Adjuvant Chemotherapy for High Risk Stage I Lung Adenocarcinoma

Summary

This is a clinical trial from Eastern Cooperative Thoracic Oncology Project (ECTOP), numbered as ECTOP-1004. Solid subtype, micropapillary subtype, vascular involvement, pleural involvement and low differentiation are high risk factors of post-operative recurrence for early-stage lung adenocarcinoma patients. The purpose of this clinical trial is to determine whether the widely used adjuvant chemotherapy strategy cisplatin/ pemetrexed is more effective than no further treatment for Stage pI lung adenocarcinoma patients with high post-operative recurrence risk - in terms of no dose related toxicities, premature treatment withdrawal or death.

Timeline

Start

2018-01-01

Primary completion

2024-01-01

Completion

2025-12-31

Publications

• Background Chen W, Zheng R, Baade PD, Zhang S, Zeng H, Bray F, Jemal A, Yu XQ, He J. Cancer statistics in China, 2015. CA Cancer J Clin. 2016 Mar-Apr;66(2):115-32. doi: 10.3322/caac.21338. Epub 2016 Jan 25.
• Background Kelsey CR, Marks LB, Hollis D, Hubbs JL, Ready NE, D'Amico TA, Boyd JA. Local recurrence after surgery for early stage lung cancer: an 11-year experience with 975 patients. Cancer. 2009 Nov 15;115(22):5218-27. doi: 10.1002/cncr.24625.
• Background Zhang Y, Li J, Wang R, Li Y, Pan Y, Cai D, Hu H, Li H, Ye T, Luo X, Zhang Y, Li B, Shen L, Sun Y, Chen H. The prognostic and predictive value of solid subtype in invasive lung adenocarcinoma. Sci Rep. 2014 Nov 24;4:7163. doi: 10.1038/srep07163.
• Background Zhang Y, Wang R, Cai D, Li Y, Pan Y, Hu H, Wang L, Li H, Ye T, Luo X, Zhang Y, Li B, Shen L, Sun Y, Chen H. A comprehensive investigation of molecular features and prognosis of lung adenocarcinoma with micropapillary component. J Thorac Oncol. 2014 Dec;9(12):1772-8. doi: 10.1097/JTO.0000000000000341.
• Background Yoshizawa A, Motoi N, Riely GJ, Sima CS, Gerald WL, Kris MG, Park BJ, Rusch VW, Travis WD. Impact of proposed IASLC/ATS/ERS classification of lung adenocarcinoma: prognostic subgroups and implications for further revision of staging based on analysis of 514 stage I cases. Mod Pathol. 2011 May;24(5):653-64. doi: 10.1038/modpathol.2010.232. Epub 2011 Jan 21.
• Background Shimada Y, Saji H, Yoshida K, Kakihana M, Honda H, Nomura M, Usuda J, Kajiwara N, Ohira T, Ikeda N. Pathological vascular invasion and tumor differentiation predict cancer recurrence in stage IA non-small-cell lung cancer after complete surgical resection. J Thorac Oncol. 2012 Aug;7(8):1263-70. doi: 10.1097/JTO.0b013e31825cca6e.
• Background Al-Alao BS, Gately K, Nicholson S, McGovern E, Young VK, O'Byrne KJ. Prognostic impact of vascular and lymphovascular invasion in early lung cancer. Asian Cardiovasc Thorac Ann. 2014 Jan;22(1):55-64. doi: 10.1177/0218492313478431. Epub 2013 Sep 4.
• Background Chen YY, Huang TW, Tsai WC, Lin LF, Cheng JB, Lee SC, Chang H. Lymphovascular space invasion and tumor differentiation are predictors for postoperative recurrence in patients with pathological stage I nonsmall cell lung cancer. J Chin Med Assoc. 2014 Aug;77(8):416-21. doi: 10.1016/j.jcma.2014.05.008. Epub 2014 Jul 12.
• Background Park C, Lee IJ, Jang SH, Lee JW. Factors affecting tumor recurrence after curative surgery for NSCLC: impacts of lymphovascular invasion on early tumor recurrence. J Thorac Dis. 2014 Oct;6(10):1420-8. doi: 10.3978/j.issn.2072-1439.2014.09.31.
• Background Yano M, Sasaki H, Moriyama S, Kawano O, Hikosaka Y, Fujii Y. Prognostic factors of pathologic stage IB non-small cell lung cancer. Ann Thorac Cardiovasc Surg. 2011;17(1):58-62. doi: 10.5761/atcs.cr.09.01481.
