Comparison Between Wedge Resection and Segmentectomy for Ground Glass Opacity- Dominant Stage IA NSCLC

NCT02718365 | Unknown DMC

• 1 other identifier: TSCI002
• Study Type: interventional
• Target: 1,382
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate whether the long-term outcome and safety of wedge resection are comparable to segmentectomy for the surgical treatment of early stage (IA) non-small cell lung cancer (NSCLC). Zhang et al. performed a meta-analysis of 53 studies and suggested that sublobectomy achieved a survival rate comparable to lobectomy in a selected population of patients with Stage I NSCLC. However, one critical question needs to be addressed, that is, does sublobectomy require segmentectomy or wedge resection? Cho et al. reported that, for pulmonary ground glass opacity (GGO) nodules (Stage IA NSCLC), wedge resection achieved a 5-year survival rate of 98.6% in the pure GGO group and 95.5% in the mixed GGO group. Cho et al. cautioned against performing wedge resection for mixed GGO nodules with GGO component ≤ 75%, due to the high recurrence rate. When radiology shows that the GGO component is ≥75%, pathology usually finds that the lesions are non-invasive. Therefore, these lesions are potential candidates for wedge resection. This randomized clinical trial is to assess whether wedge resection can be established as a standard treatment for Stage IA NSCLC with tumor size ≤ 2 cm and GGO component ≥ 75%.

Conditions

Lung Neoplasms; Surgery

Keywords

Lung Neoplasms; Surgery; VATS; GGO; GGN; Segmentectomy; Wedge Resection; Prognosis

Outcome Measures

Primary Outcomes (1)

• 5-year Progression-Free-Survival

  From date of the recruitment, assessed up to 60 months

Secondary Outcomes (5)

• 3-year Progression-Free-Survival

  From date of the recruitment, assessed up to 36 months

• 5-year overall survival

  From date of the recruitment, assessed up to 60 months

• Pulmonary function in the first year after surgery

  From date of the 1 month\ 3 months\ 6 months\ 12 months after surgery in every recruited patient

• 30-day Morbidity and mortality rates

  From date of the recruitment, assessed up to 30 days

• 10-year overall survival

  From date of the recruitment, assessed up to 120 months

Study Arms (2)

Group A

EXPERIMENTAL

Wedge resection

Procedure: Wedge resection

Group B

ACTIVE COMPARATOR

Segmentectomy

Procedure: Segmentectomy

Interventions

Wedge resection PROCEDURE

A wedge resection is the surgical removal of the lung tumor with a small portion of the lung that surrounds the tumor. Hilar and mediastinal lymph nodes should be resected or sampled.

Group A

Segmentectomy PROCEDURE

A segmentectomy removes a segment of a lung lobe anatomically, or inclusion of a portion of adjacent segment, but does not remove the whole lung lobe. Hilar and mediastinal lymph nodes should be resected or sampled.

Group B

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Preoperative thin-section computed tomography (TSCT) will fulfill all of the following conditions:
• Lung cancer is suspected.
• Lesion size is more than 5 mm but equal to or less than 20 mm.
• Consolidation/tumor (C/T) ratio is equal to or less than 0.25.
• The center of the tumor is located in the outer third of the lung field.
• Preoperative TSCT estimates a surgical margin of more than1.5 cm or the tumor's diameter.
• Preoperative clinical staging: T1a-T1bN0M0 (according to UICC2017-8thTNM staging).
• R0 resectable in segmentectomy and wedge resections plus mediastinal lymph node resection.
• Aged 18 to 75 years old.
• No prior chemotherapy or thoracic radiation therapy for any malignant diseases.
• Preoperative FEV1.0\>=1.0 L.
• Performance status of ECOG 0 or 1.
• Preoperative ASA scoring (American society of anesthesiology) class I -III.
• Sufficient organ functions.
• The patient agrees to participate in the trial and signs the informed consent form.

You may not qualify if:

• Quit smoking \<2 weeks.
• Preoperative FEV1 \< 50% of the expected value.
• Mediastinal lymph node metastasis confirmed by biopsy.
• Pregnant or lactating women.
• Serious mental illness.
• With other malignant disease history within 5 years.
• With the history of unstable angina or myocardial infarction within 6 months.
• With the history of cerebral infarction or cerebral hemorrhage within 6 months.
• With the history of sustained systemic corticosteroid therapy within 1 month.
• The patient requires simultaneous surgical treatment of other diseases.
• TSCT shows that the lesion is located in the right middle lobe.

Sponsors & Collaborators

• West China Hospital: lead

Study Sites (1)

West China Hospital, Sichuan University

Chengdu, Sichuan, 610041, China

RECRUITING

Related Publications (5)

• National Lung Screening Trial Research Team; Aberle DR, Adams AM, Berg CD, Black WC, Clapp JD, Fagerstrom RM, Gareen IF, Gatsonis C, Marcus PM, Sicks JD. Reduced lung-cancer mortality with low-dose computed tomographic screening. N Engl J Med. 2011 Aug 4;365(5):395-409. doi: 10.1056/NEJMoa1102873. Epub 2011 Jun 29.

  PMID: 21714641 BACKGROUND

• Zhang Y, Sun Y, Wang R, Ye T, Zhang Y, Chen H. Meta-analysis of lobectomy, segmentectomy, and wedge resection for stage I non-small cell lung cancer. J Surg Oncol. 2015 Mar;111(3):334-40. doi: 10.1002/jso.23800. Epub 2014 Oct 16.

  PMID: 25322915 BACKGROUND

• Hida Y, Teramura K, Muto J, Ohtaka K, Hase R, Nakada R, Watanabe Y, Matsui Y, Kaga K. [Indication of limited pulmonary resection for small-sized lung cancer based on preoperative clinical data]. Kyobu Geka. 2012 Jan;65(1):52-7. Japanese.

  PMID: 22314158 BACKGROUND

• 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.

  PMID: 24551879 BACKGROUND

• Cho JH, Choi YS, Kim J, Kim HK, Zo JI, Shim YM. Long-term outcomes of wedge resection for pulmonary ground-glass opacity nodules. Ann Thorac Surg. 2015 Jan;99(1):218-22. doi: 10.1016/j.athoracsur.2014.07.068. Epub 2014 Nov 15.

  PMID: 25440277 BACKGROUND

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Mastectomy, Segmental

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Mastectomy; Surgical Procedures, Operative

Study Officials

• Lunxu Liu, M.D., Ph.D.

  Department of Thoracic Surgery, West China Hospital, Sichuan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hu Liao, M.D.

CONTACT

+86 28 85422494; liaotiger_198653@163.com

Liyan Chen, M.Sc.

CONTACT

+86 28 85422494; lilianchan7786@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chair of Department of Thoracic Surgery

Study Record Dates

• First Submitted: October 4, 2015
• First Posted: March 24, 2016
• Study Start: December 7, 2017
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2024
• Last Updated: October 12, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)