Comparison of Lobectomy and Segmentectomy for cT1aN0M0 Peripheral NSCLC

Non-small Cell Lung Cancer Clinical Trial

Official title:

A Phase III Randomized Trial of Anatomical Segmentectomy Versus Lobectomy by Minimal Incision for Stage IA Peripheral Non-Small Cell Lung Cancer (≤ 2cm)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02481661
• Other study ID #: ZhejiangCH
• Status: Not yet recruiting
• Phase: Phase 3
• First received: June 16, 2015
• Last updated: June 24, 2015
• Start date: July 2015
• Est. completion date: July 2022

Study information

• Verified date: June 2015
• Source: Zhejiang Cancer Hospital
• Contact: Weimin Mao, MD
• Phone: +86-571-88122032
• Email: maowm1218[@]163.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

Anatomic segmentectomy may be a less invasive type of surgery than lobectomy for cT1aN0M0 peripheral NSCLC and may retain more pulmonary function. It is not yet known whether anatomic segmentectomy is non-inferior to lobectomy in treating stage IA non-small cell lung cancer. The aim of this study is to investigate whether the outcome of anatomic segmentectomy is similar to lobectomy for peripheral stage IA (≤ 2cm)non-small cell lung cancer (NSCLC).

Description:

Objective: To compare the outcomes(including 5 year relapse free survival rate, 5 year overall survival rate, retaining pulmonary function and the rates of loco-regional and systemic recurrence ) of patients with peripheral stage IA (≤ 2 cm) non-small cell lung cancer undergoing anatomic segmentectomy vs lobectomy. And to evaluate whether the anatomic segmentectomy is an optimal type of surgery for the patients with peripheral stage IA (≤ 2cm) non-small cell lung cancer (NSCLC).

Outline: This is a multicenter, prospective, randomized open phase III study of anatomic segmentectomy vs lobectomy for the patients with peripheral stage IA (≤ 2cm) non-small cell lung cancer (NSCLC). According to completely random block design, the patients are randomized to 1 of 2 treatment arms.

• Arm I: Patients undergo anatomic segmentectomy by minimal incision thoracotomy or thoracoscopy/VATS.

• Arm II: Patients undergo lobectomy by minimal incision thoracotomy or thoracoscopy/VATS.

Patients will be followed up every 3 months for the first year and then every 6 months for the subsequent 2 years and annually for 5 years postoperatively.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 610
• Est. completion date: July 2022
• Est. primary completion date: July 2022
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Age 18-70y

2. Preoperative criteria:

?)Center of tumor is located in the outer third of the lung field, and the maximal diameter = 2 cm(including coronal, traverse and sagittal view) confirmed by 1mm thin layer contrast-enhanced CT scan.

?)no hilar and mediastinal lymph node metastasis verified by mediastinoscope/EBUS.

3. Intraoperative criteria:

?)Adenocarcinama or squamous cell carcinoma of lung confirmed by frozen section.

?)Lobectomy, single segmentectomy or combined segmentectomy is feasible.

?)Confirmation of N0 status by frozen section examination of nodal levels 10 and 13 for segmentectomy, and 10 for lobectomy.

4. ECOG performance status 0-2.

5. No other malignancy within the past 3 years( except for well prognostic malignancy such as basal cell carcinoma of skin, superficial bladder cancer, or carcinoma in situ of the cervix).

6. No prior ipsilateral thoracotomy (prior diagnostic thoracoscopy is allowed).

7. No prior chemotherapy or radiation therapy.

8. Lobectomy is tolerated.

9. Sufficient organ functions.

10. Written informed consent.

Exclusion Criteria:

1. Active bacterial or fungous infection.

2. Simultaneous or metachronous (within the past 5 years) multiple cancers.

3. Interstitial pneumonitis, pulmonary fibrosis, or severe pulmonary emphysema, and can not tolerate lobectomy.

4. Psychosis.

5. Uncontrollable diabetes mellitus.

6. History of severe heart disease.

7. The maximal diameter of GGO=5mm.

8. N1, N2, or M1a is confirmed postoperatively.

9. Postoperative adjuvant therapy (chemotherapy ,radiotherapy or targeted therapy).

10. Other types of lung cancer such as small cell lung cancer, large cell lung cancer, etc.

11. Confirmation of benign disease by postoperative pathologic examination.

12. Lesion located in the middle lobe.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Non-small Cell Lung Cancer

Intervention

Procedure:
• segmentectomy
segmentectomy in Arm I and lobectomy in Arm II

Locations

Country	Name	City	State
China	Zhejiang Cancer Hospital	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Zhejiang Cancer Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Relapse-free survival	To evaluate the 5 year relapse-free survival (RFS) rate of two groups.	5 years	No
Secondary	overall survival	To evaluate the 5 year overall survival (OS) rate of two groups.	5 years	No
Secondary	Pulmonary function	to evaluate the pulmonary function as measured by expiratory flow rate of the two groups 6 months and 12 months postoperatively.	6 months and 12 months	No
Secondary	the duration of postoperative hospital stay	to evaluate the postoperative inpatient days of the two groups.	an expected average of 5 days	No
Secondary	performance status	to evaluate the postoperative performance status of the two groups by ECOG score standard.	12 months	No