Comparison of Lobectomy and Sublobar Resection for Chinese cT1aN0M0 Peripheral Non-small Cell Lung Cancer

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified October 2012 by Peking University People's Hospital
Sponsor:
Collaborator:
Guangdong Association of Clinical Trials
Information provided by (Responsible Party):
Jun Wang, Peking University People's Hospital
ClinicalTrials.gov Identifier:
NCT01707888
First received: October 13, 2012
Last updated: October 15, 2012
Last verified: October 2012
  Purpose

Surgery may be the best treatment choice for early stage non-small cell lung cancer. And Sublobar resection(Wedge resection or anatomic segmentectomy) may be less invasive procedure than lobectomy with similar long-term outcome and less risk and improved recovery.There were few data of this issue in china.The aim of this study is to investigate the outcome of lobectomy versus sublobar resection for small (≤ 2cm) peripheral stage IA non-small cell lung cancer (NSCLC) in china.


Condition Intervention Phase
Non-small Cell Lung Cancer
Procedure: Thoracoscopy/VATS
Procedure: Thoracotomy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase III Randomized Trial of Lobectomy Versus Sublobar Resection for Small (≤ 2 CM) Peripheral Non-Small Cell Lung Cancer in Chinese Population

Resource links provided by NLM:


Further study details as provided by Peking University People's Hospital:

Primary Outcome Measures:
  • overall survival [ Time Frame: 5y ] [ Designated as safety issue: No ]
    To evaluate the 5 year overall survival (OS) rate of two groups.


Secondary Outcome Measures:
  • Disease-free survival [ Time Frame: 5y ] [ Designated as safety issue: No ]
    To evaluate Disease Free Survival (DFS) of two groups.

  • Rate of loco-regional and systemic recurrence [ Time Frame: 5y ] [ Designated as safety issue: No ]
    To evaluate the rate of loco-regional and systemic recurrence of the two groups.

  • Pulmonary function [ Time Frame: 6 months after surgery ] [ Designated as safety issue: No ]
    to evaluate the pulmonary function as measured by expiratory flow rate of the two groups 6 months postoperatively.

  • Postoperative hospital stay. [ Time Frame: 3 months postoperatively ] [ Designated as safety issue: Yes ]
    to evaluate the postoperative hospital stay of the two groups

  • Postoperative drainage duration [ Time Frame: 3 months postoperatively ] [ Designated as safety issue: Yes ]
    to evaluate the postoperative drainage duration of the two groups.

  • postoperative morbidity and mortality [ Time Frame: 3 months postoperatively ] [ Designated as safety issue: Yes ]
    to evaluate the postoperative morbidity and mortality of the two groups.


Estimated Enrollment: 1100
Study Start Date: November 2012
Estimated Primary Completion Date: November 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Lobectomy
Patients undergo lobectomy by thoracotomy or thoracoscopy/VATS.
Procedure: Thoracotomy
Patients undergo lobectomy, wedge resection, or anatomic segmentectomy by thoracotomy.
Other Name: Open surgery
Experimental: Sublobar
Patients undergo sublobar resection(wedge resection or anatomic segmentectomy) by thoracotomy or thoracoscopy/VATS.
Procedure: Thoracoscopy/VATS
Patients undergPatients undergo lobectomy, wedge resection, or anatomical segmentectomy by thoracoscopic surgery or video assisted thoracoscopic surgery.
Other Name: Minimal invasive surgery

Detailed Description:

The prospective randomized LCSG trial of lobectomy versus limited resection for stage IA non-small cell lung cancer (NSCLC) disproved sublobar resection as a comparable surgical treatment to lobectomy. However, the role of sublobar resection is still in dispute considering the dramatic improvement in radiographic technology, minimal invasive surgical technique and significant advances in our understanding of the biology of NSCLC in the subsequent 20 years. And Recent meta-analysis revealed survival after limited resection for stage I lung cancer was comparable to that after lobectomy. This is a nationwide, multicenter, prospective, randomized open phase III study, aimed To evaluate the 5 year overall survival (OS) rate of two types of surgery. Patients are stratified according to tumor size, histology, smoking status and institutions. Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients undergo lobectomy by thoracotomy or thoracoscopy/VATS.
  • Arm II: Patients undergo sublobar resection(wedge resection or anatomical segmentectomy) by thoracotomy or thoracoscopy/VATS.

