UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005041 |
|---|---|
| Receipt number | 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 16:52:12 |
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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
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
toyooka@md.okayama-u.ac.jp
Sponsor or person
Institute
Setouchi Lung Cancer Group
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005993
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| Registered date | File name |
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