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Comparison of Lobectomy and Segmentectomy for cT1aN0M0 Peripheral NSCLC

Primary Purpose

Non-small Cell Lung Cancer

Status

Unknown status

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

segmentectomy

About this trial

This is an interventional treatment trial for Non-small Cell Lung Cancer

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age 18-70y
Preoperative criteria:
ⅰ)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.
ⅱ)no hilar and mediastinal lymph node metastasis verified by mediastinoscope/EBUS.
Intraoperative criteria:
ⅰ)Adenocarcinama or squamous cell carcinoma of lung confirmed by frozen section.
ⅱ)Lobectomy, single segmentectomy or combined segmentectomy is feasible.
ⅲ)Confirmation of N0 status by frozen section examination of nodal levels 10 and 13 for segmentectomy, and 10 for lobectomy.
ECOG performance status 0-2.
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).
No prior ipsilateral thoracotomy (prior diagnostic thoracoscopy is allowed).
No prior chemotherapy or radiation therapy.
Lobectomy is tolerated.
Sufficient organ functions.
Written informed consent.

Exclusion Criteria:

Active bacterial or fungous infection.
Simultaneous or metachronous (within the past 5 years) multiple cancers.
Interstitial pneumonitis, pulmonary fibrosis, or severe pulmonary emphysema, and can not tolerate lobectomy.
Psychosis.
Uncontrollable diabetes mellitus.
History of severe heart disease.
The maximal diameter of GGO≤5mm.
N1, N2, or M1a is confirmed postoperatively.
Postoperative adjuvant therapy (chemotherapy ,radiotherapy or targeted therapy).
Other types of lung cancer such as small cell lung cancer, large cell lung cancer, etc.
Confirmation of benign disease by postoperative pathologic examination.
Lesion located in the middle lobe.

Sites / Locations

Zhejiang Cancer Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

segmentectomy

lobectomy

Arm Description

Patients undergo anatomic segmentectomy by minimal incision thoracotomy or thoracoscopy/VATS.

Patients undergo lobectomy by minimal incision thoracotomy or thoracoscopy/VATS.

Outcomes

Primary Outcome Measures

Relapse-free survival

To evaluate the 5 year relapse-free survival (RFS) rate of two groups.

Secondary Outcome Measures

overall survival

To evaluate the 5 year overall survival (OS) rate of two groups.

Pulmonary function

to evaluate the pulmonary function as measured by expiratory flow rate of the two groups 6 months and 12 months postoperatively.

the duration of postoperative hospital stay

to evaluate the postoperative inpatient days of the two groups.

performance status

to evaluate the postoperative performance status of the two groups by ECOG score standard.

Full Information

NCT ID

NCT02481661

First Posted

June 16, 2015

Last Updated

June 24, 2015

Sponsor

Zhejiang Cancer Hospital

1. Study Identification

Unique Protocol Identification Number

NCT02481661

Brief Title

Comparison of Lobectomy and Segmentectomy for cT1aN0M0 Peripheral NSCLC

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)

Study Type

Interventional

2. Study Status

Record Verification Date

June 2015

Overall Recruitment Status

Unknown status

Study Start Date

July 2015 (undefined)

Primary Completion Date

July 2022 (Anticipated)

Study Completion Date

July 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Zhejiang Cancer Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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).

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Non-small Cell Lung Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

610 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

segmentectomy

Arm Type

Experimental

Arm Description

Patients undergo anatomic segmentectomy by minimal incision thoracotomy or thoracoscopy/VATS.

Arm Title

lobectomy

Arm Type

Active Comparator

Arm Description

Patients undergo lobectomy by minimal incision thoracotomy or thoracoscopy/VATS.

Intervention Type

Procedure

Intervention Name(s)

segmentectomy

Intervention Description

segmentectomy in Arm I and lobectomy in Arm II

Primary Outcome Measure Information:

Title

Relapse-free survival

Description

To evaluate the 5 year relapse-free survival (RFS) rate of two groups.

Time Frame

5 years

Secondary Outcome Measure Information:

Title

overall survival

Description

To evaluate the 5 year overall survival (OS) rate of two groups.

Time Frame

5 years

Title

Pulmonary function

Description

to evaluate the pulmonary function as measured by expiratory flow rate of the two groups 6 months and 12 months postoperatively.

Time Frame

6 months and 12 months

Title

the duration of postoperative hospital stay

Description

to evaluate the postoperative inpatient days of the two groups.

Time Frame

an expected average of 5 days

Title

performance status

Description

to evaluate the postoperative performance status of the two groups by ECOG score standard.

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age 18-70y Preoperative criteria: ⅰ)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. ⅱ)no hilar and mediastinal lymph node metastasis verified by mediastinoscope/EBUS. Intraoperative criteria: ⅰ)Adenocarcinama or squamous cell carcinoma of lung confirmed by frozen section. ⅱ)Lobectomy, single segmentectomy or combined segmentectomy is feasible. ⅲ)Confirmation of N0 status by frozen section examination of nodal levels 10 and 13 for segmentectomy, and 10 for lobectomy. ECOG performance status 0-2. 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). No prior ipsilateral thoracotomy (prior diagnostic thoracoscopy is allowed). No prior chemotherapy or radiation therapy. Lobectomy is tolerated. Sufficient organ functions. Written informed consent. Exclusion Criteria: Active bacterial or fungous infection. Simultaneous or metachronous (within the past 5 years) multiple cancers. Interstitial pneumonitis, pulmonary fibrosis, or severe pulmonary emphysema, and can not tolerate lobectomy. Psychosis. Uncontrollable diabetes mellitus. History of severe heart disease. The maximal diameter of GGO≤5mm. N1, N2, or M1a is confirmed postoperatively. Postoperative adjuvant therapy (chemotherapy ,radiotherapy or targeted therapy). Other types of lung cancer such as small cell lung cancer, large cell lung cancer, etc. Confirmation of benign disease by postoperative pathologic examination. Lesion located in the middle lobe.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Weimin Mao, MD

Phone

+86-571-88122032

maowm1218@163.com

First Name & Middle Initial & Last Name or Official Title & Degree

Changchun Wang, MM

Phone

+86-571-88128062

ccw7878@163.com

Facility Information:

Facility Name

Zhejiang Cancer Hospital

City

Hangzhou

State/Province

Zhejiang

ZIP/Postal Code

310022

Country

China

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Changchun Wang, MM

Phone

+86-571-88128062

ccw7878@163.com

12. IPD Sharing Statement

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Comparison of Lobectomy and Segmentectomy for cT1aN0M0 Peripheral NSCLC

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