UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006065 |
|---|---|
| Receipt number | R000007178 |
| Scientific Title | Phase II study of TS-1 + CPT-11 for squamous cell lung cancer previously treated with platinum |
| Date of disclosure of the study information | 2011/08/01 |
| Last modified on | 2020/02/03 10:20:36 |
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Basic information
Public title
Phase II study of TS-1 + CPT-11 for squamous cell lung cancer previously treated with platinum
Acronym
TS-1+CPT-11 for platinum-resistant squamous cell lung cancer
Scientific Title
Phase II study of TS-1 + CPT-11 for squamous cell lung cancer previously treated with platinum
Scientific Title:Acronym
TS-1+CPT-11 for platinum-resistant squamous cell lung cancer
Region
| Japan |
Condition
Condition
Non-small cell lung cancer (squamous cell carcinoma)
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of TS-1+CPT-11
Basic objectives2
Safety,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
TS-1+CPT-11
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. Pathologically proven squamous cell lung cancer
2. Previously treated with 1 or 2 regimen including at least one platinum regimen
3. With measurable lesion
4. With ECOG PS 0-1
5. With adequate organ function
6. With written informed consent
Key exclusion criteria
1. With obvious interstitial pneumonitis
2. With active other malignancies
3. With massive effusion required tube drainage
4. With severe comorbidities
5. With symptomatic brain metastasis
6. With other conditions that is considered inappropriate for the study by an attending physician
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Shunichi |
| Middle name | |
| Last name | Sugawara |
Organization
Sendai Kousei Hospital
Division name
Respiratory medicine
Zip code
980
Address
4-15, Hirosemachi, Aobaku, Sendai, Japan
TEL
+81-22-222-6111
swara357@cat-v.ne.jp
Public contact
Name of contact person
| 1st name | Akira |
| Middle name | |
| Last name | Inoue |
Organization
North Japan Lung Cancer Group
Division name
Office
Zip code
980-8575
Address
2-1, 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
North Japan Lung Cancer Group
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
Tohoku University Hospital IRB
Address
2-1, 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
| 2011 | Year | 08 | Month | 01 | 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
30
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
| 2011 | Year | 07 | Month | 28 | Day |
Date of IRB
| 2011 | Year | 07 | Month | 27 | Day |
Anticipated trial start date
| 2011 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 07 | Month | 28 | Day |
Last modified on
| 2020 | Year | 02 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007178
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
