医療関係者の方へ 診療科案内

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肺・胸部研究

呼吸器外科部門では、患者さんを対象とした医学研究（臨床研究）を通じて、肺がんを中心とした呼吸器疾患の病態解明、治療法の確立、予後の改善に貢献することを目指しています。特に、新たな治療法や薬剤の効果と安全性を評価する「臨床試験」にも積極的に取り組んでおり、国内外の研究グループと連携しながら、多くの研究を推進しています。

主な研究活動

当部門では、JCOG（日本臨床腫瘍研究グループ）、WJOG（西日本がん研究機構）、LC-SCRUM-Asia、肺癌登録合同委員会などの研究グループと協力し、多施設共同研究を数多く実施しています。また、企業との共同研究や独自の研究にも積極的に参画しており、幅広い視点から肺がんの治療に関する知見を深めています。

研究一覧

JCOG関連研究

  • JCOG0802/WJOG4607L：肺野末梢小型非小細胞肺癌に対する肺葉切除と縮小切除（区域切除）の第III相試験
  • JCOG1211：胸部薄切CT 所見に基づくすりガラス影優位のcT1N0 肺癌に対する区域切除の非ランダム化検証的試験
  • JCOG1708：特発性肺線維症（IPF）合併臨床病期 I 期非小細胞肺癌に対する肺縮小手術に 関するランダム化比較第 III 相試験（研究事務局：津谷）
  • JCOG 1906：胸部薄切CT所見に基づく早期肺癌に対する経過観察の単群検証的試験
  • JCOG1909：肺葉切除高リスク臨床病期IA 期非小細胞肺癌に対する区域切除と楔状切除のランダム化比較試験（研究事務局：津谷）
  • JCOG1916：病理学的 N2 非小細胞肺癌に対する術後放射線治療に関するランダム化比較第 III 相試験
  • JCOG2012：病理病期 II-IIIA 期非小細胞肺癌に対する術後サーベイランスに関する ランダム化比較試験
  • JCOG2108：非小細胞肺癌術後オリゴ再発に対する全身治療後の維持療法と局所療法を比較するランダム化比較第III相試験
  • JCOG2109：80歳以上の高齢者肺野末梢小型非小細胞肺癌における区域切除vs.楔状切除のランダム化比較試験
  • JCOG2217：胸部薄切CT上すりガラス成分を伴う充実成分優位な非小細胞肺癌（＞2-3 cm）に対する肺葉切除と区域切除のランダム化比較試験
  • JCOG2208A：cIA期肺癌を対象として薄切CTと臨床所見から人工知能で病理・予後予測アルゴリズムを探索的に構築する統合解析研究
  • JCOG2317：切除可能な臨床病期II-III期非小細胞肺癌に対する術前療法後手術と手術先行療法に関するランダム化比較第III相試験（研究代表者：津谷、研究事務局：濵田）
  • JCOG-バイオバンク・ジャパン連携バイオバンク

WJOG関連研究

  • WJOG16622L：非小細胞肺癌手術例における全ゲノム解析を用いたバイオマーカー研究
  • WJOG16923L：臨床病期IA3期の肺野末梢充実型非小細胞肺癌に対する肺葉切除と区域切除のランダム化比較第Ⅲ相試験（研究代表者：津谷、研究事務局：濵田）
  • WJOG17023L：EGFR 遺伝子変異陽性非小細胞肺癌完全切除例の前向き観察研究
  • WJOG17123L：病理病期 IA2-IIA 期EGFR 遺伝子変異陽性非小細胞肺癌における術後補助療法の実態を調査する多施設共同前向き観察研究

LC-SCRUM-Asia

  • LC-SCRUM-Asia：アジア人の非小細胞肺癌における 個別化医療の確立を目指した、遺伝子スクリーニングとモニタリングのための多施設共同前向き観察研究
  • LC-SCRUM-Advantage/MRD：肺癌における周術期個別化医療の確立を目指した遺伝子スクリーニングと微小残存病変のモニタリングのための多施設共同前向き観察研究

肺癌登録合同委員会

  • 肺癌登録合同委員会第10事業：2017年に外科治療を施行された肺癌症例のデータベース研究
  • 肺癌登録合同委員会第11事業：2021年に外科治療を施行された肺癌症例のデータベース研究

