A phase II trial of induction CDDP plus TS-1 with concurrent radiotherapy followed by surgical resection in patients with resectable stage IIIA-N2 non-small cell lung cancer

A phase II trial of induction CDDP plus TS-1 with concurrent radiotherapy followed by surgical resection in patients with resectable stage IIIA-N2 non-small cell lung cancer - A phase II trial of induction chemoradiotherapy followed by surgery in patients with resectable stage IIIA-N2 NSCLC

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000018138

Enrollment

Registered

2015-06-30

Start date

2015-07-09

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

Stage IIIA-N2 non-small cell lung cancer

Interventions

Induction concurrent chemoradiotherapy (CDDP +TS-1+ RT50Gy) The surgical resection is performed after 2 cycles of chemotherapy with CDDP, TS-1 and RT50Gy.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)Histologically or cytologically proven non-small cell lung cancer, diagnosed using specimen material obtained from primary tumor or metastastatic lymph node 2)Stage IIIA- resectable N2 disease without previously treatment for lung cancer 3)Age>=20, <75 y 4)Patient who can ingest orally 5)ECOG PS 0-1 6)Adequate organ function neutrophil count>=2,000/mm3 blood platelet count>=100,000/mm3 hemoglobin>=9.0g/dL total bilirubin<=1.5mg/dL AST,ALT<=100IU/L PaO2>=60Torr or SpO2>=94% CCr>=60ml/min 7)Written informed consent

Exclusion criteria

Exclusion criteria: 1)History of active infection 2)Severe diarrhea 3)Severe complication (Severe GI disease, bowel obstruction, interstitial pneumonia or pulmonary fibrosis detectable on chest Xp, uncontrollable diabetes mellitus, history of severe heart disease, severe renal disease, severe hepatic disease, Current history of GI ulcer, Current history of myocardial infarction and angina pectoris) 4)Autoimmune disease requiring immunosuppressive agent 5)History of active double cancer 6)History of pregnancy or lactation 7)History of psychiatric disorder 8)Systemic administration of steroid 9)Severe drug allergy 10) Hepatitis Bc antibody or hepatitis Bs antigen positive 11)Administration of flucytosine 12)Investigational new drug or the unapproved drug is administered 13)Any other medical condition that makes the patient unsuitable for inclusion in the study according to the opinion of the investigator

Design outcomes

Primary

Measure	Time frame
2-year overall survival	—

Secondary

Measure	Time frame
Overall survival Progression-free survival Postoperative recurrence free survival Response rate Pathological complete response rate Frequency and grade of adverse event	—

Countries

Japan

Contacts

Public ContactYoichi Ohtaki

Gunma University Hospital General Thoracic Surgery, Integrative center of general surgery

yohtakiadvanced@gmail.com027-220-8245

Outcome results

None listed

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