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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000009101
Receipt No. R000010675
Scientific Title Feasibility study of CBDCA+TS-1 adjuvant therapy for p-stage IB(T2a>4cm)/II/IIIA non-small cell lung cancer
Date of disclosure of the study information 2012/10/12
Last modified on 2020/10/19

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Basic information
Public title Feasibility study of CBDCA+TS-1 adjuvant therapy for p-stage IB(T2a>4cm)/II/IIIA non-small cell lung cancer
Acronym Feasibility study of CBDCA+TS-1 adjuvant therapy for non-small cell lung cancer
Scientific Title Feasibility study of CBDCA+TS-1 adjuvant therapy for p-stage IB(T2a>4cm)/II/IIIA non-small cell lung cancer
Scientific Title:Acronym Feasibility study of CBDCA+TS-1 adjuvant therapy for non-small cell lung cancer
Region
Japan

Condition
Condition non-small cell lung cancer
Classification by specialty
Pneumology Chest surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To investigate safety and feasibility of CBDCA+TS-1 adjuvant therapy for p-stage IB(T2a>4cm)/II/IIIA non-small cell lung cancer.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Accomplishment of 4 course treatment
Key secondary outcomes safety, 2-year disease free survival, overall survival

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 carcinostatics CBDCA, TS-1
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 p-stage IB(T2a>4cm)/II/IIIA non-small cell lung cancer
complete resection with more than lobectomy
PS 0-1
preserved bone marrow, liver, renal, lung function
Key exclusion criteria Allergy for CBDCA/TS-1
Myocardial infarction within 6 months
Interstitial pneumonia
sever heart disease
significant psychological disease
uncontrollable diabetes mellitus
Target sample size 35

Research contact person
Name of lead principal investigator
1st name Masayoshi
Middle name
Last name Inoue
Organization Osaka University Graduate School of Medicine
Division name Department of General Thoracic Surgery
Zip code 5650871
Address 2-2 Yamadaoka, Suita-city, Osaka
TEL 06-6879-3152
Email mi@thoracic.med.osaka-u.ac.jp

Public contact
Name of contact person
1st name Masayoshi
Middle name
Last name Inoue
Organization Osaka University Graduate School of Medicine
Division name Department of General Thoracic Surgery
Zip code 5650871
Address 2-2 Yamadaoka, Suita-city, Osaka
TEL 06-6879-3152
Homepage URL
Email mi@thoracic.med.osaka-u.ac.jp

Sponsor
Institute Osaka University Graduate School of Medicine
Institute
Department

Funding Source
Organization self
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 Osaka University Institutional Review Board
Address 2-15 Yamadaika Suita Osaka
Tel 06-6879-5685
Email rinri@hp-crc.med.osaka-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 大阪大学医学部附属病院、大阪警察病院、国立病院機構刀根山病院、近畿大学医学部奈良病院

Other administrative information
Date of disclosure of the study information
2012 Year 10 Month 12 Day

Related information
URL releasing protocol https://pubmed.ncbi.nlm.nih.gov/31409216/
Publication of results Published

Result
URL related to results and publications https://pubmed.ncbi.nlm.nih.gov/31409216/
Number of participants that the trial has enrolled 35
Results The adjuvant chemotherapy completion rate was 85.3% (29/34); 17/34 (50%) patients completed 4 courses without dose reduction. There were no treatment-related deaths, and Grade 3/4 adverse events included neutropenia (38.2%), leukocytopenia (14.7%), anemia (20.6%), thrombocytopenia (20.6%), anorexia (5.9%), fatigue (5.9%), and oral mucositis (2.9%). Two-year overall and disease-free survival rates were 96.3% and 53.3%, respectively. Adjuvant chemotherapy with carboplatin plus S-1 is safe and feasible.
Results date posted
2020 Year 10 Month 19 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics patients with completely resected non-small cell lung cancer
Participant flow A phase II clinical trial of adjuvant chemotherapy with four courses of carboplatin (AUC 5 at day 1) and S-1 (80 mg/m2/day for 2 weeks followed by a 2-week rest)
Adverse events Grade 3/4 adverse events included neutropenia (38.2%), leukocytopenia (14.7%), anemia (20.6%), thrombocytopenia (20.6%), anorexia (5.9%), fatigue (5.9%), and oral mucositis (2.9%).
Outcome measures The primary endpoint was the completion rate and the secondary endpoints were adverse events, 2-year overall survival and disease-free rates.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Main results already published
Date of protocol fixation
2012 Year 02 Month 01 Day
Date of IRB
2011 Year 12 Month 06 Day
Anticipated trial start date
2012 Year 02 Month 01 Day
Last follow-up date
2019 Year 07 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2012 Year 10 Month 12 Day
Last modified on
2020 Year 10 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010675

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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