UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010736 |
|---|---|
| Receipt number | 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 | 2021/04/02 17:20:49 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
y-okuma@cick.jp
Sponsor or person
Institute
Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012528
