Postoperative Radiotherapy for Patients With IIIA (N2) Non-small Cell Lung Cancer
NCT ID: NCT00880971
Last Updated: 2020-10-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
394 participants
INTERVENTIONAL
2009-02-18
2020-02-29
Brief Summary
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Detailed Description
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Primary: To determine whether administering adjuvant chemotherapy (four cycles of platinum-based doublet regimen) plus PORT (50 Gy, 2 Gy once daily over 5 weeks) will improve 3-year DFS compared with adjuvant chemotherapy alone in patients with completely resected stage IIIA (N2) NSCLC.
Secondary: To compare treatment-related toxic effects, 3-year OS, failure-free survival, and the patterns of failure.
OUTLINE: Eligible patients were randomized equally, using simple randomization, to either PORT or observation group.
Arm I: Patients undergo PORT using 3D-CRT or IMRT (50 Gy, 2 Gy once daily over 5 weeks) after adjuvant chemotherapy.
Arm II: Patients undergo adjuvant chemotherapy.
After completion of study treatment, patients are followed every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter.
Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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PORT
Patients undergo thoracic radiotherapy using 3D-CRT or IMRT (50 Gy, 2 Gy once daily over 5 weeks) after postoperative chemotherapy.
Postoperative 3D-CRT or IMRT
Postoperative radiotherapy using 3D-CRT or IMRT techniques, 2 Gy per fraction, total 25 fractions (50Gy) over 5 weeks.
Non-PORT
Patients undergo postoperative chemotherapy.
No interventions assigned to this group
Interventions
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Postoperative 3D-CRT or IMRT
Postoperative radiotherapy using 3D-CRT or IMRT techniques, 2 Gy per fraction, total 25 fractions (50Gy) over 5 weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Histologically N2 disease after surgery. Negative margins
* Has undergone chemotherapy of four cycles of platinum-based doublet regimen and no recurrence and metastasis
Exclusion Criteria
* ECOG performance status \> 1
* Post-operative FEV\_1 \< 1 L (or \< 35% theoretical value, PO\_2 \< 70 mm Hg, and PCO\_2 \> 45 mm Hg)
* Severe cardiac disease within the past 6 months, including the following: Arrhythmia, Congestive heart failure, Infarction, Pacemaker
* Severe pulmonary disease within the past 6 months
* Other prior or concurrent neoplasm, except for basal cell carcinoma of the skin or carcinoma in situ of the cervix
* Severe or uncontrolled systemic disease
* Familial, social, geographic, or psychological conditions that would preclude study participation
18 Years
70 Years
ALL
No
Sponsors
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Chinese Academy of Medical Sciences
OTHER
Responsible Party
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Luhua Wang
Chairman of Thoracic Group, Clinical Professor, Radiation Oncology Department, Cancer Hospital&Institute
Principal Investigators
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Luhua Wang, MD
Role: PRINCIPAL_INVESTIGATOR
Cancer Hosiptal, Chinese Academy of Medical Sciences
Locations
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Cancer Hosiptal, Chinese Academy of Medical Sciences
Beijing, , China
Countries
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References
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Chemotherapy in non-small cell lung cancer: a meta-analysis using updated data on individual patients from 52 randomised clinical trials. Non-small Cell Lung Cancer Collaborative Group. BMJ. 1995 Oct 7;311(7010):899-909.
Postoperative radiotherapy in non-small-cell lung cancer: systematic review and meta-analysis of individual patient data from nine randomised controlled trials. PORT Meta-analysis Trialists Group. Lancet. 1998 Jul 25;352(9124):257-63.
Keller SM, Adak S, Wagner H, Herskovic A, Komaki R, Brooks BJ, Perry MC, Livingston RB, Johnson DH. A randomized trial of postoperative adjuvant therapy in patients with completely resected stage II or IIIA non-small-cell lung cancer. Eastern Cooperative Oncology Group. N Engl J Med. 2000 Oct 26;343(17):1217-22. doi: 10.1056/NEJM200010263431703.
Lally BE, Zelterman D, Colasanto JM, Haffty BG, Detterbeck FC, Wilson LD. Postoperative radiotherapy for stage II or III non-small-cell lung cancer using the surveillance, epidemiology, and end results database. J Clin Oncol. 2006 Jul 1;24(19):2998-3006. doi: 10.1200/JCO.2005.04.6110. Epub 2006 Jun 12.
