UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000005041
Receipt No. R000005993
Scientific Title The Feasibility Study of Adjuvant Chemotherapy with TS-1+Carboplatin followed by TS-1 maintenace in Patients with Completely Resected Stage II-IIIA Non-Small-Cell Lung Cancer
Date of disclosure of the study information 2011/02/07
Last modified on 2019/08/15 (Ver. 7)

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Basic information
Public title The Feasibility Study of Adjuvant Chemotherapy with TS-1+Carboplatin followed by TS-1 maintenace in Patients with Completely Resected Stage II-IIIA Non-Small-Cell Lung Cancer
Acronym The Feasibility Study of Adjuvant TS-1+ Carboplatin and TS-1 Maintenance in Patients with Resected Stage II-IIIA Non-Small-Cell Lung Cancer
Scientific Title The Feasibility Study of Adjuvant Chemotherapy with TS-1+Carboplatin followed by TS-1 maintenace in Patients with Completely Resected Stage II-IIIA Non-Small-Cell Lung Cancer
Scientific Title:Acronym The Feasibility Study of Adjuvant TS-1+ Carboplatin and TS-1 Maintenance in Patients with Resected Stage II-IIIA 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 evaluate the feasibility of TS-1+ Carboplatin followed by TS-1 Maintenance as adjuvant chemotherapy in patients with completely resected p-stage II-III non-small cell lung cancer
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase I

Assessment
Primary outcomes Feasibility
Key secondary outcomes 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 Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Carboplatin (5AUC) (day 1) +
S-1 (80mg/m2) (day 1-14)
q4weeks, 4 cycles
Maintenace S-1 (80mg/m2) (day 1-14)
q3weeks, 8 cycles

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
75 years-old >
Gender Male and Female
Key inclusion criteria 1. Histologically determined non-small cell lung cancer
2. Completely resected (more than lobectomy + ND2a)
3. Pathological stage IIA, IIB, IIIA
4. Neither previous chemotherapy nor radiotherapy before operation
5. Aged 20-74 years old
6. ECOG performance status 0 or 1
7. Adequate organ function
8. Possible to receive chemotherapy within 8 months after surgery
9. Written informed consent
Key exclusion criteria 1. Allergy against platinum-containing drugs or component of S-1
2. Severe complications
(i.e. ischemic heart diseases required treatment, arrhythmia, myocardial infarction within 6 months, uncontrolled diabetes, ileus, diarrhea, hemorrhagic tendency)
3. Active infections
4. Massive pleural or pericardial effusion
5. Active simultaneous cancer
6. Active interstitial pneumonitis or its past history
6. Pregnant or lactating women
8. Other conditions not suitable for this study
Target sample size 85

Research contact person
Name of lead principal investigator
1st name Hiroshi
Middle name
Last name Date
Organization Graduate School of Medicine, Kyoto University
Division name Thoracic Surgery
Zip code 606-8507
Address 54 Kawaharacho, Shogoin, Sakyo-ku, Kyoto, Kyoto 606-8507, Japan
TEL 075-751-3111
Email hdate@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person
1st name Shinichi
Middle name
Last name Toyooka
Organization Setouchi Lung Cancer Group
Division name Dept. of Thoracic, Breast & Endocrine Surgery, Okayama Univ. Grad. Sch. Med., Dent. & Pharma. Sci.
Zip code 700-8558
Address 2-5-1 Shikata-cho, Kita-ku, Okayama 700-8558 Japan
TEL 086-235-7265
Homepage URL
Email toyooka@md.okayama-u.ac.jp

Sponsor
Institute Setouchi Lung Cancer Group
Institute
Department

Funding Source
Organization None
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 Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences and Okayama University Hospital, Ethics Committee
Address 2-5-1 Shikata-cho, Kita-ku, Okayama 700-8558, Japan
Tel 086-235-6938
Email mae6605@adm.okayama-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

Other administrative information
Date of disclosure of the study information
2011 Year 02 Month 07 Day

Related information
URL releasing protocol https://www.ncbi.nlm.nih.gov/pubmed/27921177
Publication of results Published

Result
URL related to results and publications https://www.ncbi.nlm.nih.gov/pubmed/27921177
Number of participants that the trial has enrolled 89
Results 
Seventy-eight patients (89.7%) completed four cycles of S-1 plus carboplatin and 55 (63.2%) completed the following S-1 maintenance therapy for a total of 10 months. The treatment completion rate was 63.2% (90% CI, 54.4-71.2%), indicating feasibility. There were no treatment-related deaths. Grade 3/4 toxicities included neutropenia (13.8%), thrombocytopenia (11.5%), and anorexia (4.6%). The 2-year relapse-free survival rate was 59.8%.
Results date posted
2019 Year 08 Month 15 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics 
patients with completely resected stage II-IIIA non-small-cell lung cancer (NSCLC)
Participant flow 
Patients received four cycles of S-1 (80 mg/m2/day for 2 weeks, followed by 2 weeks rest) plus carboplatin (area under the curve 5, day 1) followed by S-1 (80 mg/m2/day for 2 weeks, followed by a 1-week rest).
Adverse events 
Grade 3/4 toxicities included neutropenia (13.8%), thrombocytopenia (11.5%), and anorexia (4.6%).
Outcome measures 
The treatment completion rate was 63.2% (90% CI, 54.4-71.2%). The 2-year relapse-free survival rate was 59.8%.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2011 Year 01 Month 25 Day
Date of IRB
2011 Year 01 Month 25 Day
Anticipated trial start date
2011 Year 01 Month 25 Day
Last follow-up date
2017 Year 03 Month 13 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 02 Month 06 Day
Last modified on
2019 Year 08 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000005993