UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006967 |
|---|---|
| Receipt number | R000008213 |
| Scientific Title | Phase I Study of adjuvant chemotherapy for the patients resected pathological stage IA(T1>2cm) Non Small Cell Lung Cancer (SLCG0701) |
| Date of disclosure of the study information | 2011/12/27 |
| Last modified on | 2019/05/03 21:45:58 |
* 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
Phase I Study of adjuvant chemotherapy for the patients resected pathological stage IA(T1>2cm) Non Small Cell Lung Cancer (SLCG0701)
Acronym
TS-1 for p-stage IA NSCLC(SLCG0701)
Scientific Title
Phase I Study of adjuvant chemotherapy for the patients resected pathological stage IA(T1>2cm) Non Small Cell Lung Cancer (SLCG0701)
Scientific Title:Acronym
TS-1 for p-stage IA NSCLC(SLCG0701)
Region
| Japan |
Condition
Condition
Non Small Cell Lung Cancer
Classification by specialty
| Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
to assess the efficacy and toxicity of two modified medication of S-1 adjuvant therapy for completely resected pathological stage IA (T1>2cm) non-small cell lung cancer.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
drug compliance
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
A:TS-1 day1-28, q2w for one year
Interventions/Control_2
A:TS-1 day1-14, q1w for one year
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) pathologically proven Non Small Cell Lung Cancer
2) complete resection
3) pathological stage IA (T1>2cm)
4) at least lobectomy, within 4 to 6 weaks after surgery
5) LN dissection (ND2a)
6) no prior anti cancer treatment for thoracic malignancy except for this operation
7) ECOG PS 0-1
8) adequate organ function
9) oral intake
10) Signed informed consent
Key exclusion criteria
1. sever infection, uncontrolled Diabetes Mellitus, and hypertension
2. unstable angina or Myocardial Infarction within 6 months
3. apparent interstitial pneumonitis at chest rentogenogram
4. systemic steroid therapy required
5. uncontrolled cancer
6. Pregnant or expecting woman
7. serious psychiatric illness
8. usaige of other fluorinated pyrimidine drugs
9. Concomitant therapy with flucytocine, phenytoin or Warfarin Potassium
Target sample size
80
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 Kawara-machi Seigoin Sakyoku, Kyoto, Kyoto 606-8507, Japan
TEL
0757513111
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
Okayama University, Cancer and Thoracic Surgery
Zip code
700-8558
Address
2-5-1 Shikata-cho Kita-ku Okayama
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 IRB
Address
2-5-1 Shikata-cho Okayama, Okayama 700-8558, Japan
Tel
086-235-6762
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 | 12 | Month | 27 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2007 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 06 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 12 | Month | 27 | Day |
Last modified on
| 2019 | Year | 05 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008213
