UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001032 |
|---|---|
| Receipt number | R000001244 |
| Scientific Title | Phase II Study of Gemcitabine + S-1 in Elderly Patients With Non-Small Cell Lung Cancer |
| Date of disclosure of the study information | 2008/04/01 |
| Last modified on | 2010/09/30 12:06:15 |
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Basic information
Public title
Phase II Study of Gemcitabine + S-1 in Elderly Patients With Non-Small Cell Lung Cancer
Acronym
Phase II Study of Gemcitabine + S-1 in Elderly Patients With Non-Small Cell Lung Cancer
Scientific Title
Phase II Study of Gemcitabine + S-1 in Elderly Patients With Non-Small Cell Lung Cancer
Scientific Title:Acronym
Phase II Study of Gemcitabine + S-1 in Elderly Patients With Non-Small Cell Lung Cancer
Region
| Japan |
Condition
Condition
non-small cell lung cancer
Classification by specialty
| Pneumology | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To test the efficacy and tolerability of combination chemotherapy of gemcitabine plus S-1 as first-line chemotherapy in elderly patients with stage IIIB/IV 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
progression-free survival
Key secondary outcomes
compliance, safety, response rate, overall survival time
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
gemcitabine, S-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
| 75 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients must have histologically or cytologically confirmed non-small cell lung cancer that is inoperable or unsuitable for radical radiotherapy Stage IIIB or Stage IV. Recurrence after surgery is allowed.
2) Patient has measurable disease.
3) Patient has no prior chemotherapy. Patients who had received previous radiotherapy are included if their assessable disease is outside of the radiation field.
4) Patients must be greater than or equal to 75 years of age.
5) ECOG performance status 0 or 1
6) Laboratory values must be as follows;
WBC count greater than or equal to 4,000/mm3,absolute neutrophil count greater than or equal to 2,000/mm3, platelet count greater than or equal to 100,000/mm3, hemoglobin greater than or equal to 9.0g/dL, AST and ALT within twice the upper limit of normal for the institution,bilirubine level less than or equal to 1.5 mg/dL, serum creatinine within the upper limit of normal, or creatinine clearance greater than or equal to 60 mL/min, PaO2 greater than or equal to 60 torr
7) Estimated life expectancy 3 months
8) Patients must sign an informed consent.
Key exclusion criteria
1)No interstitial pneumonia or pulmonary fibrosis, as determined by chest x-ray
2)A history of severe allergic reactions to drugs
3) Patients with concurrent serious infections or complications are excluded
4) Clinically significant pleural/pericardial effusion which requires drainage before study entry.
5) Patients with an unstable or serious heart disease
6) Inadequately controlled diabetes mellitus
7) Symptomatic brain metastases
8) The presence of other concomitant or metachronous cancers
9)Any concomitant pathology that would, in the investigator`s opinion, contraindicate the use of the drugs in the protocol
Target sample size
35
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masaaki Kawahara |
Organization
National Hospital Organization Kinki-chuo Chest Medical Center
Division name
Internal Medicine
Zip code
Address
1180 Nagasone, Kitaku, Sakai, Osaka, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shinji Atagi |
Organization
National Hospital Organization Kinki-chuo Chest Medical Center
Division name
Internal Medicine
Zip code
Address
TEL
0722-52-3021
Homepage URL
Sponsor or person
Institute
National Hospital Organization Lung Cancer Study Group
Institute
Department
Personal name
Funding Source
Organization
National Hospital Organization Lung Cancer Study Group
Organization
Division
Category of Funding Organization
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 | 04 | Month | 01 | 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 | 01 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2010 | 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
| 2008 | Year | 02 | Month | 14 | Day |
Last modified on
| 2010 | Year | 09 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001244
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| Registered date | File name |
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