UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000132 |
|---|---|
| Receipt number | R000000194 |
| Scientific Title | Phase I study of S-1 with concurrent thoracic radiation therapy for elderly inoperable locally advanced non-small-cell lung cancer |
| Date of disclosure of the study information | 2005/09/12 |
| Last modified on | 2015/01/08 18:16:05 |
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Basic information
Public title
Phase I study of S-1 with concurrent thoracic radiation therapy for elderly inoperable locally advanced non-small-cell lung cancer
Acronym
S-1 with radiotherapy for elderly locally advanced non-small-cell lung cancer
Scientific Title
Phase I study of S-1 with concurrent thoracic radiation therapy for elderly inoperable locally advanced non-small-cell lung cancer
Scientific Title:Acronym
S-1 with radiotherapy for elderly locally advanced non-small-cell lung cancer
Region
| Japan |
Condition
Condition
Elderly inoperable locally advanced non-small-cell lung cancer
Classification by specialty
| Pneumology | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The objective is to determine the maximum-tolerated doses and the recommended dose of S-1 when combined with concurrent thoracic radiotherapy.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase I
Assessment
Primary outcomes
maximum-tolerated doses and the recommended dose for phase II
Key secondary outcomes
response rate
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
S-1 with concurrent thoracic radiation therapy
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
| 76 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Histologically and/or cytologically proven NSCLC
No prior surgery, chemotherapy, or radiotherapy
Age > 75
Unresectable stage IIIA or IIIB
ECOG performance status 0 or 1
Measurable disease
Ample bone marrow, lung, hepatic, and renal function
Signed informed consent
Key exclusion criteria
Involvement of contralateral hilar node, dissemination to pleura/pericardium, or malignant pleural/pericardial effusion
Active concomitant malignancy
History of chemotherapy or thoracic radiotherapy for previous malignancy
Interstitial pneumonia
Unstable angina, recent myocardial infarction
Uncontrolled diabetes
Severe active infection
Other severe complications
Judging of inappropriate condition for this study by physician.
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mitsune Tanimoto |
Organization
Okayama University Hospital
Division name
Hematology, Oncology, Respiratory Medicine
Zip code
Address
2-5-1 Shikata-cho, Okayama 700-8558
TEL
086-235-7227
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Nagio Takigawa |
Organization
Okayama Lung Cancer Study Group Coordinating Office
Division name
Department of Respiratory Medicine, Okayama University Hospital
Zip code
Address
2-5-1 Shikata-cho, Okayama 700-8558
TEL
086-235-7227
Homepage URL
ntakigaw@md.okayama-u.ac.jp
Sponsor or person
Institute
Okayama Lung Cancer Study 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
| 2005 | Year | 09 | Month | 12 | 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
| 2005 | Year | 08 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2005 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 12 | 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
| 2005 | Year | 09 | Month | 08 | Day |
Last modified on
| 2015 | Year | 01 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000194