• Background Huang H, Wang T, Hu B, Pan C. Visceral pleural invasion remains a size-independent prognostic factor in stage I non-small cell lung cancer. Ann Thorac Surg. 2015 Apr;99(4):1130-9. doi: 10.1016/j.athoracsur.2014.11.052. Epub 2015 Feb 20.
• Background Jiang L, Liang W, Shen J, Chen X, Shi X, He J, Yang C, He J. The impact of visceral pleural invasion in node-negative non-small cell lung cancer: a systematic review and meta-analysis. Chest. 2015 Oct;148(4):903-911. doi: 10.1378/chest.14-2765.
• Background Butts CA, Ding K, Seymour L, Twumasi-Ankrah P, Graham B, Gandara D, Johnson DH, Kesler KA, Green M, Vincent M, Cormier Y, Goss G, Findlay B, Johnston M, Tsao MS, Shepherd FA. Randomized phase III trial of vinorelbine plus cisplatin compared with observation in completely resected stage IB and II non-small-cell lung cancer: updated survival analysis of JBR-10. J Clin Oncol. 2010 Jan 1;28(1):29-34. doi: 10.1200/JCO.2009.24.0333. Epub 2009 Nov 23.
• Background Strauss GM, Herndon JE 2nd, Maddaus MA, Johnstone DW, Johnson EA, Harpole DH, Gillenwater HH, Watson DM, Sugarbaker DJ, Schilsky RL, Vokes EE, Green MR. Adjuvant paclitaxel plus carboplatin compared with observation in stage IB non-small-cell lung cancer: CALGB 9633 with the Cancer and Leukemia Group B, Radiation Therapy Oncology Group, and North Central Cancer Treatment Group Study Groups. J Clin Oncol. 2008 Nov 1;26(31):5043-51. doi: 10.1200/JCO.2008.16.4855. Epub 2008 Sep 22.
• Background Luo J, Huang Q, Wang R, Han B, Zhang J, Zhao H, Fang W, Luo Q, Yang J, Yang Y, Zhu L, Chen T, Cheng X, Wang Y, Zheng J, Wu H, Xia W, Chen H. Prognostic and predictive value of the novel classification of lung adenocarcinoma in patients with stage IB. J Cancer Res Clin Oncol. 2016 Sep;142(9):2031-40. doi: 10.1007/s00432-016-2192-6. Epub 2016 Jul 5.
• Background Tsao MS, Marguet S, Le Teuff G, Lantuejoul S, Shepherd FA, Seymour L, Kratzke R, Graziano SL, Popper HH, Rosell R, Douillard JY, Le-Chevalier T, Pignon JP, Soria JC, Brambilla EM. Subtype Classification of Lung Adenocarcinoma Predicts Benefit From Adjuvant Chemotherapy in Patients Undergoing Complete Resection. J Clin Oncol. 2015 Oct 20;33(30):3439-46. doi: 10.1200/JCO.2014.58.8335. Epub 2015 Apr 27.
• Background Liu CH, Peng YJ, Wang HH, Chen YC, Tsai CL, Chian CF, Huang TW. Heterogeneous prognosis and adjuvant chemotherapy in pathological stage I non-small cell lung cancer patients. Thorac Cancer. 2015 Sep;6(5):620-8. doi: 10.1111/1759-7714.12233. Epub 2015 Feb 27.
• Background Park SY, Lee JG, Kim J, Byun GE, Bae MK, Lee CY, Kim DJ, Chung KY. Efficacy of platinum-based adjuvant chemotherapy in T2aN0 stage IB non-small cell lung cancer. J Cardiothorac Surg. 2013 Jun 11;8:151. doi: 10.1186/1749-8090-8-151.
• Background Tsuchiya T, Akamine S, Muraoka M, Kamohara R, Tsuji K, Urabe S, Honda S, Yamasaki N. Stage IA non-small cell lung cancer: vessel invasion is a poor prognostic factor and a new target of adjuvant chemotherapy. Lung Cancer. 2007 Jun;56(3):341-8. doi: 10.1016/j.lungcan.2007.01.019. Epub 2007 Mar 9.
• Background Zhang H, Lu C, Lu Y, Yu B, Lv F, Zhu Z. The predictive and prognostic values of factors associated with visceral pleural involvement in resected lung adenocarcinomas. Onco Targets Ther. 2016 Apr 20;9:2337-48. doi: 10.2147/OTT.S100965. eCollection 2016.
• Background Aaronson NK, Ahmedzai S, Bergman B, Bullinger M, Cull A, Duez NJ, Filiberti A, Flechtner H, Fleishman SB, de Haes JC, et al. The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst. 1993 Mar 3;85(5):365-76. doi: 10.1093/jnci/85.5.365.

Drugs

Indications