その他共同研究

  • CReGYT-01 EGFR study：肺腺がん手術後症例におけるEGFR検査結果に基づく再発及び予後に関する多施設共同後ろ向き観察研究
  • CReGYT-02 sublobar study：非小細胞肺癌に対する縮小手術後症例における再発及び長期予後に関する多施設共同後ろ向き観察研究
  • CReGYT-03 ALK study：肺腺癌手術症例におけるALK融合遺伝子に関する疫学ならびに再発・予後を調査する多機関共同後ろ向き観察研究（研究代表者：津谷、研究事務局：濵田）
  • CReGYT-04 Neo-Venus study：非小細胞肺癌における術前化学免疫療法の安全性・有効性に関する多施設共同後ろ向き観察研究
  • CReGYT-05 ICI-Salvage study：原発性肺癌に対する免疫療法後サルベージ手術の有効性・安全性を検討する多施設後向き研究観察研究
  • NeoFACT：切除可能非小細胞肺癌における術前化学免疫療法の実態を調査する多施設共同観察研究
  • NEJ034：特発性肺線維症（IPF）合併非小細胞肺癌に対する周術期ピルフェニドン療法の術後急性増悪抑制効果に関する第Ⅲ相試験
  • Pvstudy：左側肺切除術後肺静脈断端血栓の発生予防におけるヘパリン投与の有効性に関する多施設共同ランダム化比較試験
  • NINJA P-2 study：特発性肺線維症合併非小細胞肺癌根治切除後患者に対するニンテダニブ投与の忍容性に関する第二相単群介入試験
  • 局所進行非小細胞肺癌に対する化学放射線療法を受けた患者の後ろ向き研究（HOPE-005/CRIMSON）に附随する画像評価の検討
  • 麻酔方法が肺癌術後予後に与える影響を調査するための多施設共同後ろ向き観察研究
  • 肺癌患者の術式選択と他病死リスクに関する多施設共同後ろ向き観察研究－肺切除と他病死リスク研究－
  • 呼吸器外科学会：肺癌免疫チェックポイント阻害剤治療後サルベージ手術の有効性と安全性を検討する多施設共同後ろ向き臨床研究
  • 胸部腫瘍に対する画像診断AIを用いた診断技術の改善に関する後ろ向き非介入研究

企業・機関との共同研究

  • J-CURE：切除後の非小細胞肺癌に対するアテゾリズマブ術後補助療法の多機関共同前向き観察研究
  • NivoLuminate：切除可能な非小細胞肺がんを対象 とした 術前補助療法としてのニボルマブおよび
  • 外科切除症例におけるGuardant Revealアッセイを用いた微小残存病変の検出と経時的な再発モニタリング

