UMIN-CTR Clinical Trial

Basic information
Public title	A randomized phase 2 study of TS-1 versus CDDP+VNR for adjuvant therapy in patients with non-small cell lung cancer
Acronym	LOGIK1702
Scientific Title	A randomized phase 2 study of TS-1 versus CDDP+VNR for adjuvant therapy in patients with non-small cell lung cancer
Scientific Title:Acronym	LOGIK1702
Region	Japan

Condition
Condition	Non-small-cell lung cancer
Classification by specialty	Medicine in general Pneumology Hematology and clinical oncology Chest surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	We evaluate effectiveness and safety of TS-1 monotherapy and CDDP+VNR combination therapy in patients with II/IIIA stage non-small-cell lung cancer which underwent a total resection. In addition, we also carry out the search of QOL and a productivity of the work and an activity disorder. At the same time, we intend to obtain information required to perform phase 3 randomized controlled trials planned in future precisely.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Two year relapse free survival
Key secondary outcomes	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.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Arm A (TS-1 monotherapy): adjuvant therapy of TS-1 for 16 courses (1 year) TS-1 80mg/m2 is orally administered twice dairy (after breakfast and dinner) from after breakfast at day 1 to after dinner at day 14 (or from after dinner at day1 to after breakfast at day 15) as 21 days of 1 course.
Interventions/Control_2	Arm B (CDDP + VNR combination therapy):TS-1 monotherapy): adjuvant therapy of CDDP+VNR for 4 courses CDDP 80mg/m2 at day1 and VNR 25mg/m2 at day 1, 8 are administered as 21 days of 1 course for 4 courses.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	75 years-old >=
Gender	Male and Female
Key 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 LC No.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 <= 1.5mg/dL Creatinine clearance >= 60 ml/min (actual value or converted value from serum creatinine level by Cockcroft-Gault formula)
Key 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.
Target sample size	190

Research contact person
Name of lead principal investigator	1st name Takeshi Middle name Last name Nagayasu
Organization	Nagasaki University Graduate School of Biomedical Sciences
Division name	Division of Surgical Oncology,
Zip code	852-8501
Address	1-7-1 Sakamoto, Nagasaki, Nagasaki 852-8501, Japan
TEL	095-819-7304
Email	nagayasu@nagasaki-u.ac.jp

Public contact
Name of contact person	1st name Tomoshi Middle name Last name Tsuchiya
Organization	Nagasaki University Graduate School of Biomedical Sciences
Division name	Division of Surgical Oncology,
Zip code	852-8501
Address	1-7-1 Sakamoto, Nagasaki, Nagasaki 852-8501, Japan
TEL	095-819-7304
Homepage URL
Email	tomoshi@nagasaki-u.ac.jp

Sponsor
Institute	Clinical Research Support Center Kyushu
Institute
Department

Funding Source
Organization	Taiho Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor	1)Lung Oncology Group in Kyushu(LOGIK)
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Nagasaki University Hospital Clinical Research Ethics Committee
Address	1-7-1 Sakamoto, Nagasaki, Nagasaki 852-8501, Japan
Tel	095-819-7905
Email	gaibushikin@ml.nagasaki-u.ac.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	長崎大学病院（長崎県）

Other administrative information
Date of disclosure of the study information	2017 Year 05 Month 22 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled	2
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Terminated
Date of protocol fixation	2017 Year 05 Month 02 Day
Date of IRB	2017 Year 05 Month 16 Day
Anticipated trial start date	2017 Year 06 Month 01 Day
Last follow-up date	2020 Year 11 Month 07 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2017 Year 05 Month 22 Day
Last modified on	2020 Year 11 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000031434