UMIN-CTR Clinical Trial

Basic information
Public title	A phase II study of S-1 plus cisplatin with concurrent radiation for locally advanced thymic carcinoma (LOGIK1605/JART-1501)
Acronym	A phase II study of S-1 plus cisplatin with concurrent radiation for locally advanced thymic carcinoma (LOGIK1605/JART-1501)
Scientific Title	A phase II study of S-1 plus cisplatin with concurrent radiation for locally advanced thymic carcinoma (LOGIK1605/JART-1501)
Scientific Title:Acronym	A phase II study of S-1 plus cisplatin with concurrent radiation for locally advanced thymic carcinoma (LOGIK1605/JART-1501)
Region	Japan

Condition
Condition	Thymic carcinoma
Classification by specialty	Medicine in general Pneumology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	We investigate the efficacy and the safety of S-1 plus cisplatin with concurrent radiation in patients with locally advanced thymic carcinoma.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	response rate
Key secondary outcomes	Overall survival (OS) Progression free survival (PFS) Adverse event (AE)

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	1) S-1 is orally administered twice a day at day 1-14 and day 29-42. Dose of S-1: 80mg/m2/day, 40mg/m2/dose x 2 times 2) Cisplatin 60 mg/m2/day at day 1 and day29. 3) Daily radiation at 2.0 Gy/time from day 1 for 5times /weeks, total 30 times. Total radiation 60Gy. If the apparent effect of tumor reduction is observed by protocol treatment and a surgical resection is ethically required, surgical resection is applicable.
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.Patients with thymic carcinoma confirmed histologically. 2.Patients without treatment history of chemotherapy, radiation and surgical resection for thymic carcinoma. 3.Patients with unresectable locally advanced cancer and with Masaoka stage classification, stage III. Eligible for only metastasis to supraclavicular fossa or mediastinal lymph node with Masaoka stage classification, stage IVb. 4.Patients who is judged that radical irradiation is possible by a treatment plan of radiotherapist. 5.Patients without active double cancer. 6.Patient is at least 20 years of age (at enrollment date). 7.Performance status (ECOG): 0-1 8.The latest clinical laboratory test within 14 days prior to enrollment (it is eligible on the same day 2 weeks before the enrolment day) meets the following all standard. 1)WBC >= 3000/mm3 or neutrophil count >=1,500/mm3 2)Hemoglobin >= 9.0g/dL 3)Platelet count>= 100,000/mm3 4)AST, ALT < 100 IU/L 5)Total bilirubin <= 1.5mg/dL 6)Creatinine clearance >= 60 mL/min (Cockcroft-Gault method, 24 hrs method) 7)PaO2 >= 60 Torr or SpO2 >= 90% 9.Patients providing the written informed consent. 10.Patients with life expectancy of at least 3 months.
Key exclusion criteria	1. Patients who requires urgent radiation therapy with a symptom of superior vena cava syndrome. 2. Patients with serious complications : such as uncontrollable angina pectoris, myocardial infarction within 3 months and heart failure, uncontrollable diabetes mellitus,hypertension and serious infection. 3. Patients with interstitial pneumonia confirmed by chest X-ray. 4. Patients having complications judged to affect the enforcement of treatment. 5. Patients with anamnesis of severe hypersensitivity. 6. Patients with pregnant or possibly pregnant.Patients with nursing. 7. Patients who are different for the participation in the study by complication of mental disease or psychiatric symptom. 8. Any other patients who are regarded as unsuitable for this study by the investigators.
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Middle name Last name Minoru Fukuda
Organization	Nagasaki University Hospital
Division name	Clinical Oncology Center
Zip code
Address	1-7-1 Sakamoto, Nagasaki 852-8501, Japan
TEL	095-819-7779
Email	mifukuda258@nifty.com

Public contact
Name of contact person	1st name Middle name Last name (1)Minoru Fukuda (2) Takuya Yamazaki
Organization	Nagasaki University Hospital
Division name	(1)Clinical Oncology Center (2) Department of Radiological Sciences
Zip code
Address	1-7-1 Sakamoto, Nagasaki 852-8501, Japan
TEL	095-819-7779
Homepage URL
Email	mifukuda258@nifty.com

Sponsor
Institute	Clinical Research Support Center Kyushu
Institute
Department

Funding Source
Organization	Clinical Research Support Center Kyushu
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor	1) Lung Oncology Group in Kyushu (LOGIK) 2) Japanese Association for Research on the Thymus (JART)
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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（長崎県） 飯塚病院（福岡県） 九州大学（福岡県）国立病院機構大牟田病院（福岡県） 国立病院機構九州がんセンター （福岡県）国立病院機構福岡東医療センター（福岡県） 福岡大学 （福岡県） 佐賀大学 （佐賀県） 熊本大学（熊本県） 熊本地域医療センター（熊本県） 熊本中央病院（熊本県） 宮崎県立宮崎病院（宮崎県） 鹿児島市立病院（宮崎県） 鹿児島大学（鹿児島県） 国立病院機構沖縄病院（沖縄県） 下関市立市民病院（山口県） 沖縄県立南部医療センター・こども医療センター（沖縄県） 国立病院機構岩国医療センター（山口県） 国立病院機構近畿中央胸部疾患センター（大阪府） 大分大学（大分県） 大阪大学大学院医学系研究科（大阪府） 京都府立医科大学（京都府）

Other administrative information
Date of disclosure of the study information	2016 Year 10 Month 31 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	2016 Year 09 Month 26 Day
Date of IRB	2016 Year 11 Month 29 Day
Anticipated trial start date	2017 Year 01 Month 31 Day
Last follow-up date	2020 Year 10 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	2016 Year 10 Month 31 Day
Last modified on	2021 Year 03 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028349