Postoperative radiotherapy (PORT) for pathological N2 non-small cell lung cancer with adjuvant chemotherapy: a randomized phase III trial (JCOG1916, J-PORT)

Phase 3

Recruiting

• Conditions: pathological N2 non-small cell lung cancer

• Registration Number: JPRN-UMIN000042905
• Lead Sponsor: Japan Clinical Oncology Group (JCOG)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-01-05
• Last Update Posted: 17 October 2023
• Study Completion: 2032-01-05

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 330

Inclusion Criteria

Not provided

Exclusion Criteria

(1)History of synchronous or metachronous (within 3 years) malignancies (2)Active infection requiring systemic therapy (3)Fever with a body temperature higher than 38.0 degrees Celsius at the time of registration (4)Pregnant, possibly pregnant, within 28 days of delivery, breastfeeding females, or males expecting to father a child (5)Psychiatric illnesses or symptoms affecting the daily lives (6)Systemic treatment with steroids or immunosuppressive agents (7)Unstable angina(diagnosis or worsening of chest pain within 3 weeks) or history of myocardial infarction within 6 months prior to the registration

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
relapse-free survival

Secondary Outcome Measures

Name	Time	Method
overall survival, proportion of patients completing radiotherapy in arm B, early adverse events, late adverse events in arm B, severe adverse events, local recurrence