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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000011370
Receipt No. 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

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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
Email 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
Email hidemisuzukidesu@yahoo.co.jp

Sponsor
Institute Chiba University Graduate School of Medicine
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013304

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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