UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003986 |
|---|---|
| Receipt number | R000004750 |
| Scientific Title | Phase II study of S-1 for non-small lung cancer after failure of two or three prior chemotherapy regimens |
| Date of disclosure of the study information | 2010/08/04 |
| Last modified on | 2016/08/07 10:36:16 |
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Basic information
Public title
Phase II study of S-1 for non-small lung cancer after failure of two or three prior chemotherapy regimens
Acronym
Phase II study of 3rd-line S-1 for NSCLC
Scientific Title
Phase II study of S-1 for non-small lung cancer after failure of two or three prior chemotherapy regimens
Scientific Title:Acronym
Phase II study of 3rd-line S-1 for NSCLC
Region
| Japan |
Condition
Condition
Non Small Cell Lung Cancer (NSCLC)
Classification by specialty
| Pneumology | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this phase II trial is to evaluate the safety and efficacy of single S-1 administration as a third-line chemotherapy for non-small cell carcinoma.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Disease control rate by CT scan and physical exam at the end of every even course or every 4 weeks until progressive disease (PD) or initiation of new anticancer therapy
Key secondary outcomes
Overall survival every 2 months after PD for up to 12 months following the end of patient accrual
Duration of response by CT scan and physical exam at the end of every even course or every 4 weeks until
PD or initiation of new anticancer therapy
Progression-free survival by CT scan and physical exam every 4 weeks
Safety by laboratory evaluations and assessment of adverse events on days 1, 8, and 15 of every course, EOS, periodically, and 30 days after treatment
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
Patients receive oral S-1 twice daily on days 1-14. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 4 weeks until progressive disease and then every 2 months thereafter.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Histologically and/or cytologically proven non-small cell carcinoma.
2.Prior chemotherapy with more than two regimens, necessarily including at least one platinum-based (CDDP or CBDCA) combination. Use of molecular-targeting drugs and adjuvant therapy are countable to the prior regimens. Prior concurrent therapies including endocrine therapy, surgery, and radiotherapy are acceptable for the inclusion.
3.The presence of measurable disease.
4.An ECOG performance status ranging from 0 to 2.
5.Aged greater than 20 year-old.
6.Major organs are in normal conditions.
White blood cell count => 3000/mm3
Absolute granulocyte count => 1500/mm3
Hemoglobin => 9.0g/dL
Platelet count => 100,000/mm3
Serum bilirubin <= 1.8 mg/dL or 1.5 times upper limit of normal
AST, ALT <= 2 times upper limit of normal
Serum creatinine <= 1.5 mg/dL
Oxyhemoglobin satulation (SpO2) => 90%
7.Life expectancy should exceed at least 3 months.
8.All participants have given written informed consent.
Key exclusion criteria
1. Previous histories of drug allergy, which may increase the risk of this study.
2. Serious concomitant infection or high-grade fever exceeding 38 deg C or more.
3. Usages of oral steroids or immunosuppressive drugs.
4. Serious complications including severe cardiovascular disease, cerebrovascular disease, severe hypertension, active peptic ulcer, uncontrolled diabetes.
5. Interstitial pneumonia or pulmonary fibrosis on chest X-ray or CT scans.
6. Any prior treatments with S-1 or UFT.
7. Any coelomic fluids (pleural, pericardial, or ascites), which require emergent treatment.
8. Symptomatic brain metastases.
9. Other active multiple cancers.
10. Severe heart diseases.
11. Psychiatric conditions, which may increase the risks associated with the study participation.
12. Pregnant or nursing women.
13. Other conditions, on which the judgment of the investigator would make the patient inappropriate for entry.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yutaka Nishigaki |
Organization
National Hospital Organization Asahikawa Medical Center
Division name
Department of Clinical Research
Zip code
Address
7-4048, Hanasaki-cho, Asahikawa 070-8644, Japan
TEL
0166.51.3161
yutakan@asahikawa.hosp.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yutaka Nishigaki |
Organization
National Hospital Organization Asahikawa Medical Center
Division name
Department of Clinical Research
Zip code
Address
7-4048, Hanasaki-cho, Asahikawa 070-8644, Japan
TEL
0166.51.3161
Homepage URL
yutakan@asahikawa.hosp.go.jp
Sponsor or person
Institute
National Hospital Organization Asahikawa Medical Cencer
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
国立病院機構旭川医療センター
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 08 | Month | 04 | 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
Terminated
Date of protocol fixation
| 2010 | Year | 07 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 08 | 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
| 2010 | Year | 08 | Month | 03 | Day |
Last modified on
| 2016 | Year | 08 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004750
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