UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011370 |
|---|---|
| Receipt number | R000013304 |
| Scientific Title | Phase II study of alternate-day treatment with S-1 as adjuvant chemotherapy for patients with lung cancer. |
| Date of disclosure of the study information | 2013/08/05 |
| Last modified on | 2019/03/28 13:53:42 |
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Basic information
Public title
Phase II study of alternate-day treatment with S-1 as adjuvant chemotherapy for patients with lung cancer.
Acronym
Phase II study of alternate-day treatment with S-1 as adjuvant chemotherapy for patients with lung cancer.
Scientific Title
Phase II study of alternate-day treatment with S-1 as adjuvant chemotherapy for patients with lung cancer.
Scientific Title:Acronym
Phase II study of alternate-day treatment with S-1 as adjuvant chemotherapy for patients with lung cancer.
Region
| Japan |
Condition
Condition
lung cancer
Classification by specialty
| Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
A phase II study, that alternate-day S-1 is administered to patients with lung cancer,postoperatively, is carried out to confirm the feasibility,effectiveness and safety of the treatment.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
The ratio of the patients who completed the course
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
Adjuvant treatment of S-1 is administered on alternate-day for 1 year after surgery.
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 non-small cell lung cancer with stage IB to IIIA
2. curative resection (R0) at the prior surgery
3.without any prior radiation therapy, chemotherapy for primary lung cancer.
4. age: 20< years old
5. PS(ECOG): 0 or 1
6. without any other severe diseases
WBC 3,000<= and => 12,000/mm3
Platelet 100,000/mm3 <=
Hemoglobin 9.0 g.dl <=
Total bilirubin 1.5 mg/dl =>
AST, ALT 100 IU/L <=
SPO2 90% <= or PaO2 60mmHg <=
Creatinin clearance 40 ml/min/body <=
**Cockcroft-Gault method is available
7.patients who can start adjuvant treatment within 8 weeks postoperatively.
8. written informed consents
Key exclusion criteria
1) patients who cannot take S-1
1.with severe allergic history against the ingredients of S-1.
2. with sever bone marrow suppression, renal or liver dysfunction
3. patients who need other fluorouracil
4. patients who need flucitosine.
2) with severe allergic history against medicines
3) with history of myocardial infarction in 6 months.
4)with other severe diseases (cardiac failure,mental disorder, infection or other severe complications)
5) with uncontrolled DM
6) with watery diarrhea
7) with double cancer and or multiple cancer
8)doctors' stop not to register to the study
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | Ichiro |
| Middle name | |
| Last name | Yoshino |
Organization
Chiba University Graduate School of Medicine
Division name
Department of General Thoracic Surgery
Zip code
260-8670
Address
1-8-1, Inohana, Chiba, 260-8670, Japan
TEL
043-222-7171
iyoshino@faculty.chiba-u.jp
Public contact
Name of contact person
| 1st name | Hidemi |
| Middle name | |
| Last name | Suzuki |
Organization
Chiba University Graduate School of Medicine
Division name
Department of General Thoracic Surgery
Zip code
260-8670
Address
1-8-1, Inohana, Chiba, 260-8670, Japan
TEL
043-222-7171
Homepage URL
hidemisuzukidesu@yahoo.co.jp
Sponsor or person
Institute
Chiba University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Chiba University Graduate School of Medicine
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
Chiba University Hospital Clinical Research Center
Address
1-8-1, Inohana, Chiba, 260-8670, Japan
Tel
043-226-2616
prc-jim@chiba-u.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
| 2013 | Year | 08 | Month | 05 | 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
25
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
| 2013 | Year | 03 | Month | 25 | 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 | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 08 | Month | 04 | Day |
Last modified on
| 2019 | Year | 03 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013304
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| Registered date | File name |
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