UMIN-CTR 臨床試験登録情報の閲覧

一般向け試験名/Public title

日本語
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

英語
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

日本語
LOGIK-0403

英語
LOGIK-0403

科学的試験名/Scientific Title

日本語
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

英語
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

日本語
LOGIK-0403

英語
LOGIK-0403

試験実施地域/Region

日本/Japan	アジア（日本以外）/Asia(except Japan)

対象疾患名/Condition

日本語
進行非小細胞肺癌

英語
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1/Narrative objectives1

日本語
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。

英語
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

日本語

英語

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

主要アウトカム評価項目/Primary outcomes

日本語
抗腫瘍効果（奏効率）

英語
Objective Response Rate (ORR)

副次アウトカム評価項目/Key secondary outcomes

日本語
有害事象発現割合、無増悪生存期間、全生存期間

英語
Safety, Progression Free Survival, Overall Survival

試験の種類/Study type

介入/Interventional

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

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

日本語
A 群：Biweekly 投与法
TXL 135mg/m2 day1, 15＋CBDCA AUC= 3 day1, 15
every 28 days for 4 cycles

英語
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

日本語
B 群：Weekly 投与法
TXL 90mg/m2 day1, 8, 15＋CBDCA AUC= 6 day1
every 28 days for 4 cycles

英語
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

日本語

英語

介入4/Interventions/Control_4

日本語

英語

介入5/Interventions/Control_5

日本語

英語

介入6/Interventions/Control_6

日本語

英語

介入7/Interventions/Control_7

日本語

英語

介入8/Interventions/Control_8

日本語

英語

介入9/Interventions/Control_9

日本語

英語

介入10/Interventions/Control_10

日本語

英語

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

日本語
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

英語
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

日本語
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

英語
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/Name of lead principal investigator

日本語

名	浩一
ミドルネーム
姓	高山

英語

名	Koichi
ミドルネーム
姓	Takayama

所属組織/Organization

日本語
京都府立医科大学

英語
Kyoto Prefectural University of Medicine

所属部署/Division name

日本語
呼吸器内科

英語
Department of Pulmonary Medicine

郵便番号/Zip code

602-8566

住所/Address

日本語
京都市上京区河原町通広小路上る梶井町465

英語
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担当者/Name of contact person

日本語

名	順治
ミドルネーム
姓	内野

英語

名	Junji
ミドルネーム
姓	Uchino

組織名/Organization

日本語
京都府立医科大学

英語
Kyoto Prefectural University of Medicine

部署名/Division name

日本語
呼吸器内科

英語
Department of Pulmonary Medicine

郵便番号/Zip code

602-8566

住所/Address

日本語
京都市上京区河原町通広小路上る梶井町465

英語
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

機関名/Institute

日本語
その他

英語
Clinical Research Support Center Kyushu

機関名/Institute
（機関選択不可の場合）

日本語
一般社団法人九州臨床研究支援センター

部署名/Department

日本語

個人名/Personal name

日本語

英語

機関名/Organization

日本語
自己調達

英語
self funding

機関名/Organization
（機関選択不可の場合）

日本語

組織名/Division

日本語

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

日本語

英語

共同実施組織/Co-sponsor

日本語

英語

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

日本語

英語

組織名/Organization

日本語
京都府立医科大学

英語
Kyoto Prefectural University of Medicine

住所/Address

日本語
京都市上京区河原町通広小路上る梶井町465

英語
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

いいえ/NO

試験ID1/Study ID_1

ID発行機関1/Org. issuing International ID_1

日本語

英語

試験ID2/Study ID_2

ID発行機関2/Org. issuing International ID_2

日本語

英語

治験届/IND to MHLW

試験実施施設名称/Institutions

一般公開日（本登録希望日）/Date of disclosure of the study information

2019

年

04

月

25

日

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

日本語
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.

英語
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

年

04

月

20

日

結果掲載遅延/Results Delayed

結果遅延理由/Results Delay Reason

日本語

英語

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

日本語
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.

英語
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

日本語
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.

英語
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

日本語
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.

英語
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

日本語
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).

英語
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

日本語

英語

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

日本語

英語

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

年

11

月

08

日

倫理委員会による承認日/Date of IRB

2005

年

04

月

18

日

登録・組入れ開始（予定）日/Anticipated trial start date

2005

年

12

月

01

日

フォロー終了(予定)日/Last follow-up date

2010

年

09

月

30

日

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

その他関連情報/Other related information

日本語

英語

登録日時/Registered date

2019

年

04

月

20

日

最終更新日/Last modified on

2019

年

04

月

20

日

閲覧ページへのリンク/Link to view the page

日本語
https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000041431

英語
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041431