治験

新薬の承認を目的として行われる「治験」にも力を入れており、GCP（Good Clinical Practice）に基づいた厳格な基準のもとで実施しています。

現在実施中の治験

  • 肺がんに関する治験：11件（うち登録中：5件）
  • 悪性胸膜中皮腫に関する治験：2件（登録中：2件）

このように、呼吸器外科部門では臨床研究を通じて、医学の進歩と患者さんの利益に貢献すべく、日々取り組んでおります。

2011年以降発表の英文論文

  1. Handa Y, Tsutani Y, Ito M, Miyata Y, Mukaida H, Kaneko M, Takeshima Y, Okada M. Clinical Behavior of Combined Versus Pure High-Grade Neuroendocrine Carcinoma. Clin Lung Cancer. 2022 Jan;23(1):e9-e16.e1.
  2. Kagimoto A, Tsutani Y, Mimae T, Miyata Y, Okada M. Segmentectomy versus lobectomy for solid predominant cN0 lung cancer: analysis using visual evaluation of positron emission tomography. Eur J Cardiothorac Surg. 2022 Jan 24;61(2):279-286.
  3. Suda K, Ohara S, Fujino T, Hamada A, Chiba M, Shimoji M, Takemoto T, Soh J, Mitsudomi T. Frequent EGFR Mutations and Better Prognosis in Positron Emission Tomography-Negative, Solid-Type Lung Cancer. Clin Lung Cancer. 2022 Jan;23(1):e60-e68.
  4. Tada H, Mitsudomi T, Misumi T, Sugio K, Tsuboi M, Okamoto I, Iwamoto Y, Sakakura N, Sugawara S, Atagi S, Takahashi T, Hayashi H, Okada M, Inokawa H, Yoshioka H, Takahashi K, Higashiyama M, Yoshino I, Nakagawa K; West Japan Oncology Group. Randomized Phase III Study of Gefitinib Versus Cisplatin Plus Vinorelbine for Patients With Resected Stage II-IIIA Non-Small-Cell Lung Cancer With EGFR Mutation (IMPACT). J Clin Oncol. 2022 Jan 20;40(3):231-241
  5. Suzuki K, Watanabe SI, Wakabayashi M, Saji H, Aokage K, Moriya Y, Yoshino I, Tsuboi M, Nakamura S, Nakamura K, Mitsudomi T, Asamura H; West Japan Oncology Group and Japan Clinical Oncology Group. A single-arm study of sublobar resection for ground-glass opacity dominant peripheral lung cancer. J Thorac Cardiovasc Surg. 2022 Jan;163(1):289-301.e2.
  6. Basu Roy U, Baird AM, Ciupek A, Fox J, Manley E Jr, Norris Xx K, Scagliotti GV, Wakelee HA, Mitsudomi T, Clark RC, Arndt R, Hirsch FR, Bunn PA, Smeltzer MP. Impact of the Coronavirus Disease 2019 Pandemic on Global Lung Cancer Clinical Trials: Why It Matters to People With Lung Cancer. JTO Clin Res Rep. 2022 Feb;3(2):100269.
  7. Koga T, Suda K, Mitsudomi T. Utility of the Ba/F3 cell system for exploring on-target mechanisms of resistance to targeted therapies for lung cancer. Cancer Sci. 2022 Mar;113(3):815-827.
  8. Hamada A, Suda K, Fujino T, Nishino M, Ohara S, Koga T, Kabasawa T, Chiba M, Shimoji M, Endoh M, Takemoto T, Soh J, Yanagawa N, Shiono S, Mitsudomi T. Presence of a Ground-Glass Opacity Component Is the True Prognostic Determinant in Clinical Stage I NSCLC. JTO Clin Res Rep. 2022 Apr 6;3(5):100321.
  9. Hamada A, Oizumi H, Kato H, Suzuki J, Nakahashi K, Takamori S, Sho R, Sadahiro M. Outcome of thoracoscopic anatomical sublobar resection under 3-dimensional computed tomography simulation. Surg Endosc. 2022 Apr;36(4):2312-2320.
  10. Handa Y, Tsutani Y, Mimae T, Miyata Y, Ito H, Shimada Y, Nakayama H, Ikeda N, Okada M. Complex Segmentectomy for Hypermetabolic Clinical Stage IA Non-Small Cell Lung Cancer. Ann Thorac Surg. 2022 Apr;113(4):1317-1324.
  11. Oizumi S, Takamura K, Harada T, Tachihara M, Morikawa N, Honda R, Watanabe S, Asao T, Kunisaki M, Fukuhara T, Noro R, Kikuchi E, Tsutani Y, Tenma T, Kobayashi K, Dosaka-Akita H; North East Japan Study Group, Hokkaido Lung Cancer Clinical Study Group. Phase II study of carboplatin-paclitaxel alone or with bevacizumab in advanced sarcomatoid carcinoma of the lung: HOT1201/NEJ024. Int J Clin Oncol. 2022 Apr;27(4):676-683.
