Trimodality with Adjuvant Radiation in Stage 3A/3B-N2 Non-small Cell Lung Cancer

JRCT ID: jRCT1051180028

Registered date:17/01/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Non-small cell lung cancer
• Date of first enrollment: 07/03/2019
• Target sample size: 25
• Study type: Interventional
• Intervention(s): Chemotherapy, surgery, radiation

Outcome(s)

• Primary Outcome: Treatment completion
• Secondary Outcome: Response of induction chemotherapy, treatment related adverse events, progression free survival, Overall survival

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 75age old
• Gender: Both

Include criteria

1. c-stage 3A/3B with pathologically diagnosed N2 without chest wall invasion
2.Resectable following induction chemotherapy
3.Normal pulmonary function within 56days before IC
4.No previous chemotherapy or thoracic radiation
5.age 20-75 years at IC
6.ECOG Performance Status0-1
7.Normal bone marrow, liver, and renal function below within 28days before IC
8.Written informed consent was obtained

Exclude criteria

1.Unresectable extra-nodal mediastinal lymph node in CT
2.Contraindication for CBDCA or nab-PTX
3.Past history of severe drug allergy
4.Pulmonary dysfunction
5.Myocardial infarction within 180 days before IC
6.Interstitial pneumonia or pulmonary fibrosis detected in CT 56days before IC
7.Medication with PSL more than 10mg/day 90days before IC
8.Clinically relevant heart disease
9.Clinically relevant psychological disorder
10.Uncontrollable DM
11.Clinically relevant infection disease
12.Other clinically relevant comorbidity
13.Active double cancer
14.Pregnant, lactating, possibly pregnant
15.Inappropriate by investigator

Related Information

• Primary Sponsor: Inoue Masayoshi
• Source(s) of Monetary Support: Uehara Memorial Foundation
• Secondary ID(s): UMIN000025010