A phase II feasibility study of surgical intervention for single station cN2 (UICC 6) non-small cell lung cancer (JNETS 0801)

A phase II feasibility study of surgical intervention for single station cN2 (UICC 6) non-small cell lung cancer (JNETS 0801) - Feasibility study of surgery for single station cN2

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000013247

Enrollment

Registered

2014-02-24

Start date

2008-10-30

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-small cell lung cancer

Interventions

Surgery Lobectomy or Pneumonectomy Systematic lymphnode dissection (ND2a-2 or more than that is required)

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Those who have single station metastatic N2 nodes evaluated by computed tomography in patiets with non-small cell lung cancer will be enrolled in this study. (With above 10mm and below 20mm in those shorter diameter are defined as positive nodes.) Acquitision of lung cancer diagnosis is not required before surgical treatment.

Exclusion criteria

Exclusion criteria: Mediastinal lymphnodes with above 20mm in their shorter diameter. cN2 with over 2 stations. General contraindication for the thoracotomy with low cardio-pulmonary function, liver or renal dysfunction and the others. Age over 76. Extra-nodal invation of cN2 nodes. Distant metastasis. Other malignancies. #1-3(UICC 6) lymphnodes swelling in left side mediastinum. preceding hemotherapy, molecular targetting therapy, thoracic radiotherapy

Design outcomes

Primary

Measure	Time frame
Single station cN2 definition is as follows. Above 10mm and below 20mm in those diameters are evaluated as metastatic nodes by computed tomography, and such positive nodes without spreading more than 2 stations are considered single station cN2. (Regardless of the status of N1 node, PET observations and patho-cytological diagnosis for those nodes) After registration, patients with single station cN2 NSCLC will take lobectomy or pneumonectomy with systematic lymphnode dissection. In some patients, adjuvant chemotherapy after the decision of pathological stating would be recommended. Primary end points of this study are overall survival (3 and 5 years) and disease specific survival (3 and 5 years).	—

Measure

Time frame

Single station cN2 definition is as follows. Above 10mm and below 20mm in those diameters are evaluated as metastatic nodes by computed tomography, and such positive nodes without spreading more than 2 stations are considered single station cN2. (Regardless of the status of N1 node, PET observations and patho-cytological diagnosis for those nodes) After registration, patients with single station cN2 NSCLC will take lobectomy or pneumonectomy with systematic lymphnode dissection. In some patients, adjuvant chemotherapy after the decision of pathological stating would be recommended. Primary end points of this study are overall survival (3 and 5 years) and disease specific survival (3 and 5 years).

—

Countries

Japan

Contacts

Public ContactSatomi Takahashi

Miyagi Cancer Center Department of thoracic surgery

takahashi-sa469@miyagi-pho.jp+81-22-384-3151

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026