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

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 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


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

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name