UMIN-CTR Clinical Trial

Basic information
Public title	Feasibility study of adjuvant chemotherapy with S-1 plus cisplatin for stage II-IIIA non-small cell lung cancer
Acronym	S-1 + CDDP for adjuvant chemotherapy in NSCLC
Scientific Title	Feasibility study of adjuvant chemotherapy with S-1 plus cisplatin for stage II-IIIA non-small cell lung cancer
Scientific Title:Acronym	S-1 + CDDP for adjuvant chemotherapy in NSCLC
Region	Japan

Condition
Condition	Non-small cell lung cancer
Classification by specialty	Pneumology Chest surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the feasibility of S-1 plus cisplatin as adjuvant chemotherapy for stage II-IIIA non-small cell lung cancer after curative resection.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	Completion rate of four cycles of S-1 plus cisplatin.
Key secondary outcomes	Overall survival, time to treatment failure, relapse-free survival, toxicity, dose delivery, recurrent status

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	Four cycles of S-1 plus cisplatin as adjuvant chemotherapy
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	75 years-old >
Gender	Male and Female
Key inclusion criteria	1) Pathologically diagnosed non-small cell lung cancer 2) pStage II-IIIA 3) Completely resected 4) Surgically treated patients 5) ND2a-2 or more 6) No prior therapy 7) ECOG Perfomance Status 0-1 8) Age 20-75 year-old 9) Able to oral intake 10) Adequate organ function 11) PaO2 >= 65mmHg or SpO2 >= 92% 12) Able to start within 8 weeks after the surgery 13) Written informed concent
Key exclusion criteria	1) Drug allergy 2) Administering Flucytosine 3) Interstitial pneumonia 4) Serious medical complications 5) Diarrhea 6) Active double malignancies 7) Mental status 8) Pregnancy, breastfeeding or suspected of being pregnant 9) Pneumonectomy 10) Others judged by attending physician
Target sample size	42

Research contact person
Name of lead principal investigator	1st name Akira Middle name Last name Iyoda
Organization	Toho University Omori Medical Center
Division name	Chest Surgery
Zip code	143-8541
Address	6-11-1 Omori-nishi, Ota-ku, Tokyo
TEL	03-3752-4151
Email	aiyoda@med.toho-u.ac.jp

Public contact
Name of contact person	1st name Atsushi Middle name Last name Sano
Organization	Toho University Omori Medical Center
Division name	Chest Surgery
Zip code	143-8541
Address	6-11-1 Omori-nishi, Ota-ku, Tokyo
TEL	03-3752-4151
Homepage URL
Email	sanoa-tky@umin.ac.jp

Sponsor
Institute	Division of Chest Surgery, Toho University Omori Medical Center
Institute
Department

Funding Source
Organization	Division of Chest Surgery, Toho University Omori Medical Center
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	Division of Respirology and General Thoracic Surgery, NTT Medical Center Tokyo Department of Thoracic and Cardiovascular Surgery, Self-Defense Forces Central Hospital Division of Thoracic and Cardiovascular Surgery, Showa University School of Medicine Respiratory Disease Center, Showa University Northern Yokohama Hospital Division of Chest Surgery and Respiratory Medicine, Toho University Omori Medical Center Division of Surgery, Toho University Ohashi Medical Center Division of Surgery, Toho University Sakura Medical Center Department of Respiratory Medicine, Toranomon Hospital Department of Thoracic Surgery, Mitsui Memorial Hospital Division of General Thoracic Surgery, Yokosuka Kyosai Hospital
Name of secondary funder(s)	None

IRB Contact (For public release)
Organization	the Ethics Committee of Toho University Omori Medical Center
Address	6-11-1 Omori-nishi, Ota-ku, Tokyo
Tel	03-3762-4151
Email	somu.omori@jim.toho-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

Other administrative information
Date of disclosure of the study information	2015 Year 01 Month 12 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
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 01 Month 15 Day
Date of IRB	2013 Year 01 Month 15 Day
Anticipated trial start date	2013 Year 02 Month 01 Day
Last follow-up date	2018 Year 02 Month 28 Day
Date of closure to data entry
Date trial data considered complete	2018 Year 02 Month 28 Day
Date analysis concluded

Other
Other related information

Management information
Registered date	2015 Year 01 Month 12 Day
Last modified on	2021 Year 05 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018790