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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000005308
Receipt No. R000006313
Scientific Title Randomized phase II study of Erlotinib vs. S-1 for non-small lung cancer after failure of two or three prior
Date of disclosure of the study information 2011/03/25
Last modified on 2016/04/27

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Basic information
Public title Randomized phase II study of Erlotinib vs. S-1 for non-small lung cancer after failure of two or three prior
Acronym Randomized phase II study of Erlotinib vs. S-1 for non-small lung cancer after failure of two or three prior
Scientific Title Randomized phase II study of Erlotinib vs. S-1 for non-small lung cancer after failure of two or three prior
Scientific Title:Acronym Randomized phase II study of Erlotinib vs. S-1 for non-small lung cancer after failure of two or three prior
Region
Japan

Condition
Condition Non-small-cell lung cancer
Classification by specialty
Pneumology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy and safety of Erlotinib or S-1 as 3rd or 4th-line Chemotherapy for patients with non-small-cell lung cancer.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Disease control rate
Key secondary outcomes Overall survival
Progression free survival
Response rate
Safty

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 S-1
Interventions/Control_2 Erlotinib
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 1)In 20-74 years of age at the time of consent.
2)Histologically or cytrologically confirmed diagnosis of non-small cell lung cancer.
3)Prior chemotherapy with more than two regimens, including at least one platinum-based (CDDP or CBDCA) combination. Use of molecular-targeting drugs and adjuvant therapy are not countable to the prior regimens. Prior concurrent therapies including endocrine therapy, surgery, and radiotherapy are acceptable for the inclusion.
4)Patients who have measurable lesion.
5)Eastern Cooperative Oncology Group(ECOG)Performance status 0-2.
6)Sufficient function of main organ( bone marrow,lung,liver,renal,heart)filled the following criteria.
White blood cell count>=3000/mm3
Absolute granulocyte count >= 1500/mm3
Hemoglobin >= 9.0g/dL
Platelet count >= 100,000/mm3
Serum bilirubin <= 1.5 mg/dL
AST,ALT <100 IU/l
Serum creatmine < 1.2 mg/dL or Ccr>=60ml/min PaO2(Room air) >=60Torr
(or SpO2>=95%)
7)Life expectancy more than 3 months.
8)Written informed consent
Key exclusion criteria 1)Previous histories of drug allergy, which may increase the risk of this study.
2)Serious concomitant infection.
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 CT scans.
6)Patients with EGFR mutation or having past history of administration of EGFR tyrosine kinase inhibitors.
7)Severe pleural, abdominal or cardiac effusion.
8) Patients with symptomatic brain metastasis
9)Patients with active concomitant malignancy
10)Pregnant, lactating women.
11)Inappropriate patients judged by physicians
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Satoshi Oizumi
Organization Hokkaido University
Division name Department of Respiratory Medicine
Zip code
Address North 15,West7, Kita-ku, Sapporo060-8638, Japan
TEL 011-706-5911
Email soizumi@med.hokudai.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hajime Asahina
Organization Hokkaido University
Division name Department of Respiratory Medicine
Zip code
Address North 15,West7, Kita-ku, Sapporo060-8638, Japan
TEL 011-706-5752
Homepage URL
Email hajime.asahina@gmail.com

Sponsor
Institute Hokkaido Lung Cancer Clinical Study Group
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

Other administrative information
Date of disclosure of the study information
2011 Year 03 Month 25 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
2011 Year 01 Month 24 Day
Date of IRB
Anticipated trial start date
2011 Year 03 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
2011 Year 03 Month 25 Day
Last modified on
2016 Year 04 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006313

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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