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A Phase III Randomized Trial of Lobectomy Versus Sublobar Resection for Small (≤ 2 CM) Peripheral Non-Small Cell Lung Cancer in Chinese Population


Phase 3
18 Years
70 Years
Not Enrolling
Both
Non-small Cell Lung Cancer

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Trial Information

A Phase III Randomized Trial of Lobectomy Versus Sublobar Resection for Small (≤ 2 CM) Peripheral Non-Small Cell Lung Cancer in Chinese Population


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.


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

overall survival

Outcome Description:

To evaluate the 5 year overall survival (OS) rate of two groups.

Outcome Time Frame:

5y

Safety Issue:

No

Principal Investigator

Jun Wang, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Peking University People's Hospital

Authority:

China: Food and Drug Administration

Study ID:

PEKUPH1201

NCT ID:

NCT01707888

Start Date:

November 2012

Completion Date:

Related Keywords:

  • Non-Small Cell Lung Cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

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