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Table 1 Main Inclusion and Exclusion Criteria

From: A randomized phase II study of S-1 monotherapy versus cisplatin with vinorelbine for completely resected stage II/IIIA non-small cell lung cancer: rationale and study protocol design for the LOGIK1702 study

Inclusion Criteria

1) Patients providing the written informed consent

2) Patients with non-small-cell lung cancer histopathologically confirmed

3) Patients with total resection in pathological clinical stage II - IIIA with more than one lobe excision was carried out

4) Patients with lymphadenectomy more than ND2a-1 or selective lymphadenectomy

 The selection method of the mediastinal lymph node dissected obeys the following criteria

Right upper lobe lung cancer (LC); No.2R,4R

Left upper lobe segmentum superius LC; No. 4 L-6

Right middle lobe LC;

No.2R,4R,7

Left upper lobe lingual LC; No.4 L-7

Right lower lobe LC; No.7–9

Left lower lobe LC; No.7–9

5) Patients without pre-treatment (radiation, chemotherapy) other than surgical treatment

6) Patients who passed more than 28 days and less than 56 days after the operation at enrollment

7) Patient is at least 20 years and less than 75 years of age (at enrollment date).

8) Patients capable of treatment with oral medicine.

9) Eastern Cooperative Oncology Group (ECOG) performance status of 0–1

10) Patients having sufficient bone marrow, liver and renal function tolerable to chemotherapy

Exclusion Criteria

1) Patients with active double cancer (synchronous double cancer and asynchronous double cancer within 5 years of progression-free  period)

2) Patients with anamnesis of drug-induced hypersensitivity.

3) Patients with severe postoperative complications (such as postoperative infection, rapture suture).

4) Patients with severe complications (such as diarrhoea, intestinal paralysis, ileus, uncontrollable diabetes mellitus, heart failure, kidney failure, liver failure).

5) Patients with interstitial pattern recognized as apparent interstitial pneumonia in chest CT.

6) Patients with active infection.

7) Female patients pregnant or possibly pregnant (will), or nursing.

8) Patients under treatment with a type of fluorinated pyrimidine antineoplastic.

9) Patients under treatment of flucytosine.