NCT02481661

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
610

participants targeted

Target at P75+ for phase_3 nonsmall-cell-lung-cancer

Timeline
Completed

Started Jul 2015

Typical duration for phase_3 nonsmall-cell-lung-cancer

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 16, 2015

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 25, 2015

Completed
6 days until next milestone

Study Start

First participant enrolled

July 1, 2015

Completed
7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2022

Completed
Last Updated

June 25, 2015

Status Verified

June 1, 2015

Enrollment Period

7 years

First QC Date

June 16, 2015

Last Update Submit

June 24, 2015

Conditions

Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

  • Relapse-free survival

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

    5 years

Secondary Outcomes (4)

  • overall survival

    5 years

  • Pulmonary function

    6 months and 12 months

  • the duration of postoperative hospital stay

    an expected average of 5 days

  • performance status

    12 months

Study Arms (2)

segmentectomy

EXPERIMENTAL

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

Procedure: segmentectomy

lobectomy

ACTIVE COMPARATOR

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

Procedure: segmentectomy

Interventions

segmentectomyPROCEDURE

segmentectomy in Arm I and lobectomy in Arm II

lobectomysegmentectomy

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310022, China

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Mastectomy, Segmental

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

MastectomySurgical Procedures, Operative

Central Study Contacts

Weimin Mao, MD

CONTACT

+86-571-88122032maowm1218@163.com

Changchun Wang, MM

CONTACT

+86-571-88128062ccw7878@163.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 16, 2015

First Posted

June 25, 2015

Study Start

July 1, 2015

Primary Completion

July 1, 2022

Study Completion

July 1, 2022

Last Updated

June 25, 2015

Record last verified: 2015-06

Locations

CN(1)