Lung Neoplasms, Lymph Node Excision
Conditions
Keywords
Non-small cell lung cancer, Mediastinal lymph node dissection, Ground-glass nodules
Brief summary
Lung cancer is the leading cause of cancer related death worldwide. Lobectomy or sub-lobectomy with mediastinal lymph node dissection is the standard surgery. About 50% lung nodules are pure ground-glass or part-solid nodules. Non-solid nodules rarely develop mediastinal lymph node metastasis. The present study is a prospective, multicenter and randomized clinical trial, comparing the overall survival and disease-free survival of whether performing mediastinal lymph node dissection in non-small cell lung cancer with ground-glass nodule CT features.
Detailed description
The study is a non-inferior statistical comparison, with 681 patients in each group. The anticipated enroll period is 3 years, followed by observation period of 5 years.
Interventions
PROCEDURESystemic mediastinal lymph node dissection
Systematic hilar and mediastinal lymph node dissection.
PROCEDURESpared mediastinal lymph node dissection
Mediastinal lymph node is spared in this group.
Sponsors
Tianjin Medical University Cancer Institute and Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Thin-slice HRCT shows single GGN with C/T ≤ 0.5 and no lymph node metastasis; * Clinical stage IA NSCLC (TNM 8th classification) diagnosed prior or in surgery; * No history of malignancies within past 5 years or lung surgery; * No anti-cancer treatment prior to surgery.
Exclusion criteria
* Simultaneous or metachronous (within the past 5 years) double cancers; * Active bacterial or fungous infection; * Interstitial pneumonitis, pulmonary fibrosis, or severe pulmonary emphysema; * Systemic steroidal medication; * Uncontrollable diabetes mellitus; (vi) Uncontrollable hypertension or history of severe heart disease, heart failure.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival | 5 years | Overall survival is defined as days from randomization to death from any cause, and it was censored at the last day when the patient was alive. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of local recurrence | 5 years | Proportion of local recurrence in any kind of recurrences. |
| Duration of hospitalization | 1-60 days | Duration of hospitalization around surgery. |
| Relapse-free survival | 5 years | RFS time is defined as days from randomization to relapse or death for any patient. |
| Operation time | 20-180 minutes. | Time duration of surgery. |
| Blood loss | 1-60 days | Blood loss during surgery. |
| Duration of chest drainage tube placement | 1-60 days | Duration of chest drainage tube placement after surgery. |
Countries
China
Contacts
Primary ContactZhenfa Zhang, MD
Backup ContactChenguang Li, MD
Outcome results
None listed