Postoperative Radiotherapy for Patients With IIIA (N2) Non-small Cell Lung Cancer

NCT00880971 | Completed Phase 3 DMC

• 1 other identifier: CH-L-015
• Study Type: interventional
• Target: 394
• Locations: 1 country
• Sites: 1

Brief Summary

Several important international randomized trials have shown that postoperative chemotherapy contributed to the improvement on 5 year survival rate by about 4% for patients with non-small cell lung cancer (NSCLC) after complete resection. But the overall survival rate was relatively low and the local recurrence was still the dominant failure pattern for stage IIIA (N2) disease even these patients received the postoperative chemotherapy. Several meta-analyses have shown that postoperative radiotherapy (PORT) has no effect on the survival improvement for patients with NSCLC after complete resection. However, sub-group analysis based on the same dataset of these meta-analyses showed that the PORT with conventional radiotherapy might be beneficial for stage IIIA (N2) disease. The 3D conform radiotherapy (3D-CRT) and intensity modified radiotherapy (IMRT) can increase the radiation dose to the target volume while decreasing the dose to risk organs comparing with the conventional radiotherapy. So it is expected that PORT using 3D-CRT or IMRT after postoperative chemotherapy will improve the local control and survival for stage IIIA (N2) NSCLC. Here, the investigators designed a phase III randomized trial to compare the 3-year disease free survival (DFS) and overall survival (OS) rates in patients with completely resected stage IIIA (N2) NSCLC who receive adjuvant chemotherapy alone or adjuvant chemotherapy plus PORT.

Conditions

Thoracic Neoplasms; Non-small Cell Lung Cancer

Keywords

Lung; Carcinoma; radiotherapy; Surgery

Outcome Measures

Primary Outcomes (1)

• DFS

  Disease free survival measures in months.

  3 years

Secondary Outcomes (5)

• OS

  3 years

• LRFS

  3 years

• DMFS

  3 years

• Failure Patterns

  3 years

• Toxicity of thoracic radiotherapy

  6 months

Study Arms (2)

PORT

EXPERIMENTAL

Patients undergo thoracic radiotherapy using 3D-CRT or IMRT (50 Gy, 2 Gy once daily over 5 weeks) after postoperative chemotherapy.

Radiation: Postoperative 3D-CRT or IMRT

Non-PORT

NO INTERVENTION

Patients undergo postoperative chemotherapy.

Interventions

Postoperative 3D-CRT or IMRT RADIATION

Postoperative radiotherapy using 3D-CRT or IMRT techniques, 2 Gy per fraction, total 25 fractions (50Gy) over 5 weeks.

Also known as: Postoperative radiotherapy

PORT

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Completely resected disease by lobectomy, bilobectomy. Complete dissection of lymph nodes at levels 4, 7, and 10 in case of right-sided thoracotomy and at levels 4 (if accessible), 5, 6, 7, and 10 in case of left-sided thoracotomy.
• Histologically N2 disease after surgery. Negative margins
• Has undergone chemotherapy of four cycles of platinum-based doublet regimen and no recurrence and metastasis

You may not qualify if:

• Pregnant or nursing
• 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

Sponsors & Collaborators

• Chinese Academy of Medical Sciences: lead

Study Sites (1)

Cancer Hosiptal, Chinese Academy of Medical Sciences

Beijing, 100021, China

Location

Related Publications (13)

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  PMID: 7580546 BACKGROUND

• 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.

  PMID: 9690404 BACKGROUND

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  PMID: 11071672 BACKGROUND

• 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.

  PMID: 16769986 BACKGROUND

• 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.

  PMID: 11579111 BACKGROUND

• 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.

  PMID: 18413349 BACKGROUND

• 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.

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  PMID: 18809614 BACKGROUND

• 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.

  PMID: 17538170 BACKGROUND

• 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.

  PMID: 16000606 BACKGROUND

• 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.

  PMID: 41146922 DERIVED

• 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.

  PMID: 34165501 DERIVED

• 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.

  PMID: 31400325 DERIVED

MeSH Terms

Conditions

Thoracic Neoplasms; Carcinoma, Non-Small-Cell Lung; Carcinoma

Interventions

Radiotherapy, Intensity-Modulated

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Lung Diseases; Respiratory Tract Diseases; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Radiotherapy, Conformal; Radiotherapy, Computer-Assisted; Radiotherapy; Therapeutics

Study Officials

• Luhua Wang, MD

  Cancer Hosiptal, Chinese Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chairman of Thoracic Group, Clinical Professor, Radiation Oncology Department, Cancer Hospital&Institute

Study Record Dates

• First Submitted: April 13, 2009
• First Posted: April 14, 2009
• Study Start: February 18, 2009
• Primary Completion: December 31, 2019
• Study Completion: February 29, 2020
• Last Updated: October 5, 2020

Record last verified: 2020-10

Locations

CN (1)