Mediastinal Lymph Node Dissection Versus Spared Mediastinal Lymph Node Dissection in Stage I GGN NSCLC

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorTianjin Medical University Cancer Institute and Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Systemic mediastinal lymph node dissection

    Procedure/Surgery

    Systematic hilar and mediastinal lymph node dissection.

  • Spared mediastinal lymph node dissection

    Procedure/Surgery

    Mediastinal lymph node is spared in this group.

Treatment groups

1,362 Participants
are divided into 2 treatment groups
Group A: Mediastinal lymph node dissection groupExperimental treatment 1 intervention
Group B: Spared mediastinal lymph node dissection groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Overall survival

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.

Time frame
5 years

Secondary outcomes

1

Relapse-free survival

RFS time is defined as days from randomization to relapse or death for any patient.

Time frame
5 years
2

Proportion of local recurrence

Proportion of local recurrence in any kind of recurrences.

Time frame
5 years
3

Duration of hospitalization

Duration of hospitalization around surgery.

Time frame
1-60 days
4

Duration of chest drainage tube placement

Duration of chest drainage tube placement after surgery.

Time frame
1-60 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.