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UMIN-CTR 臨床試験登録情報の閲覧 |
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利用者名 | UMIN ID |
試験進捗状況 | 限定募集中/Enrolling by invitation |
UMIN試験ID | UMIN000007525 |
受付番号 | R000008887 |
科学的試験名 | 原発性肺癌術後補助療法における化学療法と樹状細胞、活性化リンパ球の第III相比較試験 |
一般公開日(本登録希望日) | 2012/04/01 |
最終更新日 | 2015/04/22 |
基本情報/Basic information | |||
一般向け試験名/Public title | 原発性肺癌術後補助療法における化学療法と樹状細胞、活性化リンパ球の第III相比較試験 | Randomized phase III trial of adjuvant chemo-immunotherapy with dendritic cells and activated killer cells in patients with resected primary lung cancer patients | |
一般向け試験名略称/Acronym | 肺がん術後アジュバント免疫療法 | Immunotherapy for post-surgical lung cancer patients | |
科学的試験名/Scientific Title | 原発性肺癌術後補助療法における化学療法と樹状細胞、活性化リンパ球の第III相比較試験 | Randomized phase III trial of adjuvant chemo-immunotherapy with dendritic cells and activated killer cells in patients with resected primary lung cancer patients | |
科学的試験名略称/Scientific Title:Acronym | 肺がん術後アジュバント免疫療法 | Immunotherapy for post-surgical lung cancer patients | |
試験実施地域/Region |
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対象疾患/Condition | |||||
対象疾患名/Condition | 原発性肺がん | Primary lung cancer | |||
疾患区分1/Classification by specialty |
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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 | 肺がん切除後の再発予防に対する化学療法と樹状細胞、活性化リンパ球の併用効果を化学療法単独群と生存率と非再発生存期間で比較する | To compare the survival and recurrence free survival in the phase III study of post surgical lung cancer patients. group A: patients who received postsurgical immunotherapy and chemotherapy with activated killer cells and dendritic cells . Group B: patients who received chemotherapy alone. |
目的2/Basic objectives2 | 有効性/Efficacy | |
目的2 -その他詳細/Basic objectives -Others | ||
試験の性質1/Trial characteristics_1 | 検証的/Confirmatory | |
試験の性質2/Trial characteristics_2 | 実務的/Pragmatic | |
試験のフェーズ/Developmental phase | 第Ⅲ相/Phase III |
評価/Assessment | ||
主要アウトカム評価項目/Primary outcomes | 生存率、2年生存率、5年生存率 | 2 year survival,5 year survival |
副次アウトカム評価項目/Key secondary outcomes | 非再発生存期間、安全性、副作用 | recurrence free survival, safety,
seide effect |
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 | 集団/Cluster | |
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 | はい/YES | |
動的割付/Dynamic allocation | はい/YES | |
試験実施施設の考慮/Institution consideration | 施設を考慮していない/Institution is not considered as adjustment factor. | |
ブロック化/Blocking | いいえ/NO | |
割付コードを知る方法/Concealment | 中央登録/Central registration |
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 |
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介入1/Interventions/Control_1 | A 群 免疫療法+化学療法
化学療法はCBDCAを含む2剤併用で術後4コース 術前化療は2-3コース(1か月間隔) 免疫療法は術後6ヶ月間は毎月、その後は2カ月おきに2年間 |
group A: immunotherapy and chemotherapy
chemotherapy: CBDCA+GEM orCBDCA+PTX or CBDCA+PEM 4 courses every month 2 courses of Induction chemotherapy are applied for advanced cases Immunotherapy: every month for 6 courses and every 2 months for 2 years thereafter |
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介入2/Interventions/Control_2 | B 群 化学療法
化学療法はCBDCAを含む2剤併用で術後4コース 術前化療は2-3コース(1か月間隔) |
group B chemotherapy
chemotherapy: CBDCA+GEM orCBDCA+PTX or CBDCA+PEM 4 courses every month 2-3 courses of Induction chemotherapy are applied for advanced cases |
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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 |
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年齢(上限)/Age-upper limit |
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性別/Gender | 男女両方/Male and Female | ||||
選択基準/Key inclusion criteria | 1) 組織型・・・組織的に証明された非小細胞肺癌切除例
2) 病期 ・・・stage IIA 以上)でが んの遺残がないと判断されるもの 3) PS ・・・0または1 4) 所属リンパ節の培養で3X109(30億)個/month以上の細胞が得られる 5) 術後2ヶ月以内に治療開始ができる 6) 主要臓器の機能が保たれているもの WBC 3000/mm3以上12,000/mm3 以下 Plt 100,000/mm3 以上 Hb 8.0g/dl 以上 総ビリルビン 2.0mg/dl以下 AST,ALT 100IU/L 以下 血清クレアチニン 1.2mg/dl 以下 9) 患者本人から文書によるのインフォームトコンセントが得られたもの |
1)surgically resected primary non-small cell lung cancer patients
2) stage IIA -IV with no residual cancer after surgery 3) PS=0 or 1 4)more than 3X109(3 billion) activated killer cells are available from regional lymoh nodes for one course of immunotherapy 5) postsurgial treatment can be started within 2 months after surgery 6)chief organ functions are preserved 12000mm3 > WBC> 3000/mm3 Plt >100,000/mm3 Hb> 8.0g/dl TBil<2mg/dl AST,ALT <100IU/L Creatinin <1.2mg/dl 9)written informed consent are obtained |
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除外基準/Key exclusion criteria | 1 活動性の重複がんがない
2 感染症(HIV,HBS,HCV)がない 3 小細胞がん(combined は除く) |
1 with other active cancer
2 with viral infection (HIV,HBS,HCV) 3 small cell lung cancer( combied SCLC are included for the study) |
