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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000003986
Receipt No. 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

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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
Email 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
Email yutakan@asahikawa.hosp.go.jp

Sponsor
Institute National Hospital Organization Asahikawa Medical Cencer
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004750

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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