UMIN-CTR Clinical Trial

Basic information
Public title	Phase II trial of S-1 treatment as palliative-intent chemotherapy for previously treated advanced thymic carcinoma
Acronym	S-1 for thymic carcinoma
Scientific Title	Phase II trial of S-1 treatment as palliative-intent chemotherapy for previously treated advanced thymic carcinoma
Scientific Title:Acronym	S-1 for thymic carcinoma
Region	Japan

Condition
Condition	thymic carcinoma
Classification by specialty	Pneumology Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy of S-1 treatment for previous treated advanced thymic carcinoma
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	response rate
Key secondary outcomes	progression-free survival, overall survival, toxicity, number of cycles

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) with basing on the BSA for 2 weeks-on, which is followed by 1 week-off. Cycles of S-1 treatment will be repeated every 3 weeks until discontinuation criteria is 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	18 years-old <
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1. The patients who were definitively diagnosed with having thymic carcinoma 2. Unsuitable for curative-intent treatment and previously treated with at least 1 prior cisplatin-based chemotherapy 3. Age of 18 years or older 4. ECOG performance status 0-2 5. presence of measurable lesion with RECIST 1.1 criteria 6. With the status of previous treatment (surgery, radiotherapy, or chemotherapy) at the time of beginning of S-1 chemotherapy 7. Adequate organ function 8. Life expectancy of at least 12 weeks 9. Written informed consent
Key exclusion criteria	1. With severe drug allergies for tegafur 2. With severe myleosuppression, renal disturbance, or liver disturbance 3. Current use of flucytosine 4. With severe uncontrolled systemic complication 5. Serious uncontrolled infections 6. With concrrent other malignant tumro 7. With malignant pleural, peritoneal effusion requiring drainage or pericardial effusion 8. With continuous diarrhea 9. With bowel paralysis or obstruction 10. With interstitial pneumonitis or pulmonary fibrosis detectable on chest X-ray 11.Symptomatic or uncontrolled brain metastasis 12. The patients treated with unapproved drugs within 30 days 13. Lactating, pregnant or possibly pregnant women, or those willing to become pregnant 14. Unable to intake orally
Target sample size	26

Research contact person
Name of lead principal investigator	1st name Yukio Middle name Last name Hosomi
Organization	Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital
Division name	Department of Thoracic Oncology and Respiratory Medicine
Zip code	113-8677
Address	Honkomagome 3-18-22, Bunkyo, Tokyo
TEL	03-3823-2101
Email	yhosomi@cick.jp

Public contact
Name of contact person	1st name Yusuke Middle name Last name Okuma
Organization	Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital
Division name	Department of Thoracic Oncology and Respiratory Medicine
Zip code	113-8677
Address	Honkomagome 3-18-22, Bunkyo, Tokyo
TEL	03-3823-2101
Homepage URL
Email	y-okuma@cick.jp

Sponsor
Institute	Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital
Institute
Department

Funding Source
Organization	Tokyo Metropolitan Cancer and Infectious diseases Center Komagome 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	Ethics committee of Tokyo Metropolitan Komagome Hospital
Address	Honkomagome 3-18-22, Bunkyo, Tokyo
Tel	03-3823-2101
Email	rinri@cick.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	公益財団法人がん研究会有明病院（東京都） がん・感染症センター都立駒込病院（東京都） 国立がん研究センター中央病院（東京都）

Other administrative information
Date of disclosure of the study information	2013 Year 05 Month 16 Day

Related information
URL releasing protocol	https://onlinelibrary.wiley.com/doi/10.1002/cam4.3385
Publication of results	Published

Result
URL related to results and publications	https://onlinelibrary.wiley.com/doi/10.1002/cam4.3385
Number of participants that the trial has enrolled	26
Results	One patient showed complete response and seven patients showed partial responses, resulting in a 30.8% response rate (90% confidence interval [CI], 18.3-46.9) and an 80.8% disease control rate (90% CI, 65.4-90.3) in 25 pts. The median PFS was 4.3 months (95% CI, 2.3-10.3 months) and median OS was 27.4 months (95% CI, 16.6-34.3). Adverse events of greater than 3 included neutropenia (12%), skin rash (8%), elevated alanine aminotransferase, and fatigue (4%). No treatment related death was observed.
Results date posted	2021 Year 04 Month 02 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results	2020 Year 08 Month 19 Day
Baseline Characteristics	Registered.
Participant flow	Registered.
Adverse events	Registered.
Outcome measures	Registered.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Main results already published
Date of protocol fixation	2013 Year 04 Month 01 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 03 Month 31 Day
Date of closure to data entry	2018 Year 03 Month 31 Day
Date trial data considered complete	2018 Year 03 Month 31 Day
Date analysis concluded	2018 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date	2013 Year 05 Month 16 Day
Last modified on	2021 Year 04 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012528