NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCTs071180083

Registered date:29/03/2019

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

Basic Information

Recruitment status Not Recruiting
Health condition(s) or Problem(s) studiedNon-small cell lung cancer
Date of first enrollment23/10/2013
Target sample size58
Countries of recruitment
Study typeInterventional
Intervention(s)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 this clinical study. CDDP 60mg/m2 ,day1 TS-1 80mg/m2 ,day1-14 q3-4weeks , 3 cycles TS-1 80mg/m2 alternate-day administrations : TS-1 is administered orally at Monday, Wednesday, Friday and Sunday from start of administration day to the day corresponding to one year after surgery.

Outcome(s)

Primary OutcomeTo 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 OutcomeSafety and efficacy

Key inclusion & exclusion criteria

Age minimum>= 20age old
Age maximum< 80age old
GenderBoth
Include criteria1) 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
Exclude criteria1)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

Related Information

Contact

Public contact
Name Makoto Suzuki
Address 1-1-1 Honjo Chuo-ku Kumamoto City Kumamoto Japan 8608556
Telephone +81-963735533
E-mail smakoto@kumamoto-u.ac.jp
Affiliation Kumamoto University Hospital
Scientific contact
Name Makoto Suzuki
Address 1-1-1 Honjo Chuo-ku Kumamoto City Kumamoto Japan 860-8556
Telephone +81-963735533
E-mail smakoto@kumamoto-u.ac.jp
Affiliation Kumamoto University Hospital