Status:
ENROLLING_BY_INVITATION
Comparison of Sublobar and Lobectomy in Small (2 Cm or Less 0.5<CTR<1) Non-small Cell Lung Cancer: a Prospective, Multicenter Randomized Controlled Study
Lead Sponsor:
Xiaolong Yan, Dr.
Conditions:
NSCLC, Stage I
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
The early NSCLC（Non-small cell lung cancer） patients with partial solid nodules mainly composed of solid components, whose maximum tumor diameter was ≤ 2.0cm and 0.5\<CTR（Consolidation tumor ratio）\<1...
Detailed Description
Since Cahan reported on "radical lobectomy" in 1960, lobectomy has become the standard surgical method for lung cancer, and its efficacy has long been verified in clinical practice. In 2006, the Natio...
Eligibility Criteria
Inclusion
- nitial inclusion criteria:
- Age 18-75 years old, regardless of gender;
- ECOG PS score 0-1 points (Attachment 3.4);
- Preoperative clinical staging for patients with suspected NSCLC lesions in Phase I (according to AJCC Eighth Edition staging standards, Attachment 3.5);
- Thin slice CT indicates that the maximum tumor diameter is ≤ 2.0cm;
- Pre operative CT prompts 0.5\<CTR\<1.0;
- Good lung function (FEV1\>1.5 L or FEV1% ≥ 60%), able to tolerate both segmental resection and lobectomy;
- The number of pulmonary nodules that need to be processed is ≤ 3, and the nodules are located in the same side of the lung;
- Those who voluntarily sign the research informed consent form can comply with the research visit plan and other protocol requirements.
Exclusion
- Initial exclusion criteria:
- Hypertension and diabetes difficult to control;
- Pregnant or lactating women;
- Those who have received anti-tumor treatment (radiotherapy, chemotherapy, Targeted therapy, immunotherapy) before surgery;
- Previous history of lung surgery;
- Interstitial pneumonia, Pulmonary fibrosis or severe Emphysema;
- Those who undergo thoracotomy or change the surgical plan due to various reasons during surgery;
- Severe mental illness;
- Individuals with a history of severe heart disease, heart failure, myocardial infarction, or angina within the past 6 months;
- Active bacterial or fungal infections that are difficult to control;
- Individuals who have conducted other clinical trials in the three months prior to enrollment.
- Secondary exclusion criteria:
- The postoperative pathological result was Benign tumor;
- Postoperative pathological results of non NSCLC malignant tumors;
- Non small cell lung cancer confirmed histologically during operation, but with malignant Pleural effusion and pleural dissemination
Key Trial Info
Start Date :
January 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2030
Estimated Enrollment :
660 Patients enrolled
Trial Details
Trial ID
NCT06028412
Start Date
January 1 2023
End Date
December 31 2030
Last Update
October 15 2024
Active Locations (1)
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1
The Second Affiliated Hospital of Air Force Medical University University of PLA
Xi'an, Shannxi, China