Comparison of Segmentectomy Versus Lobectomy for Non-small Cell Lung Cancer ≤ 2 cm in the Middle Third of the Lung Field

Surgery Clinical Trial

Official title:

Comparison of Segmentectomy Versus Lobectomy for Early-stage Non-small Cell Lung Cancer ≤ 2 cm in the Middle Third of the Lung Field: A Prospective and Multi-center RCT Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04944563
• Other study ID #: 2021-SR-164
• Status: Recruiting
• Phase: N/A
• Start date: July 20, 2021
• Est. completion date: December 1, 2029

Study information

• Verified date: April 2022
• Source: The First Affiliated Hospital with Nanjing Medical University
• Contact: Zhihua Li, M.D.
• Phone: +86-025-68303743
• Email: lizhihua_njmu[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study aims to investigate whether segmentectomy had non-inferiority long-term oncological effects (disease-free survival and overall survival) compared with lobectomy in the treatment of patients with early-stage non-small cell lung cancer ≤ 2 cm in the middle third of lung field.

Description:

Nowadays, the role of segment resection in the treatment of non-small cell lung cancer ≤ 2 cm in the outer third of the lung field has been evaluated in multiple studies. Recently, professor Hisao Asamura released the long-term results of the JCOG0802 project in AATS 2021. Segmentectomy had a higher 5-year overall survival (94.3% vs. 91.1%) than lobectomy (P < 0.001) for non-small cell lung cancer ≤ 2 cm (CTR > 0.5) in the outer third of the lung field. However, a substantial portion of lung nodules was not located in the outer third, but the middle third of the lung field. Whether segmentectomy has non-inferiority long-term oncological effects compared to lobectomy for early-stage non-small cell lung cancer ≤ 2 cm in the middle third of lung field remains unclear. This randomized controlled trial study aims to investigate whether segmentectomy has non-inferiority long-term oncological effects compared to lobectomy for early-stage non-small cell lung cancer ≤ 2 cm in the middle third of the lung field.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1120
• Est. completion date: December 1, 2029
• Est. primary completion date: December 1, 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Patient aged 18-75 years old;

2. 6 mm = tumor size = 20 mm;

3. 0.25 < CTR < 1;

4. Center of tumor located in the middle third of the lung field;

5. ECOG score of 0,1 or 2;

6. Lung function (FEV1 = 1 L and = 70%);

7. Both lung segmentectomy and lobectomy could achieve R0 resection;

8. No serious cardiopulmonary complications, and could withstand both lung segmentectomy and lobectomy;

9. No hilus pulmonis and mediastinal lymph node metastasis and no distant metastasis;

10. Single tumor nodule or the concomitant nodule < microinvasive tumor;

11. Written informed consent.

Exclusion Criteria:

1. The tumor nodule is located in right middle lobe;

2. A history of other malignancies in the last 5 years (exclusion of early-staged thyroid cancer);

3. Have received preoperative anti-tumor therapy, including prior chemotherapy, radiation therapy, target therapy and so on;

4. A serious mental illness;

5. Pregnant and lactating women;

6. Congestive heart failure, myocardial infarction, severe stenosis of coronary artery within recent 6 months;

7. With the history of cerebral infarction or cerebral hemorrhage within 6 months;

8. With the history of sustained systemic corticosteroid therapy within 1 month;

9. The predicted surgical margin is less than 2 cm or the maximum diameter of the tumor at the 3D-CTBA

10. Other unsuitable situations;

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Surgery

Intervention

Procedure:
• Segmentectomy
Patients receive segmentectomy
• Lobectomy
Patients receive lobectomy

Locations

Country	Name	City	State
China	Jiangsu Province Hospital, The First Affiliated Hospital of Nanjing Medical University	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital with Nanjing Medical University

Country where clinical trial is conducted

China, 

References & Publications (6)

Altorki NK, Wang X, Wigle D, Gu L, Darling G, Ashrafi AS, Landrenau R, Miller D, Liberman M, Jones DR, Keenan R, Conti M, Wright G, Veit LJ, Ramalingam SS, Kamel M, Pass HI, Mitchell JD, Stinchcombe T, Vokes E, Kohman LJ. Perioperative mortality and morbidity after sublobar versus lobar resection for early-stage non-small-cell lung cancer: post-hoc analysis of an international, randomised, phase 3 trial (CALGB/Alliance 140503). Lancet Respir Med. 2018 Dec;6(12):915-924. doi: 10.1016/S2213-2600(18)30411-9. Epub 2018 Nov 12. — View Citation

Nakamura K, Saji H, Nakajima R, Okada M, Asamura H, Shibata T, Nakamura S, Tada H, Tsuboi M. A phase III randomized trial of lobectomy versus limited resection for small-sized peripheral non-small cell lung cancer (JCOG0802/WJOG4607L). Jpn J Clin Oncol. 2010 Mar;40(3):271-4. doi: 10.1093/jjco/hyp156. Epub 2009 Nov 22. — View Citation

Suzuki K, Saji H, Aokage K, Watanabe SI, Okada M, Mizusawa J, Nakajima R, Tsuboi M, Nakamura S, Nakamura K, Mitsudomi T, Asamura H; West Japan Oncology Group; Japan Clinical Oncology Group. Comparison of pulmonary segmentectomy and lobectomy: Safety results of a randomized trial. J Thorac Cardiovasc Surg. 2019 Sep;158(3):895-907. doi: 10.1016/j.jtcvs.2019.03.090. Epub 2019 Apr 9. — View Citation

Tsutani Y, Miyata Y, Nakayama H, Okumura S, Adachi S, Yoshimura M, Okada M. Appropriate sublobar resection choice for ground glass opacity-dominant clinical stage IA lung adenocarcinoma: wedge resection or segmentectomy. Chest. 2014 Jan;145(1):66-71. doi: 10.1378/chest.13-1094. — View Citation

Wu W, He Z, Xu J, Wen W, Wang J, Zhu Q, Chen L. Anatomical Pulmonary Sublobar Resection Based on Subsegment. Ann Thorac Surg. 2021 Jun;111(6):e447-e450. doi: 10.1016/j.athoracsur.2020.10.083. Epub 2021 Jan 30. — View Citation

Wu WB, Xia Y, Pan XL, Wang J, He ZC, Xu J, Wen W, Xu XF, Zhu Q, Chen L. Three-dimensional navigation-guided thoracoscopic combined subsegmentectomy for intersegmental pulmonary nodules. Thorac Cancer. 2019 Jan;10(1):41-46. doi: 10.1111/1759-7714.12897. Epub 2018 Nov 3. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	5-year Disease-Free Survival	The time interval from randomization to the earliest onset of any of the following events: tumor local recurrence, distant metastasis, and mortality	From date of the recruitment, assessed up to 60 months
Secondary	30-day Morbidity and mortality rates	The rates of complications and death related to treatment during perioperative period	From date of the recruitment, assessed up to 30 days
Secondary	Pulmonary function in the first year after surgery	The Forced expiratory volume in one second (FEV1) in liter	From date of the 3rd, 6th, and 12th month after surgery
Secondary	3-year Disease-Free-Survival	The time interval from randomization to the earliest onset of any of the following events: tumor local recurrence, distant metastasis, and mortality	From date of the recruitment, assessed up to 36 months
Secondary	5-year overall Survival	The time interval from randomization to death caused by any reason	From date of the recruitment, assessed up to 60 months