  12. Saji H, Okada M, Tsuboi M, Nakajima R, Suzuki K, Aokage K, Aoki T, Okami J, Yoshino I, Ito H, Okumura N, Yamaguchi M, Ikeda N, Wakabayashi M, Nakamura K, Fukuda H, Nakamura S, Mitsudomi T, Watanabe SI, Asamura H; West Japan Oncology Group and Japan Clinical Oncology Group. Segmentectomy versus lobectomy in small-sized peripheral non-small-cell lung cancer (JCOG0802/WJOG4607L): a multicentre, open-label, phase 3, randomised, controlled, non-inferiority trial. Lancet. 2022 Apr 23;399(10335):1607-1617.
  13. Fujino T, Suda K, Sakai K, Murakami I, Shimizu S, Ohara S, Koga T, Hamada A, Soh J, Nishio K, Mitsudomi T. Intra-tumor and Inter-tumor Heterogeneity in MET Exon 14 Skipping Mutations and Co-mutations in Pulmonary Pleomorphic Carcinomas. Clin Lung Cancer. 2022 May;23(3):e185-e195.
  14. Nakao S, Yamaguchi K, Iwamoto H, Kagimoto A, Mimae T, Tsutani Y, Miyata Y, Hamada H, Okada M, Hattori N. Role of Soluble Receptor for Advanced Glycation End Products in Postoperative Fibrotic Lung Injury. Ann Thorac Surg. 2022 May;113(5):1617-1623.
  15. Forde PM, Spicer J, Lu S, Provencio M, Mitsudomi T, Awad MM, Felip E, Broderick SR, Brahmer JR, Swanson SJ, Kerr K, Wang C, Ciuleanu TE, Saylors GB, Tanaka F, Ito H, Chen KN, Liberman M, Vokes EE, Taube JM, Dorange C, Cai J, Fiore J, Jarkowski A, Balli D, Sausen M, Pandya D, Calvet CY, Girard N; CheckMate 816 Investigators. Neoadjuvant Nivolumab plus Chemotherapy in Resectable Lung Cancer. N Engl J Med. 2022 May 26;386(21):1973-1985.
  16. Tsutani Y, Imai K, Ito H, Miyata Y, Ikeda N, Nakayama H, Okada M. Adjuvant Chemotherapy for High-risk Pathologic Stage I Non-Small Cell Lung Cancer. Ann Thorac Surg. 2022 May;113(5):1608-1616.
  17. Smeltzer MP, Scagliotti GV, Wakelee HA, Mitsudomi T, Roy UB, Clark RC, Arndt R, Pruett CD, Kelly KL, Ujhazy P, Johnson ML, Eralp Y, Barrios CH, Barlesi F, Hirsch FR, Bunn PA; International Association for the Study of Lung Cancer Coronavirus Disease 2019 and Clinical Trials Steering Committee. International Association for the Study of Lung Cancer Study of the Impact of Coronavirus Disease 2019 on International Lung Cancer Clinical Trials. J Thorac Oncol. 2022 May;17(5):651-660.
  18. Heymach JV, Mitsudomi T, Harpole D, Aperghis M, Jones S, Mann H, Fouad TM, Reck M. Design and Rationale for a Phase III, Double-Blind, Placebo-Controlled Study of Neoadjuvant Durvalumab + Chemotherapy Followed by Adjuvant Durvalumab for the Treatment of Patients With Resectable Stages II and III non-small-cell Lung Cancer: The AEGEAN Trial. Clin Lung Cancer. 2022 May;23(3):e247-e251.
  19. Mimae T, Miyata Y, Tsutani Y, Shimada Y, Ito H, Nakayama H, Ikeda N, Okada M. Role of ground-glass opacity in pure invasive and lepidic component in pure solid lung adenocarcinoma for predicting aggressiveness. JTCVS Open. 2022 May 2;11:300-316.
  20. Mimae T, Miyata Y, Kumada T, Handa Y, Tsutani Y, Okada M. Interstitial pneumonia and advanced age negatively influence postoperative pulmonary function. Interact Cardiovasc Thorac Surg. 2022 May 2;34(5):753-759.
  21. Kagimoto A, Tsutani Y, Mimae T, Miyata Y, Okada M. Segmentectomy versus wedge resection for radiological solid predominant and low metabolic non-small cell lung cancer. Interact Cardiovasc Thorac Surg. 2022 May 2;34(5):814-821.
