Comparison of Lobectomy and Segmentectomy for cT1aN0M0 Peripheral NSCLC

June 24, 2015 updated by: Zhejiang Cancer Hospital

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

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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

610

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Changchun Wang, MM
  • Phone Number: +86-571-88128062
  • Email: ccw7878@163.com

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310022
        • Zhejiang Cancer Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Age 18-70y

  2. 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.

  3. 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.

  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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: segmentectomy
Patients undergo anatomic segmentectomy by minimal incision thoracotomy or thoracoscopy/VATS.
Procedure: segmentectomy
segmentectomy in Arm I and lobectomy in Arm II
Active Comparator: lobectomy
Patients undergo lobectomy by minimal incision thoracotomy or thoracoscopy/VATS.
Procedure: segmentectomy
segmentectomy in Arm I and lobectomy in Arm II

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Relapse-free survival
Time Frame: 5 years
To evaluate the 5 year relapse-free survival (RFS) rate of two groups.
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
overall survival
Time Frame: 5 years
To evaluate the 5 year overall survival (OS) rate of two groups.
5 years
Pulmonary function
Time Frame: 6 months and 12 months
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
the duration of postoperative hospital stay
Time Frame: an expected average of 5 days
to evaluate the postoperative inpatient days of the two groups.
an expected average of 5 days
performance status
Time Frame: 12 months
to evaluate the postoperative performance status of the two groups by ECOG score standard.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zhejiang Cancer Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2015

Primary Completion (Anticipated)

July 1, 2022

Study Completion (Anticipated)

July 1, 2022

Study Registration Dates

First Submitted

June 16, 2015

First Submitted That Met QC Criteria

June 24, 2015

First Posted (Estimate)

June 25, 2015

Study Record Updates

Last Update Posted (Estimate)

June 25, 2015

Last Update Submitted That Met QC Criteria

June 24, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZhejiangCH

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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