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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000026093
Receipt No. R000029985
Scientific Title Phase I study of Vinorelbine(VNR) and S-1 combination therapy for the elderly patients with advanced non-small-cell lung cancer.
Date of disclosure of the study information 2017/02/13
Last modified on 2017/02/11

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Basic information
Public title Phase I study of Vinorelbine(VNR) and S-1 combination therapy for the elderly patients with advanced non-small-cell lung cancer.
Acronym Phase I study of VNR and S-1 combination therapy.
Scientific Title Phase I study of Vinorelbine(VNR) and S-1 combination therapy for the elderly patients with advanced non-small-cell lung cancer.
Scientific Title:Acronym Phase I study of VNR and S-1 combination therapy.
Region
Japan

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

Objectives
Narrative objectives1 We evaluate the recommended dose , efficacy and safety of S-1 and VNR combination therapy for the elderly patients with advanced non-small-cell lung cancer.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase I

Assessment
Primary outcomes Recommended dose of S-1 and VNR combination therapy.
Key secondary outcomes We evaluate the efficacy and safety of S-1 and VNR combination therapy for the elderly patients with advanced non-small-cell lung cancer.

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 S-1 and Vinorelbine
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) Histologically or cytologically confirmed Stage IIIB/IV non-squamous non-small cell lung cancer
2) 70<= years
3) No Previously treated chemotherapy
4) With one or more measurable disease based on RECIST (ver.1.1)
5) Performance Status (ECOG) : 0-2
6) Adequate function of vital organs, including normal hematopoietic liver
and renal function as following:
WBC >= 3,000/mm3
Neutrophils >= 1,500/mm3
Hemoglobin >= 9.0 g/dL
Platelets >= 75,000/mm3
AST and ALT < 100IU/I
Total bilirubin <= 1.5mg/mL
Serum creatinine <= 1.5mg/dL
PT-INR <1.5
Urinary protein <= 1+
7) A life expectancy of more than 3 months
8) Written informed consent before initiation of study-related procedures
Key exclusion criteria 1) Symptomatic brain metastasis
2) Severe infection
3) Severe comorbidity (heart failure Tendency to hemorrhages uncontrollable hypertension, uncontrollable diabetes, etc)
4)Interstitial pneumonia or pulmonary fibrosis detectable on X ray.
5) Planning of surgery or thoracic radiotherapy during the trial.
6) With a history of drug sensitivity for S-1 or Vinorelbine.
7) Any other medical condition that makes the patient unsuitable for inclusion in the study according to the opinion of the investigator.
Target sample size 9

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Mikio Takamori
Organization Tokyo Metropolitan Tama Medical Center
Division name Department of respiratory medicine and clinical oncology
Zip code
Address 2-8-29 Musashidai, Fuchu-shi, Tokyo
TEL 042-323-5111
Email mikio_takamori@tmhp.jp

Public contact
Name of contact person
1st name
Middle name
Last name Mikio Takamori
Organization Tokyo Metropolitan Tama Medical Center
Division name Department of respiratory medicine and clinical oncology
Zip code
Address 2-8-29 Musashidai, Fuchu-shi, Tokyo
TEL 042-323-5111
Homepage URL
Email mikio_takamori@tmhp.jp

Sponsor
Institute Tokyo Metropolitan Tama Medical Center
Department of respiratory medicine and clinical oncology
Institute
Department

Funding Source
Organization Tokyo Metropolitan Tama Medical Center
Department of respiratory medicine and clinical oncology
Organization
Division
Category of Funding Organization Other
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 東京都立多摩総合医療センター

Other administrative information
Date of disclosure of the study information
2017 Year 02 Month 13 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
2016 Year 12 Month 01 Day
Date of IRB
Anticipated trial start date
2017 Year 02 Month 21 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
2017 Year 02 Month 11 Day
Last modified on
2017 Year 02 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029985

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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