Feasibility study of adjuvant chemotherapy with cisplatin(CDDP) and TS-1 in followed by alternate-day treatment with TS-1 in patients with completely resected pathological II-IIIA non small cell lung cancer

Feasibility study of adjuvant chemotherapy with cisplatin(CDDP) and TS-1 in followed by alternate-day treatment with TS-1 in patients with completely resected pathological II-IIIA non small cell lung cancer - None

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTs071180083

Enrollment

Registered

2019-03-29

Start date

2013-10-23

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

Adjuvant chemotherapy as written the followings are performed on patients underwent complete surgical resection, and with pathological Stage II and Stage IIIA. Patients who provided the agreement of t

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Pathologically confirmed diagnosis of NSCLC. 2) Non-small cell lung cancer with stage II-IIIA 3) Completely resected 4) Oral intake 5) LN dissection more than ND2a-1 6) Neither previous chemotherapy nor radiotherapy before operation 7) Performance Status (ECOG) 0-2 8) Aged 20-75 years old 9)Have adequate organ function within 14 days before study entry a.Leukocyte count 3,000/mm3 or over b.Granulocyte count 1,500/mm3 or over c.Platelet count 100,000/mm3 or over d.Hb 9.0 g/dl or over e.AST(GOT) 2.5 x the Upper Limits of Normal(ULN) or under f.ALT(GPT) 2.5 x the Upper Limits of Normal (ULN) or under g.Total bilirubin 1.5 mg/dL or under h.Serum creatinine 1.5 mg/dl or under i. creatinine clearance 50 mL / min or over j.PaO2 60torr or over or SpO2 90% or over 10) Written informed consent to participate. 11) Possible to receive chemotherapy within 8 week after surgery

Exclusion criteria

Exclusion criteria: 1)Anamnesis of hypersensitivity to drugs 2)Massive pleural or pericardial effusion 3) With active double cancer 4)Severe complication (ileus , interstitial pneumonia , interstitial pneumonia , pulmonary fibrosis, uncontrolled diabetes , heart failure , renal failure, hepatic failure, and so on) 5) With active infections 6) With a difficult bowel movement 7) Pleural effusion, cardiac effusion, or cardiac effusion necessitating treatment. 8) Pregnancy or lactating patients 9) Uncontrolled psychiatric disease 10)With poor-controlled diabetes mellitus 11) Concurrent steroid therapy 12) With HBs or HCV 13) With HIV 14) Physician judged improper to entry this trial

Design outcomes

Primary

Measure	Time frame
To explore feasibility of cisplatin(CDDP) and TS-1 followed by alternate-day treatment with TS-1 in patients with completely resected pathological II-IIIA non small cell lung cancer	—

Secondary

Measure	Time frame
Safety and efficacy	—

Contacts

Public ContactMakoto Suzuki

Kumamoto University Hospital

smakoto@kumamoto-u.ac.jp+81-963735533

Outcome results

None listed

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