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

Phase 1

• Conditions: on-small cell lung cancer

• Registration Number: JPRN-jRCTs071180083
• Lead Sponsor: Suzuki Makoto

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-03-29
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 58

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified