UMIN-CTR Clinical Trial

Public title

S-1 as second line for non-small cell lung cancer with preexisting interstitial pneumonia: phase II study.

Acronym

S-1 as 2nd line for NSCLC with IP

Scientific Title

S-1 as second line for non-small cell lung cancer with preexisting interstitial pneumonia: phase II study.

Scientific Title:Acronym

S-1 as 2nd line for NSCLC with IP

Region

Japan

Condition

non-small cell lung cancer

Classification by specialty

Pneumology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To investigate efficacy and safety of S-1 as second line for non-small cell lung cancer with preexisting interstitial pneumonia.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

progression free survival (PFS)

Key secondary outcomes

overall survival
1 year survival rate
response rate
disease control rate
safety
incidence of acute exacerbation of preexisting interstitial pneumonia

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Historical

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

S-1, day 1- 28, q6w.

body surface area (BSA) >1.5m2 S-1 80 mg/day
BSA 1.25 - 1.5m2 S-1 100 mg/day
BSA > 1.5m2 S-1 120 mg/day

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

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1) pathologically confirmed non small cell lung cancer
2) stage IIIB/IV or relapsed patients who received anti-cancer agents once.
3) patients with preexisting interstitial pneumonia
4) more than 20 years old
5) ECOG PS 0-2
6) life expectancy for more than 3 months
7) more than one measurable lesion
8) ability to take medications per oral
9) preserved main organs function
10) Informed consent with documents by participants.

Key exclusion criteria

1) deterioration of preexisting interstitial pneumonia within 3 months (acute/sub-acute cases)
2) history of acute exacerbation of preexisting interstitial pneumonia or drug induced lung injury.
3) taking corticosteroids more than 15 mg/day of prednisolon or equal
4) taking immunosuppressant
5) received irradiation to lung within 3 months
6) using home oxygen therapy (HOT)
7) history of treatment with fluorinated pyrimidine
8) contraindicated for S-1
9) symptomatic, unstable brain metastasis
10) with pleural or peritoneal effusions which need to be drainage
11) with watery diarrhea
12) with severe comorbidities considered to be obstacle for anti-cancer therapy.
13) with metachronous or synchronous multiple cancer
14) using flucytosine
15) being pregnant or have an intention to be or make pregnant, or breast feeding.
16) considered as inappropriate to be participant by the primary physician

Target sample size

28

Name of lead principal investigator

1st name
Middle name
Last name	Takafumi Suda

Organization

Hamamatsu University School of Medicine

Division name

2nd division, Department of Internal Medicine

Zip code

Address

1-20-1 Handayama, Higashi Ward, Hamamatsu, Shizuoka, Japan. 431-3192

TEL

053-435-2111

Email

suda@hama-med.ac.jp

Name of contact person

1st name
Middle name
Last name	Norimichi Akiyama

Organization

Hamamatsu University School of Medicine

Division name

2nd division, Department of Internal Medicine

Zip code

Address

1-20-1 Handayama, Higashi Ward, Hamamatsu, Shizuoka, Japan. 431-3192

TEL

053-436-1251

Homepage URL

Email

nakiyan@hama-med.ac.jp

Institute

Hamamatsu University School of Medicine

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

Date of disclosure of the study information

2016

Year

05

Month

11

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

Date of protocol fixation

2016

Year

05

Month

10

Day

Date of IRB

Anticipated trial start date

2016

Year

06

Month

10

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2016

Year

05

Month

02

Day

Last modified on

2018

Year

07

Month

11

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025296