  22. Pedraz-Valdunciel C, Giannoukakos S, Potie N, Giménez-Capitán A, Huang CY, Hackenberg M, Fernandez-Hilario A, Bracht J, Filipska M, Aldeguer E, Rodríguez S, Bivona TG, Warren S, Aguado C, Ito M, Aguilar-Hernández A, Molina-Vila MA, Rosell R. Digital multiplexed analysis of circular RNAs in FFPE and fresh non-small cell lung cancer specimens. Mol Oncol. 2022 Jun;16(12):2367-2383.
  23. Fujino T, Suda K, Koga T, Hamada A, Ohara S, Chiba M, Shimoji M, Takemoto T, Soh J, Mitsudomi T. Foretinib can overcome common on-target resistance mutations after capmatinib/tepotinib treatment in NSCLCs with MET exon 14 skipping mutation. J Hematol Oncol. 2022 Jun 11;15(1):79.
  24. Ito M, Miyata Y, Hirano S, Irisuna F, Kushitani K, Kai Y, Kishi N, Tsutani Y, Takeshima Y, Okada M. Sensitivity and optimal clinicopathological features for mutation-targeted liquid biopsy in pN0M0 EGFR-mutant lung adenocarcinoma. J Cancer Res Clin Oncol. 2022 Jun;148(6):1419-1428.
  25. Handa Y, Tsutani Y, Mimae T, Miyata Y, Shimada Y, Ito H, Nakayama H, Ikeda N, Okada M. A Multicenter Study of Complex Segmentectomy Versus Wedge Resection in Clinical Stage 0-IA Non-Small Cell Lung Cancer. Clin Lung Cancer. 2022 Jul;23(5):393-401.
  26. Kagimoto A, Tsutani Y, Shimada Y, Mimae T, Miyata Y, Ito H, Nakayama H, Ikeda N, Okada M. Oncological outcome of segmentectomy for early-stage non-small-cell lung cancer with invasive characteristics: a multicentre study. Eur J Cardiothorac Surg. 2022 Jul 11;62(2):ezac055.
  27. Rosell R, González-Cao M, Ito M, Jordan MM, Gómez-Vázquez JL, Chen JH, Aguilar A, Chaib I. Kisspeptins and norepinephrine regulate different G-protein-coupled receptor signaling pathways. Transl Lung Cancer Res. 2022 Aug;11(8):1517-1521.
  28. Kamigaichi A, Tsutani Y, Mimae T, Miyata Y, Shimada Y, Ito H, Nakayama H, Ikeda N, Okada M. The prognostic impact of the ground-glass opacity component in nearly pure-solid stage IA non-small-cell lung cancer. Eur J Cardiothorac Surg. 2022 Aug 3;62(3):ezac166.
  29. Johnson M, Garassino MC, Mok T, Mitsudomi T. Treatment strategies and outcomes for patients with EGFR-mutant non-small cell lung cancer resistant to EGFR tyrosine kinase inhibitors: Focus on novel therapies. Lung Cancer. 2022 Aug;170:41-51.
  30. Terai H, Soejima K, Shimokawa A, Horinouchi H, Shimizu J, Hase T, Kanemaru R, Watanabe K, Ninomiya K, Aragane N, Yanagitani N, Sakata Y, Seike M, Fujimoto D, Kasajima M, Kubo A, Kusumoto S, Oyamada Y, Fujiwara K, Mori M, Hashimoto M, Shingyoji M, Kodani M, Sakamoto J, Agatsuma T, Kashiwabara K, Inomata M, Tachihara M, Tanaka K, Hayashihara K, Koyama N, Matsui K, Minato K, Jingu D, Sakashita H, Hara S, Naito T, Okada A, Tanahashi M, Sato Y, Asano K, Takeda T, Nakazawa K, Harada T, Shibata K, Kato T, Miyaoka E, Yoshino I, Gemma A, Mitsudomi T. Real-World Data Analysis of Pembrolizumab Monotherapy for NSCLC Using Japanese Postmarketing All-Case Surveillance Data. JTO Clin Res Rep. 2022 Sep 1;3(11):100404.
  31. Mimae T, Miyata Y, Kumada T, Tsutani Y, Okada M. The intersegmental pulmonary vein is not always located on the intersegmental plane of the lung: Evaluation with 3-dimensional volume-rendering image reconstruction. JTCVS Tech. 2022 Sep 13;16:132-138.
