UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005702 |
|---|---|
| Receipt number | R000006741 |
| Scientific Title | A phase II study of maintenance S-1 after induction therapy of platinum doublet chemotherapy in patients with squamous cell carcinoma of the lung |
| Date of disclosure of the study information | 2011/06/01 |
| Last modified on | 2019/06/14 15:34:13 |
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Basic information
Public title
A phase II study of maintenance S-1 after induction therapy of platinum doublet chemotherapy in patients with squamous cell carcinoma of the lung
Acronym
A phase II study of maintenance S-1 after induction therapy of platinum doublet chemotherapy in patients with squamous cell carcinoma of the lung
Scientific Title
A phase II study of maintenance S-1 after induction therapy of platinum doublet chemotherapy in patients with squamous cell carcinoma of the lung
Scientific Title:Acronym
A phase II study of maintenance S-1 after induction therapy of platinum doublet chemotherapy in patients with squamous cell carcinoma of the lung
Region
| Japan |
Condition
Condition
squamous cell carcinoma of the lung
Classification by specialty
| Pneumology | Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Clinical usefulness of maintenance S1 after induction therapy of platinum doublet chemotherapy
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
PFS
Key secondary outcomes
RR(Maintenance),OS(MST),
compliance (Maintenance),
TS, DPD OPRT(5-Fu related molecules)
AE
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
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 Maintenance
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Sqamous cell carcinoma of the lung was confirmed cytological or pathological examiation.
2. stage IIIB or IV and reccurent cases after resection.
3. age 20-80 years
4. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.
5. tumor with negative or unkown for EGFR senstive mutation.
6. CR, PR, and SD cases after induction platinum doublet.
Key exclusion criteria
they had a concurrent malignancy, uncontrollable complications, severe morbidity; hypersensitivity to therapeutic agents; the possibility of being pregnant, and other conditions such as hepatic inflammation, as judged by the attending physician.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Fumihiro |
| Middle name | |
| Last name | Tanaka |
Organization
University of Occupational and Environmental Health
Division name
Second Department of Surgery
Zip code
8078555
Address
Iseigaoka, Yahatanishi-ku
TEL
0936917442
ftanaka@med.uoeh-u.ac.jp
Public contact
Name of contact person
| 1st name | Koji |
| Middle name | |
| Last name | Kuroda |
Organization
University of Occupational and Environmental Health
Division name
Second Department of Surgery
Zip code
8078555
Address
Iseigaoka, Yahatanishi-ku
TEL
0936917442
Homepage URL
kuroda-k@med.uoeh-u.ac.jp
Sponsor or person
Institute
University of Occupational and Environmental Health
Institute
Department
Personal name
Funding Source
Organization
University of Occupational and Environmental Health
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
University of Occupational and Environmental Health
Address
1-1 Iseigaoka, Yahatanishi-ku, Kitakyusyu
Tel
093-603-1611
fumi0914@med.uoeh-u.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
産業医科大学
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 06 | 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
11
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 | 06 | Month | 01 | Day |
Date of IRB
| 2011 | Year | 07 | Month | 06 | Day |
Anticipated trial start date
| 2011 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 07 | 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 | 06 | Month | 01 | Day |
Last modified on
| 2019 | Year | 06 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006741
| 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 |
