UMIN-CTR Clinical Trial

Basic information
Public title	Phase II study of alternate-day treatment with S-1 as adjuvant chemotherapy for patients with lung cancer.
Acronym	Phase II study of alternate-day treatment with S-1 as adjuvant chemotherapy for patients with lung cancer.
Scientific Title	Phase II study of alternate-day treatment with S-1 as adjuvant chemotherapy for patients with lung cancer.
Scientific Title:Acronym	Phase II study of alternate-day treatment with S-1 as adjuvant chemotherapy for patients with lung cancer.
Region	Japan

Condition
Condition	lung cancer
Classification by specialty	Chest surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	A phase II study, that alternate-day S-1 is administered to patients with lung cancer,postoperatively, is carried out to confirm the feasibility,effectiveness and safety of the treatment.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	The ratio of the patients who completed the course
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Adjuvant treatment of S-1 is administered on alternate-day for 1 year after surgery.
Interventions/Control_2
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	Not applicable
Gender	Male and Female
Key inclusion criteria	1. histologically proven non-small cell lung cancer with stage IB to IIIA 2. curative resection (R0) at the prior surgery 3.without any prior radiation therapy, chemotherapy for primary lung cancer. 4. age: 20< years old 5. PS(ECOG): 0 or 1 6. without any other severe diseases WBC 3,000<= and => 12,000/mm3 Platelet 100,000/mm3 <= Hemoglobin 9.0 g.dl <= Total bilirubin 1.5 mg/dl => AST, ALT 100 IU/L <= SPO2 90% <= or PaO2 60mmHg <= Creatinin clearance 40 ml/min/body <= **Cockcroft-Gault method is available 7.patients who can start adjuvant treatment within 8 weeks postoperatively. 8. written informed consents
Key exclusion criteria	1) patients who cannot take S-1 1.with severe allergic history against the ingredients of S-1. 2. with sever bone marrow suppression, renal or liver dysfunction 3. patients who need other fluorouracil 4. patients who need flucitosine. 2) with severe allergic history against medicines 3) with history of myocardial infarction in 6 months. 4)with other severe diseases (cardiac failure,mental disorder, infection or other severe complications) 5) with uncontrolled DM 6) with watery diarrhea 7) with double cancer and or multiple cancer 8)doctors' stop not to register to the study
Target sample size	25

Research contact person
Last name of lead principal investigator	1st name Ichiro Middle name Last name Yoshino
Organization	Chiba University Graduate School of Medicine
Division name	Department of General Thoracic Surgery
Zip code	260-8670
Address	1-8-1, Inohana, Chiba, 260-8670, Japan
TEL	043-222-7171
Email	iyoshino@faculty.chiba-u.jp

Public contact
1st name of contact person	1st name Hidemi Middle name Last name Suzuki
Organization	Chiba University Graduate School of Medicine
Division name	Department of General Thoracic Surgery
Zip code	260-8670
Address	1-8-1, Inohana, Chiba, 260-8670, Japan
TEL	043-222-7171
Homepage URL
Email	hidemisuzukidesu@yahoo.co.jp

Sponsor
Institute	Chiba University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Chiba University Graduate School of Medicine
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Chiba University Hospital Clinical Research Center
Address	1-8-1, Inohana, Chiba, 260-8670, Japan
Tel	043-226-2616
Email	prc-jim@chiba-u.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

Other administrative information
Date of disclosure of the study information	2013 Year 08 Month 05 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	25
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	Completed
Date of protocol fixation	2013 Year 03 Month 25 Day
Date of IRB	2013 Year 05 Month 01 Day
Anticipated trial start date	2013 Year 05 Month 01 Day
Last follow-up date	2018 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2013 Year 08 Month 04 Day
Last modified on	2019 Year 03 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000013304