  32. Haratake N, Shimokawa M, Seto T, Yoshioka H, Yamamoto N, Nakagawa K, Mitsudomi T. Survival benefit of using pemetrexed for EGFR mutation-positive advanced non-small-cell lung cancer in a randomized phase III study comparing gefitinib to cisplatin plus docetaxel (WJTOG3405). Int J Clin Oncol. 2022 Sep;27(9):1404-1412.
  33. Tsutani Y, Ito M, Shimada Y, Ito H, Ikeda N, Nakayama H, Okada M. The impact of epidermal growth factor receptor mutation status on adjuvant chemotherapy for patients with high-risk stage I lung adenocarcinoma. J Thorac Cardiovasc Surg. 2022 Nov;164(5):1306-1315.e4.
  34. Kagimoto A, Tsutani Y, Okada M. Segmentectomy for Spread Through Air Spaces-positive Lung Adenocarcinoma. Ann Thorac Surg. 2022 Nov;114(5):1989-1990.
  35. Kagimoto A, Tsutani Y, Shimada Y, Mimae T, Miyata Y, Ito H, Nakayama H, Ikeda N, Okada M. Segmentectomy for clinically early-stage primary squamous cell carcinoma of the lung. Thorac Cancer. 2022 Dec;13(24):3477-3485.
  36. Ueda D, Tsutani Y, Kamigaichi A, Kawamoto N, Tsubokawa N, Ito M, Mimae T, Miyata Y, Okada M. Impact of the amount of preoperative erector spinae muscle in stage I non-small-cell lung cancer. Eur J Cardiothorac Surg. 2022 Dec 2;63(1):ezac510.
  37. Rosell R, González-Cao M, Ito M, Santarpia M, Aguilar A, Codony-Servat J. The role of biomarkers in stage III non-small cell lung cancer. Expert Rev Respir Med. 2023 Jan-Jun;17(6):469-480.
  38. Hamada A, Kitajima K, Suda K, Koga T, Soh J, Kaida H, Ito K, Sekine T, Takegahara K, Daisaki H, Hashimoto M, Yoshida Y, Kabasawa T, Yamasaki T, Hirota S, Usuda J, Ishii K, Mitsudomi T. Prognostic role of preoperative fluorine-18 fluorodeoxyglucose-positron emission tomography/computed tomography with an image-based harmonization technique: A multicenter retrospective study. JTCVS Open. 2023 Feb 14:14:502-522.
  39. Kawamoto N, Tsutani Y, Kamigaichi A, Ohsawa M, Mimae T, Miyata Y, Okada M. Tumour location predicts occult N1 nodal metastasis in clinical stage I non-small-cell lung cancer. Eur J Cardiothorac Surg. 2023 Feb 3;63(2):ezac575.
  40. Kagimoto A, Tsutani Y, Kushitani K, Kambara T, Mimae T, Miyata Y, Takeshima Y, Okada M . Usefulness of serum S100A4 and positron-emission tomography on lung cancer accompanied by interstitial pneumonia. Thorac Cancer. 2023 Feb;14(4):381-388.
  41. Miura S, Nishio M, Akamatsu H, Goto Y, Hayashi H, Gemma A, Yoshino I, Misumi T, Hata A, Hataji O, Fujita K, Seike M, Yanagitani N, Nishino K, Hara S, Saito R, Mori M, Tsuda T, Iwasawa S, Nakagawa S, Mitsudomi T. Effectiveness and Safety of Atezolizumab Monotherapy in Previously Treated Japanese Patients With Unresectable Advanced or Recurrent NSCLC: A Multicenter, Prospective, Observational Study (J-TAIL). JTO Clin Res Rep. 2023 Feb 24;4(3):100484.
  42. Yoshimura A, Yamada T, Serizawa M, Uehara H, Tanimura K, Okuma Y, Fukuda A, Watanabe S, Nishioka N, Takeda T, Chihara Y, Takemoto S, Harada T, Hiranuma O, Shirai Y, Shukuya T, Nishiyama A, Goto Y, Shiotsu S, Kunimasa K, Morimoto K, Katayama Y, Suda K, Mitsudomi T, Yano S, Kenmotsu H, Takahashi T, Takayama K. High levels of AXL expression in untreated EGFR-mutated non-small cell lung cancer negatively impacts the use of osimertinib. Cancer Sci. 2023 Feb;114(2):606-618.
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肺・胸部

  • 一般の方へ 診療案内
  • 医局員募集
  • 近畿大学病院
  • NCD 外科系症例データベース（NCD）への登録を行っております。
  • 近畿大学病院外科専門研修プログラム(KINDAIプログラム)について

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