Machtay M, Lee JH, Shrager JB, Kaiser LR, Glatstein E. Risk of death from intercurrent disease is not excessively increased by modern postoperative radiotherapy for high-risk resected non-small-cell lung carcinoma. J Clin Oncol. 2001 Oct 1;19(19):3912-7. doi: 10.1200/JCO.2001.19.19.3912.
Matsuguma H, Nakahara R, Ishikawa Y, Suzuki H, Inoue K, Katano S, Yokoi K. Postoperative radiotherapy for patients with completely resected pathological stage IIIA-N2 non-small cell lung cancer: focusing on an effect of the number of mediastinal lymph node stations involved. Interact Cardiovasc Thorac Surg. 2008 Aug;7(4):573-7. doi: 10.1510/icvts.2007.174342. Epub 2008 Apr 15.
Douillard JY, Rosell R, De Lena M, Riggi M, Hurteloup P, Mahe MA; Adjuvant Navelbine International Trialist Association. Impact of postoperative radiation therapy on survival in patients with complete resection and stage I, II, or IIIA non-small-cell lung cancer treated with adjuvant chemotherapy: the adjuvant Navelbine International Trialist Association (ANITA) Randomized Trial. Int J Radiat Oncol Biol Phys. 2008 Nov 1;72(3):695-701. doi: 10.1016/j.ijrobp.2008.01.044. Epub 2008 Apr 24.
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.
Ng R, Hasan B, Mittmann N, Florescu M, Shepherd FA, Ding K, Butts CA, Cormier Y, Darling G, Goss GD, Inculet R, Seymour L, Winton TL, Evans WK, Leighl NB; Working Group on Economic Analysis; Lung Disease Site Group; National Cancer Institute of Canada Clinical Trials Group. Economic analysis of NCIC CTG JBR.10: a randomized trial of adjuvant vinorelbine plus cisplatin compared with observation in early stage non-small-cell lung cancer--a report of the Working Group on Economic Analysis, and the Lung Disease Site Group, National Cancer Institute of Canada Clinical Trials Group. J Clin Oncol. 2007 Jun 1;25(16):2256-61. doi: 10.1200/JCO.2006.09.4342.
Dunant A, Pignon JP, Le Chevalier T. Adjuvant chemotherapy for non-small cell lung cancer: contribution of the International Adjuvant Lung Trial. Clin Cancer Res. 2005 Jul 1;11(13 Pt 2):5017s-5021s. doi: 10.1158/1078-0432.CCR-05-9006.
Men Y, Bao Y, Bi N, Zhou Z, Liang J, Lv J, Feng Q, Xiao Z, Wang Y, Li J, Wang J, Gao S, He J, Hui Z, Wang L. Long-term outcomes of postoperative radiotherapy for patients with pIIIA-N2 non-small-cell lung cancer after complete resection and adjuvant chemotherapy (PORT-C): a single-centre, randomized, phase 3 trial. EClinicalMedicine. 2025 Oct 16;89:103503. doi: 10.1016/j.eclinm.2025.103503. eCollection 2025 Nov.
Hui Z, Men Y, Hu C, Kang J, Sun X, Bi N, Zhou Z, Liang J, Lv J, Feng Q, Xiao Z, Chen D, Wang Y, Li J, Wang J, Gao S, Wang L, He J. Effect of Postoperative Radiotherapy for Patients With pIIIA-N2 Non-Small Cell Lung Cancer After Complete Resection and Adjuvant Chemotherapy: The Phase 3 PORT-C Randomized Clinical Trial. JAMA Oncol. 2021 Aug 1;7(8):1178-1185. doi: 10.1001/jamaoncol.2021.1910.
Wang J, Hui Z, Men Y, Kang J, Sun X, Deng L, Zhai Y, Wang W, Bi N, Liang J, Lv J, Zhou Z, Feng Q, Xiao Z, Chen D, Wang L, Zhao J. Systemic Inflammation-Immune Status Predicts Survival in Stage III-N2 Non-Small Cell Lung Cancer. Ann Thorac Surg. 2019 Dec;108(6):1701-1709. doi: 10.1016/j.athoracsur.2019.06.035. Epub 2019 Aug 7.
Other Identifiers
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CH-L-015
Identifier Type: -
Identifier Source: org_study_id
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