AzTrials
AzTrials

Thoracic NeoplasmsPhase 3NCT00880971

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

A Phase 3 study testing Postoperative 3D-CRT or IMRT in people with Thoracic Neoplasms and Non-small Cell Lung Cancer, run by Chinese Academy of Medical Sciences at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 years
What is being tested?
Postoperative 3D-CRT or IMRT
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
394 participants
Where
1 siteChina
Study dates
18 Feb 2009to 29 Feb 2020
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

China1 site

  • Cancer Hosiptal, Chinese Academy of Medical Sciences

    Beijing, 100021

Other trials in China

About this study

Official title: Post-Operative Radiation Therapy for Patients With pⅢA-N2 Non-Small Cell Lung Cancer After Complete Resection and Adjuvant Chemotherapy: A Prospective Randomized Phase Ⅲ Study

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.

Read the detailed description

OBJECTIVES:

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.

Being tested
Postoperative 3D-CRT or IMRT
Keywords
Lung, Carcinoma, radiotherapy, Surgery
Medical subject headings
Thoracic Neoplasms, Carcinoma, Non-Small-Cell Lung, Carcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Postoperative 3D-CRT or IMRTRadiation

    Also called Postoperative radiotherapy

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

Study groups in NCT00880971
Study groupRoleWhat they receive
PORTExperimentalPatients undergo thoracic radiotherapy using 3D-CRT or IMRT (50 Gy, 2 Gy once daily over 5 weeks) after postoperative chemotherapy.
Receives: Radiation: Postoperative 3D-CRT or IMRT
Non-PORTNo interventionPatients undergo postoperative chemotherapy.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. DFS

    Disease free survival measures in months.

    Measured: 3 years

Secondary outcomes (5)

  1. OS

    Overall survival measures in months.

    Measured: 3 years

  2. LRFS

    Loco-regional recurrence free survival measures in months.

    Measured: 3 years

  3. DMFS

    Distant metastasis free survival measures in months.

    Measured: 3 years

  4. Failure Patterns

    Loco-regional recurrence (LR) and Distant metastasis (DM)

    Measured: 3 years

  5. Toxicity of thoracic radiotherapy

    CTC AE 3.0 is used to evaluate the toxicities, including radiation esophagitis (RE) and pneumonitis (RP).

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Apr 2009 (estimated)
  2. Study start18 Feb 2009
  3. Primary completion31 Dec 2019
  4. Study completion29 Feb 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
394 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00880971
Sponsor's protocol ID
CH-L-015
Status last verified
Oct 2020
First submitted
13 Apr 2009
Last updated
5 Oct 2020
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 7580546

  • 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.

    PubMed 9690404

  • 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.

    PubMed 11071672

  • 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.

    PubMed 16769986

  • 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.

    PubMed 11579111

  • 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.

    PubMed 18413349

  • 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.

    PubMed 18439766

  • 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.

    PubMed 18809614

  • 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.

    PubMed 17538170

  • 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.

    PubMed 16000606

  • 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.

    PubMed 41146922

  • 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.

    PubMed 34165501

  • 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.

    PubMed 31400325

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Postoperative 3D-CRT or IMRT in people with Thoracic Neoplasms and Non-small Cell Lung Cancer, run by Chinese Academy of Medical Sciences at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

DFS (time frame: 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00880971, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2020.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in