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

October 13, 2012
October 15, 2012
November 2012
November 2020   (final data collection date for primary outcome measure)
overall survival [ Time Frame: 5y ] [ Designated as safety issue: No ]
To evaluate the 5 year overall survival (OS) rate of two groups.
Same as current
Complete list of historical versions of study NCT01707888 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
Comparison of Lobectomy and Sublobar Resection for Chinese cT1aN0M0 Peripheral Non-small Cell Lung Cancer
A Phase III Randomized Trial of Lobectomy Versus Sublobar Resection for Small (≤ 2 CM) Peripheral Non-Small Cell Lung Cancer in Chinese Population

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Non-small Cell Lung Cancer
  • 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
  • Procedure: Thoracotomy
    Patients undergo lobectomy, wedge resection, or anatomic segmentectomy by thoracotomy.
    Other Name: Open surgery
  • Active Comparator: Lobectomy
    Patients undergo lobectomy by thoracotomy or thoracoscopy/VATS.
    Intervention: Procedure: Thoracotomy
  • Experimental: Sublobar
    Patients undergo sublobar resection(wedge resection or anatomic segmentectomy) by thoracotomy or thoracoscopy/VATS.
    Intervention: Procedure: Thoracoscopy/VATS

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
1100
Not Provided
November 2020   (final data collection date for primary outcome measure)

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.
Both
18 Years to 70 Years
No
Contact: Jun Wang, MD 88324078 Jwangmd@yahoo.com
China
 
NCT01707888
PEKUPH1201
No
Jun Wang, Peking University People's Hospital
Peking University People's Hospital
Guangdong Association of Clinical Trials
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
Peking University People's Hospital
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP