UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009101 |
|---|---|
| Receipt number | 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 14:46:16 |
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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
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
mi@thoracic.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University Graduate School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010675
