UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001510 |
|---|---|
| Receipt number | R000001814 |
| Scientific Title | A phase II randomized trial in completely resected non-small cell lung cancer comparing paclitaxel / carboplatin with TS-1 |
| Date of disclosure of the study information | 2008/11/18 |
| Last modified on | 2012/11/18 23:01:21 |
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Basic information
Public title
A phase II randomized trial in completely resected non-small cell lung cancer comparing paclitaxel / carboplatin with TS-1
Acronym
A phase II randomized trial in completely resected non-small cell lung cancer (PTX/CBDCA vs TS-1)
Scientific Title
A phase II randomized trial in completely resected non-small cell lung cancer comparing paclitaxel / carboplatin with TS-1
Scientific Title:Acronym
A phase II randomized trial in completely resected non-small cell lung cancer (PTX/CBDCA vs TS-1)
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 compare the efficacy of adjuvant chemotherapy with PTX/CBDCA and TS-1 for completely resected non-small cell lung cancer in stage II and IIIA
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
2-year relapse free survival
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
A: paclitaxel 120mg/m2 + carboplatin AUC 3, day1 and day15, q4w, 4 course
Interventions/Control_2
B: TS-1 80mg/m2 oral, day1 to 14, q3w, 1 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
| 20 | years-old | <= |
Age-upper limit
| 76 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) pathologically proven non-small cell lung cancer
2) completely resected by lobectomy or pneumonectomy (+ other resection)
3) pathological stage II or IIIA (IASCL ver.7)
4) no prior chemotherapy or radiotherapy
5) PS 0 or 1
6) age 20-75
7) adequate organ function
.WBC>=3500/mm3<=12000/mm3
.neutrophil<=2000/mm3
.platelet<=100000/mm3
.AST,ALT within 2 times of upper limit
.total bilirubin within 2 times of upper limit
.SpO2>=95%
.creatinin within upper limit
.creatinin clearance>=60ml/min/body
8) possible to receive chemotherapy within 8 weeks after surgery
9) oral intake possible
10) written informed consent
Key exclusion criteria
1) apparent interstitial pneumonitis or pulmonary fibrosis
2) uncontroled pleural effusion or ascitis
3) multiple lung cancer
4) concomittant malignanct
5) past history of radiotherapy or chemotherapy
6) active infection or uncontroled complication
7) past history of severe allergic reaction
8) Pregnant or expecting woman
9) other conditions not suitable for this study
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Motoki Yano |
Organization
Nagoya City University Hospital
Division name
Department of thoracic Surgery
Zip code
Address
1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Motoki Yano |
Organization
Nagoya City University Graduate school of Medical Sciences
Division name
Department of Oncology, Immunology, and Surgery
Zip code
Address
TEL
Homepage URL
Sponsor or person
Institute
Nagoya City University thoracic oncology study group
Institute
Department
Personal name
Funding Source
Organization
Nagoya City University Graduate school of Medical Sciences
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 | 11 | Month | 18 | 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
Date of protocol fixation
| 2008 | Year | 11 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2013 | 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 | 11 | Month | 18 | Day |
Last modified on
| 2012 | Year | 11 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001814
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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