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

JRCT ID: jRCTs071180083

Registered date:29/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Non-small cell lung cancer
• Date of first enrollment: 29/03/2019
• Target sample size: 58
• Study type: Interventional

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 Outcome: 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 Outcome: Safety and efficacy

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 80age old
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Suzuki Makoto
• Secondary Sponsor: Ikeda Koei