UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000003676
Receipt number R000004125
Scientific Title Maintenance TS-1 for advanced non-small cell lung cancer: a phase 2 study
Date of disclosure of the study information 2010/05/31
Last modified on 2020/12/01 14:11:09

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Maintenance TS-1 for advanced non-small cell lung cancer: a phase 2 study

Acronym

Maintenance TS-1

Scientific Title

Maintenance TS-1 for advanced non-small cell lung cancer: a phase 2 study

Scientific Title:Acronym

Maintenance TS-1

Region

Japan


Condition

Condition

Non-small cell lung cancer

Classification by specialty

Pneumology Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate efficacy and safety of maintenance TS-1 in advanced non-small cell lung cancer patients who achieved any response after platinum-doublet chemotherapy.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Time to treatment failure

Key secondary outcomes

Rate of adverse events, progression-free survival, overall survival


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

Maintenance TS-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) pathologically diagnosed non-small cell lung cancer patients
2) clinically stage IV (UICC, 7th edition)
3) CR, PR, or SD was achieved after prior platinum-doublet chemotherapy
4) No history of chemotherapy other than lung cancer, and radiotherapy of primary lung lesion
5) ECOG PS 0-1
6) Good major organ function
7) Written informed consent by patient

Key exclusion criteria

1) active multiple malignancy
2) infection, ileus, vomiting
3) history of hemoptysis
4) history of thrombotic or hemorrhagic
disorders
5) tumor invasion to major thoracic vessel
6) tumor cavitation
7) nonhealing bone fracture
8) uncontrolled digestive ulcer
9) uncontrolled hypertension
10) interstitial pneumonia
11) pregnancy or lactation
12) symptomatic brain metastasis
13) severe drug allergy
3)-6) was excluded only in patients who received bevacizumab-containing first-line chemotherapy.

Target sample size

78


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yuichiro Ohe

Organization

National Cancer Research Center Hospital East

Division name

Division of thoracic oncology

Zip code


Address

6-5-1, Kashiwanoha, Kashiwa

TEL

04-7133-1111

Email

yohe@ncc.go.jp


Public contact

Name of contact person

1st name
Middle name
Last name Seiji Niho

Organization

National Cancer Research Center Hospital East

Division name

Division of thoracic oncology

Zip code


Address

6-5-1, Kashiwanoha, Kashiwa, Chiba, Japan

TEL

04-7133-1111

Homepage URL


Email

siniho@east.ncc.go.jp


Sponsor or person

Institute

National Cancer Center Research Hospital East

Institute

Department

Personal name



Funding Source

Organization

a grant in aid for Cancer research from the Ministry of Health and Welfare, Japan.

Organization

Division

Category of Funding Organization

Japanese Governmental office

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

2010 Year 05 Month 31 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

Main results already published

Date of protocol fixation

2010 Year 05 Month 28 Day

Date of IRB

2010 Year 05 Month 28 Day

Anticipated trial start date

2010 Year 05 Month 29 Day

Last follow-up date

2015 Year 05 Month 27 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2010 Year 05 Month 30 Day

Last modified on

2020 Year 12 Month 01 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004125


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name