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目標参加者数/Target sample size | 160 |
責任研究者/Research contact person | ||||||||||||||
責任研究者/Name of lead principal investigator |
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所属組織/Organization | 千葉県がんセンター | Chiba Cancer Center | ||||||||||||
所属部署/Division name | 呼吸器科 | Division of thoaracic diseases | ||||||||||||
郵便番号/Zip code | ||||||||||||||
住所/Address | 〒260-8717 千葉市中央区仁戸名町666-2 | 666-2 Nitona-cho, Chu-O-ku ,Chiba city Chiba | ||||||||||||
電話/TEL | 043-264-5431 | |||||||||||||
Email/Email | h.kimura@chiba-saiseikai.com |
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 |
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組織名/Organization | 千葉県がんセンター | Chiba Cancer Center | ||||||||||||
部署名/Division name | 呼吸器科 | DIvision of Thoracic Diseases | ||||||||||||
郵便番号/Zip code | ||||||||||||||
住所/Address | 〒260-8717 千葉市中央区仁戸名町666-2 | 666-2 Nitona-cho, Chu-o-ku ,Chiba City,Chiba | ||||||||||||
電話/TEL | 043-264-5431 | |||||||||||||
試験のホームページURL/Homepage URL | ||||||||||||||
Email/Email | hkimura@chiba-cc.jp |
実施責任組織/Sponsor | ||
機関名/Institute | その他 | Chiba Cancer Center |
機関名/Institute (機関選択不可の場合) |
千葉県がんセンター | |
部署名/Department |
研究費提供組織/Funding Source | ||
機関名/Organization | その他 | Chiba Cancer Center |
機関名/Organization (機関選択不可の場合) |
千葉県がんセンター | |
組織名/Division | ||
組織の区分/Category of Funding Organization | 地方自治体/Local Government | |
研究費拠出国/Nationality of Funding Organization | なし | None |
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 | ||
住所/Address | ||
電話/Tel | ||
Email/Email |
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 |
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関連情報/Related information | ||
プロトコル掲載URL/URL releasing protocol | ||
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 | ||
組み入れ参加者数/Number of participants that the trial has enrolled | ||
主な結果/Results | Abstract
Purpose We conducted a phase III randomized controlled trial (RCT) to investigate the efficacy of postsurgical adjuvant immunotherapy combined with chemotherapy. The immunotherapy targets were residual micrometastases and clones resistant to chemotherapy. Patients and methods Between April 2007 and July 2012, 103 postsurgical non-small cell lung cancer patients were randomly assigned to receive either chemo-immunotherapy (group A) or chemotherapy (group B). The immunotherapy consisted of the adoptive transfer of autologous activated killer T cells and dendritic cells obtained from the lung cancer patients’ own regional lymph nodes. Results The 2-year overall survival rates in groups A and B were 93.4 and 66.0 %, and the 5-year rates were 81.4 and 48.3 %, respectively. The differences were statistically significantly better in group A. The hazard ratio (HR) was0.229 (p = 0.0013). The 2- and 5-year recurrence-free survival rates were 68.5, 41.4 and 56.8, 26.2 % in groups A and B, respectively. Those differences were also statistically significant (log-rank test p = 0.0020). The HR was 0.423 (p = 0.0027) in favor of group A. As for adverse reactions to immunotherapy, of a total of 762 courses, 52 (6.8 %) were accompanied with chills and shivering, and 47 (6.2 %), with fever (>38 °C). Conclusions Immunotherapy has the potential to improve the postsurgical prognosis of lung cancer patients, but a large-scale multi-institutional RCT is awaited for further confirmation of this study. |
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主な結果入力日/Results date posted | ||
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 | ||
参加者の流れ/Participant flow | ||
有害事象/Adverse events | ||
評価項目/Outcome measures | ||
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 | 限定募集中/Enrolling by invitation | |||||||
プロトコル確定日/Date of protocol fixation |
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倫理委員会による承認日/Date of IRB | ||||||||
登録・組入れ開始(予定)日/Anticipated trial start date |
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フォロー終了(予定)日/Last follow-up date |
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入力終了(予定)日/Date of closure to data entry |
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データ固定(予定)日/Date trial data considered complete |
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解析終了(予定)日/Date analysis concluded |
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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 |
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最終更新日/Last modified on |
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閲覧ページへのリンク/Link to view the page | |
URL(日本語) | https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000008887 |
URL(英語) | https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008887 |
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 |