patients will be followed up every 6 months for 2 years and annually for 5 years postoperatively.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age 18-70y
  2. Preoperative criteria:

    i) non-small cell lung cancer is suspected, ii) no larger than 2cm in maximal diameter, iii) Center of tumor is located in the outer third of the lung field, iv) the tumor is not located at middle lobe, v) no hilar and mediastinal lymph node metastasis, vi)no pure GGO.

  3. Intraoperative criteria:

    i) Histologically confirmed NSCLC, ii) technically possible to perform any of the following procedures: lobectomy, segmentectomy, and nodal dissection.

  4. No prior ipsilateral thoracotomy (prior diagnostic thoracoscopy is allowed).
  5. No prior chemotherapy or radiation therapy for any malignant diseases.
  6. Expected postoperative FEV1.0>=800 mL and PaO2>=65 torr.
  7. Performance status of 0 or 1.
  8. Sufficient organ functions.
  9. preoperative body temperature is 38C or less
  10. Written informed consent.

Exclusion Criteria:

  1. Active bacterial or fungous infection.
  2. Simultaneous or metachronous (within the past 5 years) double cancers.
  3. Women during pregnancy or breast-feeding.
  4. Interstitial pneumonitis, pulmonary fibrosis, or severe pulmonary emphysema.
  5. Psychosis.
  6. Systemic steroids medication.
  7. Uncontrollable diabetes mellitus.
  8. Uncontrollable hypertension.
  9. History of severe heart disease, heart failure, myocardial infarction within the past 6 months or attack of angina pectoris within the past 6 months.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01707888

Contacts
Contact: Jun Wang, MD 88324078 Jwangmd@yahoo.com

Locations
China
Peking university people's hospital Not yet recruiting
Beijing, China
Contact: Jun Wang, MD         
Beijing Friendship Hospital Not yet recruiting
Beijing, China
Contact: Min Gong         
the second Xiangya hospital of Central South University Not yet recruiting
Changsha, China
Contact: Fenglei Yu         
Fuzhou General Hospital of Nanjing Military Command Not yet recruiting
Fuzhou, China
Contact: Shengsheng Yang         
Fuzhou Pulmonary Hospital of Fujian Not yet recruiting
Fuzhou, China
Contact: Zujian Dai         
Fujian Provincial Hospital Not yet recruiting
Fuzhou, China
Contact: Xiaojie Pan         
Guangdong General Hospital Not yet recruiting
Guangdong, China
Contact: Yi-Long Wu, MD         
First Hospital of Jilin University Not yet recruiting
Jilin, China
Contact: Guoguang Shao         
Jiangsu Cancer Institute & Hospital Not yet recruiting
Nanjing, China
Contact: Lin Xu         
Principal Investigator: Lin Xu         
Shanghai chest hospital Not yet recruiting
Shanghai, China
Contact: Heng Zhao         
Shanghai Zhongshan Hospital Not yet recruiting
Shanghai, China
Contact: Qun Wang         
Shanghai Pulmonary Hospital Not yet recruiting
Shanghai, China
Contact: Gening Jiang         
Sponsors and Collaborators
Peking University People's Hospital
Guangdong Association of Clinical Trials
Investigators
Study Chair: Jun Wang, MD Peking University People's Hospital
Study Director: Fan Yang, MD Peking University People's Hospital
Study Director: Zhao Xi Sui, MD Peking University People's Hospital
  More Information

Publications:
Responsible Party: Jun Wang, Principal Investigator, Clinical Professor, Peking University People's Hospital
ClinicalTrials.gov Identifier: NCT01707888     History of Changes
Other Study ID Numbers: PEKUPH1201
Study First Received: October 13, 2012
Last Updated: October 15, 2012
Health Authority: China: Food and Drug Administration

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on August 26, 2014