UMIN-CTR Clinical Trial

Basic information
Public title	Phase II study of S-1 for relapsed or refractory thymoma or thymic carcinoma
Acronym	S-1 for Relapsed or Refractory Thymoma/Thymic Cancer
Scientific Title	Phase II study of S-1 for relapsed or refractory thymoma or thymic carcinoma
Scientific Title:Acronym	S-1 for Relapsed or Refractory Thymoma/Thymic Cancer
Region	Japan

Condition
Condition	Thymoma/Thymic carcinoma
Classification by specialty	Pneumology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy and safety of S-1 in patients with relapsed or refractory thymoma or thymic carcinoma. And also to analyse correlation between efficacy of S-1 treatment and expression of fluoropyrimidine metabolizing enzyme such as TS, DPD, OPRT.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Response rate
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	S-1 treatment S-1 is administered orally twice daily after morning and evening meals at a dose of 40-60 mg (80-120 mg/day), depending on the BSA from days 1 to 14, which is followed by 7 days rest. Courses of S-1 treatment will be repeated every 3weeks until discontinuation criteria are met.
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	100 Not applicable >=
Gender	Male and Female
Key inclusion criteria	1. Histologically proven thymoma or thymic carcinoma 2. Unsuitable for curative radiotherapy or Unresectable 3. At least 1 prior chemotherapy 4. Progressive disease after the most recent chemotherapy regimen. 5. ECOG performance status 0-2 6. Age of 20 years or older 7. Presence of measurable lesions, as defined per RECIST 1.1 8. Adequate organ function 9. Life expectancy of at least 2 months 10. Written informed consent
Key exclusion criteria	1. Serious uncontrolled infections or body temperature higher than 38 degree centigrade 2. Continuous administration of an oral steroid or an immunosuppressive agent 3. With severe concurrent disease 4. Symptomatic brain metastasis 5. With malignant pleural, peritoneal effusion requiring drainage or pericardial effusion 6. With severe drug allergies 7. Contraindication with S-1 8. Previous treatment with fluoropyrimidines such as S-1, UFT 9. Current use of flucytosine 10. With interstitial pneumonitis or pulmonary fibrosis detectable on chest X-ray 11. Lactating, pregnant or possibly pregnant women, or those willing to become pregnant 12. Physician concludes that the patient's participation in this trial is inappropriate
Target sample size	42

Research contact person
Name of lead principal investigator	1st name Akira Middle name Last name Inoue
Organization	Tohoku University Hospital
Division name	Department of Respiratory Medicine
Zip code	9808575
Address	1-1, Seiryomachi, Aobaku, Sendai
TEL	+22-22-717-8539
Email	akinoue@idac.tohoku.ac.jp

Public contact
Name of contact person	1st name Akira Middle name Last name Inoue
Organization	Tohoku University Hospital
Division name	Department of Respiratory Medicine
Zip code	9808575
Address	1-1, Seiryocho, Aobaku, Sendai
TEL	+81-22-717-8539
Homepage URL
Email	akinoue@idac.tohoku.ac.jp

Sponsor
Institute	North Japan Lung Cancer Group
Institute
Department

Funding Source
Organization	Tohoku University Hospital
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	CRIETO, Tohoku University Hospital
Address	1-1, Seiryomachi, Aobaku Sendai
Tel	022-717-7100
Email	akinoue@idac.tohoku.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	2012 Year 06 Month 18 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications
Number of participants that the trial has enrolled	40
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	2012 Year 06 Month 15 Day
Date of IRB	2012 Year 05 Month 27 Day
Anticipated trial start date	2012 Year 06 Month 01 Day
Last follow-up date	2019 Year 05 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2012 Year 06 Month 14 Day
Last modified on	2019 Year 12 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000009631