UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001370 |
|---|---|
| Receipt number | R000001666 |
| Scientific Title | A Phase II Study of Combination Chemotherapy using TS-1 and Cisplatin with Concurrent Thoracic Radiotherapy for Locally Advanced Non-Small Cell Lung Cancer |
| Date of disclosure of the study information | 2008/09/12 |
| Last modified on | 2015/08/31 16:12:40 |
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Basic information
Public title
A Phase II Study of Combination Chemotherapy using TS-1 and Cisplatin with Concurrent Thoracic Radiotherapy for Locally Advanced Non-Small Cell Lung Cancer
Acronym
Cis/TS-1 radiation
Scientific Title
A Phase II Study of Combination Chemotherapy using TS-1 and Cisplatin with Concurrent Thoracic Radiotherapy for Locally Advanced Non-Small Cell Lung Cancer
Scientific Title:Acronym
Cis/TS-1 radiation
Region
| Japan |
Condition
Condition
Locally Advanced Non-Small Cell Lung Cancer
Classification by specialty
| Pneumology | Hematology and clinical oncology | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To assess the efficacy and safety of Cisplatin+TS-1 with concurrent Thoracic radiotherapy for locally advanced non-small cell lung cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Response rate
Key secondary outcomes
Toxicity, overall survival, progression free survival, the rate of treatment success, The comparison of monitor units at the reference points with or without inhomogeneity corrections.
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
Cisplatin+TS-1
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
| Not applicable |
Age-upper limit
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1.Histologicaly or cytologicaly proven NSCLC
2.Un-treated patients with measurable (more than 10mm by CT or MRI) IIIA/IIIB NSCLC.
3.the case can eat.
4.When radio-oncologist judged that the patients can tolerable for full dose irradiation.
5.age under than 75
6.PS (ECOG) 0 to 1
7.Organ functions are met for this study.
8.WBC:4000/mm3
9.Neut: 2,000/mm3
10.Hb: 9.5 g/dl
11.PLT: 100,000/mm3
12.AST,ALT: 100 IU/L
13.T-bil: 1.5 mg/dL
14.Crea: 1.2 mg/dL
15.(Cockcroft-Gault):60 mL/min
16.PaO2: 70 torr
17.with written informed consent from patients.
Key exclusion criteria
1.with Superior vena cava syndrome
2.with sever allergy
3.on going other studies or treating with uncomfortable drugs to TS-1 and cisplatin
4.contra hilar lymph nod swelling, pleural or cardiac effusion dew to cancer, lymphangitis carcinomatoses, T3N1M0
5.with sever infection, bleeding, cardiac diseases.
6.with continues diarrhea
7.ileus or sub-ireus
8.with interstitial pneumonia, sever COPD
9.Presence of other active malignancy
10.un-controlled DM
11.Uncontrolled psychiatric disease.
12.pregnancy or lactating patients
13.Others
Target sample size
55
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takashi Seto |
Organization
National Kyushu Cancer Center
Division name
Thoracic Oncology
Zip code
Address
3-1-1 Notame Minami-ku Fukuoka City 811-1395, Japan
TEL
092-541-3231
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shinichiro Nakamura |
Organization
West Japan Oncology Group
Division name
WJOG datacenter
Zip code
Address
Namba Plaza Bldg.3F 1-5-7,Motomachi Naniwa-ku,Osaka556-0016 JAPAN
TEL
06-6633-7400
Homepage URL
datacenter@wjog.jp
Sponsor or person
Institute
West Japan Oncology 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
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 | 09 | Month | 12 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://www.ncbi.nlm.nih.gov/pubmed?term=22052226
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
| 2006 | Year | 09 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2006 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 04 | 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 | 09 | Month | 12 | Day |
Last modified on
| 2015 | Year | 08 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001666
