Phase II trial of cisplatin and TS-1 with radiotherapy for patients with locally advanced N2 non-small cell lung cancer

Phase II trial of cisplatin and TS-1 with radiotherapy for patients with locally advanced N2 non-small cell lung cancer - Phase II trial of cisplatin and TS-1 with radiotherapy for patients with locally advanced N2 non-small cell lung cancer

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000012455

Enrollment

Registered

2013-12-02

Start date

2013-12-02

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

S-1:80mg/m2 (d1-d15) q4w x 4 cycles CDDP:60 mg/m2(d1) q4w x 4 cycles RT: 66 Gy/33frs

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Patients with histlogically or cytologically confirmed non-small cell lung cancer 2) Prior treatment of radiotherapy, chemotherapy or surgery for Patients with stage IIIA or IIIB 3)Prior treatment of chemoradiotherapy or chemotherapy for non-small cell lung cancer patients for up to 1 regimen in the EGFR-TKI untreated 4) Unresectable lung cancer 5) 20<=, <80years old 6)PS:0-1 (ECOG) 7)adequate bone marrow,liver,and renal functions WBC count >= 4,000/mm3, Neutrophil counts >= 2,000/mm3 Platelets >= 100,000/mm3 Hemoglobin concentration >= 9.0g/dL Total bilirubin <= 1.5mg/dL AST and ALT >=100IU/L SpO2(Room air) >=90% Creatinine clearance >= 60 mL/min, 8)written informed consent

Exclusion criteria

Exclusion criteria: 1) SVC syndrome 2)Active infection more than and equal to grade 2 3) Continuous watery diarrhea 4) Significant comorbid disease such as paresis of intestine, ileus, interstitial pneumonia, lung fibrosis, uncontrolled diabetes mellitus, cardiac failure, renal failure, hepatic failure, active gastrointestinal ulcer, myocardial infarction and angina pectoris within 6 months, other uncontrolled disease 5) Continuous administration of a steroid 6) Active concomitant malignancy except carcinoma in situ, intramucosal carcinoma or cancer with more than 5 year disease free 7) Pregnant status or lactation 8) Uncontrolled psychiatric disease 9) Patients required for continuing steroid therapy 10) Severe drug allergy 11) Being treated with flucytosine. 12)Participation in other registration trial before randomization in this trial 13) Any patients judged by the investigator to be unfit to participate in the study

Design outcomes

Primary

Measure	Time frame
2 years survival rate	—

Secondary

Measure	Time frame
Response rate, Progression-free survival, Overall survival, Surgery transition rate, Rate and incidence of adverse events	—

Countries

Japan

Contacts

Public ContactToshinari Ema

Itabashi central medical center Department of Thoracic Surgery

toshinariema09@yahoo.co.jp03-3967-0572

Outcome results

None listed

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