UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005993 |
|---|---|
| Receipt number | R000007088 |
| Scientific Title | A randomized phase II study of cisplatin+TS-1 versus cisplatin+docetaxel, with thoracic radiotherapy for locally advanced non-small cell lung cancer (TORG1018) |
| Date of disclosure of the study information | 2011/07/18 |
| Last modified on | 2015/01/26 21:14:38 |
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Basic information
Public title
A randomized phase II study of cisplatin+TS-1 versus cisplatin+docetaxel, with thoracic radiotherapy for locally advanced non-small cell lung cancer (TORG1018)
Acronym
A randomized phase II study of cisplatin+TS-1 versus cisplatin+docetaxel, with thoracic radiotherapy for locally advanced non-small cell lung cancer (TORG1018)
Scientific Title
A randomized phase II study of cisplatin+TS-1 versus cisplatin+docetaxel, with thoracic radiotherapy for locally advanced non-small cell lung cancer (TORG1018)
Scientific Title:Acronym
A randomized phase II study of cisplatin+TS-1 versus cisplatin+docetaxel, with thoracic radiotherapy for locally advanced non-small cell lung cancer (TORG1018)
Region
| Japan |
Condition
Condition
Non-small cell lung cancer
Classification by specialty
| Pneumology | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate efficacy and safety of cisplatin+TS-1 or cisplatin+docetaxel, with thoracic radiotherapy for locally advanced non-small cell lung cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
2 year survival rate
Key secondary outcomes
over all survival, progression free survival, adverse events, dose intensity
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
cisplatin+TS-1+thoracic radiotherapy
Interventions/Control_2
cisplatin+docetaxel+thoracic radiotherapy
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 or cytologically confirmed NSCLC
2)stage III NSCLC with no prior chemotherapy, radiotherapy or surgery (open biopsy is allowed)
3)unresectable lung cancer
4)V20 <=95% or equivalent dose to it
5)oral intake is possible
6)aged 20 years or older, under 75 years
7)ECOG PS 0-1
8)adequate organ function
-WBC count >=4000/mm3
-neutrophil count >=2000/mm3
-hemoglobin >=9.5g/dL
-platelet count >=100000/mm3
-AST and ALT <=100IU/L
-total bilirubine level <=1.5mg/dL
-serum creatinine <=1.5mg/dL
-creatinine clearance >=60mL/min
-PaO2 >=70torr
9)written informed consent
Key exclusion criteria
1)T3N1
2)SVC syndrome with difficulty of a lot of intravenous infusion
3)clinically significant contralateral hilar lymph node metastasis, carcinomatous pericardial or pleural effusion, or carcinomatous lymphangitis
4)concurent serious infection or complications
5)continuous watery diarrhea
6)significant interstitial pneumonitis or pulmonary fibrosis in chest CT
7)concomitant cancers within 5 years
8)concomitant therapy with another new anticancer drug, phenytoin, warfarin or flucytocine
9)inadequately controlled diabetes mellitus
10)HBs Ag is positive
11)a history of serious drug allergy
12)mental disease or psychotic manifestation
13)pregnancy, breast feeding, wish of future bearing or hesitation in contraception
14)other conditions not suitable for this study
Target sample size
110
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroaki Okamoto |
Organization
Yokohama Municipal Citizen's Hospital
Division name
Department of Respiratory Medicine
Zip code
Address
56, Okazawa-cho, Hodogaya-ku, Yokohama-shi, Kanagawa, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tsuneo Shimokawa |
Organization
Yokohama Municipal Citizen's Hospital
Division name
Department of Respiratory Medicine
Zip code
Address
56, Okazawa-cho, Hodogaya-ku, Yokohama-shi, Kanagawa, Japan
TEL
Homepage URL
http://www.torg.or.jp/
ts00-shimokawa@city.yokohama.jp
Sponsor or person
Institute
Thoracic Oncology Research Group
Institute
Department
Personal name
Funding Source
Organization
Thoracic Oncology Research Group
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
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
| 2011 | Year | 07 | 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
No longer recruiting
Date of protocol fixation
| 2011 | Year | 05 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 07 | 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 | 07 | Month | 18 | Day |
Last modified on
| 2015 | Year | 01 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007088
