UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001049 |
|---|---|
| Receipt number | R000001255 |
| Scientific Title | Adjuvant chemotherapy for completely rsected non-small cell lung cancer with TS-1 - evaluation of predictive factors for prognosis |
| Date of disclosure of the study information | 2008/02/22 |
| Last modified on | 2020/09/08 16:03:29 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Adjuvant chemotherapy for completely rsected non-small cell lung cancer with TS-1 - evaluation of predictive factors for prognosis
Acronym
KOLK-2
Scientific Title
Adjuvant chemotherapy for completely rsected non-small cell lung cancer with TS-1 - evaluation of predictive factors for prognosis
Scientific Title:Acronym
KOLK-2
Region
| Japan |
Condition
Condition
completely resected non-small cell lung cancer
Classification by specialty
| Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To identify the predictive factors for TS-1 sensitivity as adjuvant chemotherapy
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
To identify the predictive factors for TS-1 sensitivity as adjuvant chemotherapy
Key secondary outcomes
Feasibility and safety
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
TS-1 (80-120mg/day x 14days, q21d X 16 courses) is administrated orally.
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
1) completely resected NSCLC
2) Ad, Sq, Large, AdSq
3) p-Stage IA (>=2.0cm), p-Stage IB
4) age ranged from 20 to 80
5) PS 0-1 (ECOG)
6) sufficient functionn of important organs
a) WBC >= 4000/mm3
b) Neutro >= 2000/mm3
c) Platelet >= 100,000/mm3
d) Hb >= 9.0g/dl
e) AST/ALT <= 2.5 fold of normal ranges in each institute
f) T.Bil <= 1.5mg/dl
g) Cr <= within normal limit
h) CCr >= 50ml/min
i) PaO2 >=70torr or SpO2>=92%
7) administration of TS-1 within 8 weeks after surgery
8) without previous treatment
9) with ability of oral intake
10) with written informed consent
Key exclusion criteria
1) with interstitial change or fobrotic change on chest X ray film or chest CT scan
2) massive pleural effusion or ascites
3) with active double cancer
4) with intractable angina pectoris, myocardial infarction, cardiac failure, intractable diabetes mellitus, hypertension, sever infection, ileus, SVC syndrome, abnormal coagulability
5) watery diarrhea
6) pregnant, nursing woman or woman who is likely to be pregnant
7) men with partner willing to get pregnant
8) with severe drug allergy
9) with hypersensitivity to elements of TS-1
10) under medication with 5-FU
11) under medication with Flucytocine
12) doctor's decision not to be registered to this study
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroaki Nomori |
Organization
Keio University, School of Medicine
Division name
Division of General Thoracic Surgery
Zip code
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mitsutomo Kono |
Organization
Keio University, School of Medicine
Division name
Division of General Thoracic Surgery
Zip code
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
03-5363-3806
Homepage URL
kohno@1993.jukuin.keio.ac.jp
Sponsor or person
Institute
Division of General Thoracic Surgery,
Keio University, School of Medicine,
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
Address
Tel
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
| 2008 | Year | 02 | Month | 22 | 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
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
| 2008 | Year | 02 | Month | 19 | Day |
Date of IRB
| 2008 | Year | 02 | Month | 19 | Day |
Anticipated trial start date
| 2008 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 10 | 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
| 2008 | Year | 02 | Month | 22 | Day |
Last modified on
| 2020 | Year | 09 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001255
