UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005389 |
|---|---|
| Receipt number | R000006398 |
| Scientific Title | Phase I/ II study of S-1 and cisplatin with concurrent radiotherapy for locally advanced non-small-cell lung cancer. |
| Date of disclosure of the study information | 2011/04/06 |
| Last modified on | 2011/04/06 16:25:23 |
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Basic information
Public title
Phase I/ II study of S-1 and cisplatin with concurrent radiotherapy for locally advanced non-small-cell lung cancer.
Acronym
S-1 and cisplatin with concurrent radiotherapy for NSCLC.
Scientific Title
Phase I/ II study of S-1 and cisplatin with concurrent radiotherapy for locally advanced non-small-cell lung cancer.
Scientific Title:Acronym
S-1 and cisplatin with concurrent radiotherapy for NSCLC.
Region
| Japan |
Condition
Condition
Lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the feasibility and efficacy of S-1 and cisplatin with concurrent thoracic radiation for unresectable stage III non-small-cell lung cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase I,II
Assessment
Primary outcomes
2-year survival rate
Key secondary outcomes
objective response rate,overall survival,progression-free survival,toxicity
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
Level 1;
CDDP 60 mg/m2, day 8
S-1 80 mg/m2 days 1-14 every 3weeks
Level 2;
CDDP 60 mg/m2, day 8
S-1 80 mg/m2 days 1-21 every 4weeks
Thoracic radiation 60Gy/30fr
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
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Eligibility criteria were: histological or cytological diagnosis of unresectable stage III NSCLC; no prior chemotherapy; measurable lesions; PS (ECOG) 0-1; adequate hematology and biochemistry parameters; and informed consent.
Key exclusion criteria
Exclusion criteria were:active concomitant malignancy; active pulmonary fibrosis or interstitial pneumonia ; watery diarrhea; serious complications; pregnancy; psychotic disorder; and drug allergy.
Target sample size
45
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kiyotaka Yoh |
Organization
National Cancer Center Hospital East
Division name
Division of Thoracic Oncology
Zip code
Address
6-5-1,Kashiwanoha,Kashiwa-shi,Chiba-ken,277-8577
TEL
04-7133-1111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tetsuhiko Taira |
Organization
National Cancer Center Hospital East
Division name
Division of Thoracic Oncology
Zip code
Address
6-5-1,Kashiwanoha,Kashiwa-shi,Chiba-ken,277-8577
TEL
Homepage URL
Sponsor or person
Institute
National Cancer Center Hospital East
Institute
Department
Personal name
Funding Source
Organization
National Cancer Center Hospital East
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
国立がん研究センター東病院
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 04 | Month | 06 | 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
| 2005 | Year | 07 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2005 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 08 | 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
| 2011 | Year | 04 | Month | 06 | Day |
Last modified on
| 2011 | Year | 04 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006398
