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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000010736
Receipt No. R000012528
Scientific Title Phase II trial of S-1 treatment as palliative-intent chemotherapy for previously treated advanced thymic carcinoma
Date of disclosure of the study information 2013/05/16
Last modified on 2019/03/22

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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
Publication of results Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled 26
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 No longer recruiting
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
2019 Year 03 Month 22 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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