UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000042698
Receipt number R000048729
Scientific Title An ancillary study of (a randomized phase 2 study of TS-1 versus CDDP+VNR for adjuvant therapy in patients with non-small cell lung cancer)-exploratory study of cost-effectiveness
Date of disclosure of the study information 2020/12/09
Last modified on 2023/06/12 09:02:23

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Basic information

Public title

An ancillary study of (a randomized phase 2 study of TS-1 versus CDDP+VNR for adjuvant therapy in patients with non-small cell lung cancer)-exploratory study of cost-effectiveness

Acronym

LOGIK1702-B

Scientific Title

An ancillary study of (a randomized phase 2 study of TS-1 versus CDDP+VNR for adjuvant therapy in patients with non-small cell lung cancer)-exploratory study of cost-effectiveness

Scientific Title:Acronym

LOGIK1702-B

Region

Japan


Condition

Condition

Non-small-cell lung cancer

Classification by specialty

Pneumology Chest surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

We investigate the cost-effectiveness of each adjuvant chemotherapy in patients who enrolled in LOGIK1702 study (UMIN000027435)entitled (a randomized phase 2 study of TS-1 versus CDDP+VNR for adjuvant therapy in patients with non-small cell lung cancer)

Basic objectives2

Others

Basic objectives -Others

Cost minimization analysis, cost effectiveness ratio (CER), incremental cost effectiveness ratio (ICER), cost utility ratio, Incremental cost-utility ratio

Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

Cost-minimization analysis, cost- effectiveness ratio (CER), incremental cost-effectiveness ratio (ICER), cost-utility ratio, incremental cost-utility ratio

Key secondary outcomes



Base

Study type

Others,meta-analysis etc


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


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

20 years-old <=

Age-upper limit

75 years-old >=

Gender

Male and Female

Key inclusion criteria

1) Patients enrolled in LOGIK1702
2) Patients providing the written informed consent.

Key exclusion criteria

Nothing particular

Target sample size

110


Research contact person

Name of lead principal investigator

1st name Takeshi
Middle name
Last name Nagayasu

Organization

Nagasaki University Graduate School of Biomedical Sciences

Division name

Department of Surgical Oncology

Zip code

852-8501

Address

1-7-1 Sakamoto, Nagasaki, Nagasaki 852-8501, Japan

TEL

095-819-7304

Email

nagayasu@nagasaki-u.ac.jp


Public contact

Name of contact person

1st name Tomoshi
Middle name
Last name Tsuchiya

Organization

Toyama University Hospital

Division name

Respiratory surgery

Zip code

930-0194

Address

2630 Sugitani,Toyama, Toyama

TEL

076-434-7371

Homepage URL


Email

tomoshi@nagasaki-u.ac.jp


Sponsor or person

Institute

Clinical Research Support Center Kyushu

Institute

Department

Personal name



Funding Source

Organization

none

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor

Lung Oncology Group in Kyushu (LOGIK)

Name of secondary funder(s)



IRB Contact (For public release)

Organization

Nagasaki University Hospital Clinical Research Ethic Committee

Address

1-7-1 Sakamoto, Nagasaki, Nagasaki 852-8501, Japan

Tel

095-819-7905

Email

gaibushikin@ml.nagasaki-u.ac.jp


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

長崎大学病院(長崎県)


Other administrative information

Date of disclosure of the study information

2020 Year 12 Month 09 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

No longer recruiting

Date of protocol fixation

2020 Year 09 Month 28 Day

Date of IRB

2020 Year 11 Month 04 Day

Anticipated trial start date

2021 Year 01 Month 04 Day

Last follow-up date

2027 Year 05 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

1)Expense data collected
All direct medical expenses (insurance points) in conjunction with adjuvant chemotherapy that cost during one and half years after adjuvant chemotherapy.
The following expenses are also included.
・Medical expenses cost for a recurrence and an adverse event
・Medical expenses cost for a postoperative complication
・Medical expenses cost for the underlying disease that patients originally have
2) Analysis method
According to National Institute for Health and Clinical Excellence (NICE) guideline and analysis guideline of cost-effectiveness estimation in Japanese Central Social Insurance Conference (Jan. 2016), the following three analyses are considered.
1) Cost-minimization analysis
The analysis is carried out only if the effectiveness is judged to be similar by the investigator.
2) Cost-effectiveness analysis
Cost-effectiveness ratio (CER) and incremental cost-effectiveness ratio (ICER)
3) Cost-utility analysis


Management information

Registered date

2020 Year 12 Month 09 Day

Last modified on

2023 Year 06 Month 12 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048729


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name