UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008174 |
|---|---|
| Receipt number | R000009631 |
| Scientific Title | Phase II study of S-1 for relapsed or refractory thymoma or thymic carcinoma |
| Date of disclosure of the study information | 2012/06/18 |
| Last modified on | 2019/12/20 11:49:35 |
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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
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
akinoue@idac.tohoku.ac.jp
Sponsor or person
Institute
North Japan Lung Cancer Group
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009631
