OGIK1702

Phase 2

• Conditions: on-small-cell lung cancer

• Registration Number: JPRN-jRCTs071180010
• Lead Sponsor: Matsumoto Keitaro

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-12-17
• Last Update Posted: 27 May 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

1) Patients providing the written informed consent.
2) Patients with non-small-cell lung cancer histopathologically confirmed (except neuroendocrine carcinoma, mucoepidermoid carcinoma, adenoid cystic carcinoma).
3) Patients with total resection in pathological clinical stage II - IIIA which 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 should be dissected obeys the following criteria.
Right upper lobe lung cancer (LC) No. 2R, 4R
Left upper lobe segmentum superius LC No. 4L-6
Right middle lobe LC No. 2R, 4R, 7
Left upper lobe lingual LCNo. 4L-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 56days after the operation at the enrollment (it is eligible on the same day 4 weeks and 8 weeks before the enrolment day).
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) Performance status (ECOG): 0-1
10) Patients having sufficient bone marrow, liver and renal function tolerable to chemotherapy (however, the following clinical laboratory test should be confirmed by the data within 14 days prior to enrollment).
White blood cell count 3,000-12,000/mm3
Platelet count >= 100,000/mm3
Haemoglobin >= 9.0g/dL
Total bilirubin <= 1.5mg/dL
AST, ALT <=100 IU/ml
BUN <= 25mg/dL
SpO2 >=90% or PaO2 >= 70 mmHg
Creatinine :Facility standard value or Creatinine clearance >= 60 ml/min
(actual value or converted value from serum creatinine level by Cockcroft-Gault formula)

Exclusion Criteria

1) Patients with active double cancer (synchronous double cancer and asynchronous double cancer within 5 years of progression-free period. However, the lesions correspondent to carcinoma in situ of uterine cervix curable by topical treatment, resectable gastric cancer/colorectal cancer by endoscope and topically resectable skin cancer other than malignant melanoma are excluded from active double cancer).
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 with pregnant or possibly pregnant (will), or nursing.
8)Patients under treatment of type of fluorinated pyrimidine antineoplastic.
9)Patients under treatment of flucytosine.
10)Any other patients who are regarded as unsuitable for this study by the investigators.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Two year relapse free survival

Secondary Outcome Measures

Name	Time	Method
Treatment completion rate, incidence of adverse event, relative dose density, 2 year overall survival, 5 year overall survival, 2 year relapse free survival, 5 year relapse free survival, productivity of the work and activity disorder, quality of adjusted life year (QALY) converted from EQ-5D-5L.