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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000009845
Receipt No. R000011537
Scientific Title A phase II trial of S-1 monotherapy for relapsed thymoma and thymic carcinoma: Okayama Lung Cancer Study Group Trial (OLCSG 1302)
Date of disclosure of the study information 2013/02/01
Last modified on 2013/08/23

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Basic information
Public title A phase II trial of S-1 monotherapy for relapsed thymoma and thymic carcinoma: Okayama Lung Cancer Study Group Trial (OLCSG 1302)
Acronym S-1 monotherapy for relapsed thymoma and thymic carcinoma.
Scientific Title A phase II trial of S-1 monotherapy for relapsed thymoma and thymic carcinoma: Okayama Lung Cancer Study Group Trial (OLCSG 1302)
Scientific Title:Acronym S-1 monotherapy for relapsed thymoma and thymic carcinoma.
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 monotherapy for relapsed thymoma or thymic carcinoma. Secondary endpoints are progression free survival and overall survival. 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 Progression free survival
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

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 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Katsuyuki Kiura
Organization Okayama University Hospital
Division name Department of Allergy and Respiratory Medicine
Zip code
Address 2-5-1, shikatacho, kitaku, okayama
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Yuka Kato
Organization Okayama University Hospital
Division name Department of Allergy and Respiratory Medicine
Zip code
Address
TEL 086-235-7227
Homepage URL
Email

Sponsor
Institute Okayama Lung Cancer Study Group(OLCSG)
Institute
Department

Funding Source
Organization Okayama 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
Address
Tel
Email

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
2013 Year 02 Month 01 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
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 Terminated
Date of protocol fixation
2013 Year 02 Month 01 Day
Date of IRB
Anticipated trial start date
2013 Year 02 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 01 Month 23 Day
Last modified on
2013 Year 08 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011537

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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