UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026093 |
|---|---|
| Receipt number | 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 | 2020/08/14 16:16:11 |
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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
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
mikio_takamori@tmhp.jp
Sponsor or person
Institute
Tokyo Metropolitan Tama Medical Center
Department of respiratory medicine and clinical oncology
Institute
Department
Personal name
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
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
Terminated
Date of protocol fixation
| 2016 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 02 | Month | 20 | Day |
Anticipated trial start date
| 2017 | Year | 02 | Month | 21 | Day |
Last follow-up date
| 2020 | Year | 08 | Month | 14 | Day |
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
| 2020 | Year | 08 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029985
