施施設名称/Institutions

その他の管理情報/Other administrative information
一般公開日(本登録希望日)/Date of disclosure of the study information
2019 04 25

関連情報/Related information
プロトコル掲載URL/URL releasing protocol N/A
試験結果の公開状況/Publication of results 中間解析等の途中公開/Partially published

結果/Result
結果掲載URL/URL related to results and publications N/A
組み入れ参加者数/Number of participants that the trial has enrolled 140
主な結果/Results
Objective response rates (ORRs) were 29.6% (B) and 37.6% (W). The most common toxicity was neutropenia, 49.0% (W) and 52.3% (W). Progression free survivals were 4.3m (B) and 5.1 m (W) in Japanese, and 3.1m (B) and 6.7m (W) in Korean, respectively. Overall survivals were 14.2m (B) and 13.3m (W) in Japanese, and 12.7m (B) and 22.1m (W) in Korean, respectively.
Objective response rates (ORRs) were 29.6% (B) and 37.6% (W). The most common toxicity was neutropenia, 49.0% (W) and 52.3% (W). Progression free survivals were 4.3m (B) and 5.1 m (W) in Japanese, and 3.1m (B) and 6.7m (W) in Korean, respectively. Overall survivals were 14.2m (B) and 13.3m (W) in Japanese, and 12.7m (B) and 22.1m (W) in Korean, respectively.
主な結果入力日/Results date posted
2019 04 20
結果掲載遅延/Results Delayed
結果遅延理由/Results Delay Reason

最初の試験結果の出版日/Date of the first journal publication of results
参加者背景/Baseline Characteristics
140 patients in Japan and 72 patients in Korea were enrolled onto the study at 13 sites in Japan and 4 sites in Korea. After excluding 5 ineligible cases, 135 patients in Japan and 72 patients in Korea were assessed.
140 patients in Japan and 72 patients in Korea were enrolled onto the study at 13 sites in Japan and 4 sites in Korea. After excluding 5 ineligible cases, 135 patients in Japan and 72 patients in Korea were assessed.
参加者の流れ/Participant flow
In the biweekly arm, the average number of cycles was 2.8, and 45% of patients received 4 cycles. In the weekly arm, the average number of cycles was 3.0, and 53% of patients received 4 cycles. The median number of cycles in both arms was 3 and 3 for the biweekly and weekly arm, respectively. 
In the biweekly arm, the average number of cycles was 2.8, and 45% of patients received 4 cycles. In the weekly arm, the average number of cycles was 3.0, and 53% of patients received 4 cycles. The median number of cycles in both arms was 3 and 3 for the biweekly and weekly arm, respectively. 
有害事象/Adverse events
Neutropenia was the most common hematologic toxicity in total and each country with no statistical difference between weekly arm and biweekly arm, 52.3% vs. 49.0%, respectively. Anemia, leucopenia and thrombocytepenia were significantly higher in the weekly arm compared with those in biweekly arm, 21.2% vs. 2.0% (p<0.01), 30.3% vs. 15.3% (p<0.05) and 6.4% vs. 0% (p<0.05), respectively. Although the similar trend was noted in both countries, hematologic toxicities were more frequent in Japan than Korea. Non-hematological toxicities were generally mild and manageable in both countries. However, it is important to note that the frequency of infection was significantly higher in biweekly arm, 1.8% vs. 11.2%, respectively (p<0.01). Moreover, two patients died as a result of pneumonia in the biweekly arm in Korea. Since the grade of hematologic toxicities were generally low intensity in biweekly arm as described above, other factors except myelosupprssion may be associated with the infectious disease.
Neutropenia was the most common hematologic toxicity in total and each country with no statistical difference between weekly arm and biweekly arm, 52.3% vs. 49.0%, respectively. Anemia, leucopenia and thrombocytepenia were significantly higher in the weekly arm compared with those in biweekly arm, 21.2% vs. 2.0% (p<0.01), 30.3% vs. 15.3% (p<0.05) and 6.4% vs. 0% (p<0.05), respectively. Although the similar trend was noted in both countries, hematologic toxicities were more frequent in Japan than Korea. Non-hematological toxicities were generally mild and manageable in both countries. However, it is important to note that the frequency of infection was significantly higher in biweekly arm, 1.8% vs. 11.2%, respectively (p<0.01). Moreover, two patients died as a result of pneumonia in the biweekly arm in Korea. Since the grade of hematologic toxicities were generally low intensity in biweekly arm as described above, other factors except myelosupprssion may be associated with the infectious disease.
評価項目/Outcome measures
ORRs in the biweekly and weekly arm were 29.6% and 37.6%, respectively. Although weekly arm showed the higher response rate, there was no significant difference between two arms (p=0.24). The ORR was 28.1% in the biweekly arm and 38.0% in the weekly arm in Japanese population (p=0.27), and 32.4% in the biweekly arm and 36.8% in the weekly arm in Korean population (p=0.81). No statistical difference in the response rate in the biweekly and weekly regimens was noted in each country. In Japan, however, the response rate of 38.0% in the weekly arm was significantly higher than the threshold response rate (p=0.01). On the other hand, the ORR of the biweekly regimen was not significant (p=0.33). In Korea, the ORR in the weekly arm also tended to be higher than the threshold (p=0.07). 
ORRs in the biweekly and weekly arm were 29.6% and 37.6%, respectively. Although weekly arm showed the higher response rate, there was no significant difference between two arms (p=0.24). The ORR was 28.1% in the biweekly arm and 38.0% in the weekly arm in Japanese population (p=0.27), and 32.4% in the biweekly arm and 36.8% in the weekly arm in Korean population (p=0.81). No statistical difference in the response rate in the biweekly and weekly regimens was noted in each country. In Japan, however, the response rate of 38.0% in the weekly arm was significantly higher than the threshold response rate (p=0.01). On the other hand, the ORR of the biweekly regimen was not significant (p=0.33). In Korea, the ORR in the weekly arm also tended to be higher than the threshold (p=0.07). 
個別症例データ共有計画/Plan to share IPD

個別症例データ共有計画の詳細/IPD sharing Plan description


試験進捗状況/Progress
試験進捗状況/Recruitment status 試験終了/Completed
プロトコル確定日/Date of protocol fixation
2004 11 08
倫理委員会による承認日/Date of IRB
2005 04 18
登録・組入れ開始(予定)日/Anticipated trial start date
2005 12 01
フォロー終了(予定)日/Last follow-up date
2010 09 30
入力終了(予定)日/Date of closure to data entry
データ固定(予定)日/Date trial data considered complete
解析終了(予定)日/Date analysis concluded

その他/Other
その他関連情報/Other related information


管理情報/Management information
登録日時/Registered date
2019 04 20
最終更新日/Last modified on
2019 04 20


閲覧ページへのリンク/Link to view the page
URL(日本語) https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000041431
URL(英語) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041431

研究計画書
登録日時 ファイル名

研究症例データ仕様書
登録日時 ファイル名

研究症例データ
登録日時 ファイル名


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