UMIN-CTR Clinical Trial

Public title

A Feasibility study of alternate-day administrations of TS-1 as previously treated advanced non-small cell lung cancer in elderly patients

Acronym

A Feasibility study of alternate-day administrations of TS-1 as previously treated advanced non-small cell lung cancer in elderly patients

Scientific Title

A Feasibility study of alternate-day administrations of TS-1 as previously treated advanced non-small cell lung cancer in elderly patients

Scientific Title:Acronym

A Feasibility study of alternate-day administrations of TS-1 as previously treated advanced non-small cell lung cancer in elderly patients

Region

Japan

Condition

Previously treated non-small cell lung cancer

Classification by specialty

Pneumology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To evaluate the safty of alternate-day administrations of TS-1 as previously treated advanced non-small cell lung cancer in elderly patients

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Developmental phase

Phase II

Primary outcomes

Safety

Key secondary outcomes

1yr OS,PFS,DCR

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

administration of 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

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)Stage III,IV non-small cell lung cancer without any indications for radiotherapy
3)75<= years
4)Performance Status (ECOG):0-1
5)Previously treated one or more chemotherapy regimens
6)A life expectancy of more than 3 months
7)Patients who can take in drug orally
8)Adequate function of vital organs, including normal hematopoietic
liver and renal function as following:
WBC >= 3,000/mm3
Neutrophils >= 1,500/mm3
Platelets >= 100,000/mm3
Hemoglobin >= 9.0 g/dL
Total bilirubin <= 1.5mg/mL
AST and ALT, x2.5 of upper limit of normal(ULN) or less
Serum creatinine <= 1.5mg/dL
Creatinin crealance>=50mL/min

Key exclusion criteria

1) Interstitial pneumonia or pulmonary fibrosis detectable on X ray.
2) Massive pleural or pericardial effusion,ascites
3) History of active double cancer within 5 years prior to the study.
4) Patients having active other cancers.
5) Ileus, Interstitial
6) Uncontrolled diabetes mellitus
7) Cardiac infarction or unstable angina within 6 months
8) Symptomatic brain metastases
9) Concomitant therapy with flucytocine, phenytoin or Warfarin
Potassium
10) Serious psychiatric illness
11) History of severe hypersensitivity(>=Grade3)
12) History of using 5-FU o
13) Patient who is not candidates for TS-1
14) HBV-positive patients
15) Evaluated to be ineligible by a physician for other reasons

Target sample size

10

Name of lead principal investigator

1st name
Middle name
Last name	Noboru Hattori

Organization

Hiroshima University Hospital

Division name

Department of Respiratory Medicine

Zip code

Address

1-2-3,Kasumi,Minami-ku, Hiroshima,Japan

TEL

082-257-5196

Email

nhattori@hiroshima-u.ac.jp

Name of contact person

1st name
Middle name
Last name	Kazunori Fujitaka

Organization

Hiroshima University Hospital

Division name

Department of Respiratory Medicine

Zip code

Address

1-2-3,Kasumi,Minami-ku, Hiroshima,Japan

TEL

082-257-5196

Homepage URL

Email

fujikazu@hiroshima-u.ac.jp

Institute

Hiroshima University

Institute

Department

Personal name

Organization

none

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

安佐市民病院（広島県）、広島赤十字原爆病院（広島県）、　広島市民病院（広島県）、県立広島病院（広島県）、JA広島総合病院（広島県）

Date of disclosure of the study information

2013

Year

09

Month

18

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Completed

Date of protocol fixation

2013

Year

06

Month

01

Day

Date of IRB

Anticipated trial start date

2013

Year

06

Month

01

Day

Last follow-up date

2016

Year

04

Month

30

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2013

Year

09

Month

18

Day

Last modified on

2017

Year

03

Month

23

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012374