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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000012292
Receipt No. R000014375
Scientific Title Randomized Phase 2 trial of Individualized Monotherapy based on CYFRA-21-1 serum levels before treatment Versus Pemetrexed Monotherapy in Older Patients With Advanced Nonsquamous Non-Small-Cell Lung Cancer and wild-type EGFR tumors
Date of disclosure of the study information 2013/11/14
Last modified on 2013/11/14

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Basic information
Public title Randomized Phase 2 trial of Individualized Monotherapy based on CYFRA-21-1 serum levels before treatment Versus Pemetrexed Monotherapy in Older Patients With Advanced Nonsquamous Non-Small-Cell Lung Cancer and wild-type EGFR tumors
Acronym Individualized Chemotherapy based on CYFRA-21-1 serum levels in Older Non-Sq NSCLC Patients
Scientific Title Randomized Phase 2 trial of Individualized Monotherapy based on CYFRA-21-1 serum levels before treatment Versus Pemetrexed Monotherapy in Older Patients With Advanced Nonsquamous Non-Small-Cell Lung Cancer and wild-type EGFR tumors
Scientific Title:Acronym Individualized Chemotherapy based on CYFRA-21-1 serum levels in Older Non-Sq NSCLC Patients
Region
Japan

Condition
Condition Older patients with advanced nonsquamous non-small-cell lung cancer
Classification by specialty
Pneumology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy of Pemetrexed in older patients with EGFR mutation negative advanced nonsquamous non-small-cell lung cancer and to study relationships between the efficacy of Pemetrexed in them and CYFRA-21-1 serum level as predictive biomarker.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 6-month progression-free survival rate
Key secondary outcomes

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 A Pmetrexed(500mg/m2) given on day1 every 3 weeks in case of low CYFRA-21-1 serum level
A Docetaxel(60mg/m2) given on day1 every 3 weeks or Gemcitabine(1,000mg/m2) given on day1, day8 every 3 weeks in case of high CYFRA-21-1 serum level
Interventions/Control_2 B Pmetrexed(500mg/m2) given on day1 every 3 weeks
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) Histologically or cytologically confirmed advanced non-squamous non-small-cell lung cancer
2) No prior chemotherapy
3) Wild type EGFR
4) Clinical stage IIIB (not amenable to curative radiation), IV or recurrent disease
5) With one or more measurable disease or evaluable disease (RECIST ver.1.1)
6) 75 years of age or older
7) Performamne status of 0 or 1
8) Adequate organ function
9) Life expectancy more than 3 months
10) Written informed consent
Key exclusion criteria 1) Squamous cell carcinoma
2) Interstitial pneumonia or pulmonary fibrosis detectable on CT scan
3) History of drug-induced pneumonitis
4) History of poorly controlled pleural effusion,pericardial effusion and ascites
5) No oral supplement of folic acid and no injection of vitamin B12
6) Superior vena cava syndrome
7) Symptomatic brain metastasis
8) Uncontrollable hypertension or diabetes mellitus
9) History of severe heart disease (acute cardiac infarction or unstable angina within 6 months of registration, post-PTCA, post-CABG, sign of heart failure, uncontrollable arrythmia)
10) Severe drug allergy
11) History of active infection
12) Active concomitant cancers
13) Those judged to be not suitable by the attending physician
Target sample size 80

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroshige Yoshioka
Organization Kurashiki Central Hospital
Division name Department of Respiratory Medicine
Zip code
Address 1-1-1, Miwa, Kurashiki, Okayama
TEL 086-422-0210
Email hirotin@kchnet.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name Akihiro Nishiyama
Organization Kurashiki Central Hospital
Division name Department of Respiratory Medicine
Zip code
Address 1-1-1, Miwa, Kurashiki, Okayama
TEL 086-422-0210
Homepage URL
Email an11901@kchnet.or.jp

Sponsor
Institute Kyoto Thoracic Oncology Research 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
2013 Year 11 Month 14 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 Open public recruiting
Date of protocol fixation
2013 Year 10 Month 10 Day
Date of IRB
Anticipated trial start date
2013 Year 11 Month 14 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
2013 Year 11 Month 14 Day
Last modified on
2013 Year 11 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014375

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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