UMIN-CTR Clinical Trial

Public title

Phase II Trial of Carboplatin plus S-1 for Previously Untreated Patients with Advanced Non-small-cell Lung Cancer complicated by Interstitial Pneumonia

Acronym

Phase II Trial of CBDCA + S-1 for NSCLC with IP

Scientific Title

Phase II Trial of Carboplatin plus S-1 for Previously Untreated Patients with Advanced Non-small-cell Lung Cancer complicated by Interstitial Pneumonia

Scientific Title:Acronym

Phase II Trial of CBDCA + S-1 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

The present study was planned with the objective of investigating the combination of carboplatin and S-1 in the treatment of previously untreated patients with advanced non-small-cell lung cancer complicated by interstitial pneumonia. This study is designed as a phase II study of assessment of the efficacy and safety.

Basic objectives2

Safety

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II

Primary outcomes

Response Rate

Key secondary outcomes

Progression Free Survival, Overall Survival, 1 year survival rate, Quality of Life, Adverse Event

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

Six cycles of Carboplatin(AUC 5, Day 1)+ S-1 (80mg/m2/day, 2week on/2week off)

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

80

years-old

>

Gender

Male and Female

Key inclusion criteria

1) Histologically or cytologically confirmed non-small-cell lung cancer with Chemo-naive patients
2)Incurable NSCLC with stage IIIB or stage IV
3)Patients with no prior chemotherapy or one year after adjuvant chemotherapy
4)Patients who have measurable lesion or evaluable lesion by RECIST
5)Age of 20 to 79 years old
6)ECOG PS 0-2
7)Patients with interstitial pneumonias
8)Patients with expected life for at 12 weeks
9)Patients who are able to take orally
10)Have adequate organ function within two week before study entry
WBC>=4000/mm3
Neutrophil>=1500/mm3
Hemoglobin>=9.0g/dl
Platelets>=100000/mm3
Total bilirubin>=1.5mg/dl
AST/ALT<=100IU
Creatinine<=1.2mg/dl
Creatinine clearance>=60mL/min
11) Merit with the chemotherapy
12) Written informed consent from the patients

Key exclusion criteria

1) Patients with pleural or pericardial effusion ,or ascites.
2) Patients with active double cancer.
3)Patients with significant complications.
4)Patients with serious diarrhea.
5)Patients with active infection.
6)Patients with symptomatic brain metastasis.
7)Being treated with flucytosine, phenytoin,warfarin.
8)Uncontrolled psychiatric disease.
9) allergic more than and equal to grade3.
10)History of serious allergic reaction with S-1 or CBDCA.
11)Patients with pregnancy or lactation.
12)Patients with HIV,HBV
13)Any patients judged by the investigator to be unfit to participate in the study

Target sample size

33

Name of lead principal investigator

1st name
Middle name
Last name	Yasuhiko Nishioka

Organization

Tokushima University Hospital

Division name

Department of Respiratory medicine and Rheumatology

Zip code

Address

3-18-15, Kuramoto-cho, Tokushima, Japan

TEL

+81-88-633-7127

Email

yasuhiko@tokushima-u.ac.jp

Name of contact person

1st name
Middle name
Last name	Soji Kakiuchi

Organization

Tokushima University Hospital

Division name

Department of Respiratory medicine and Rheumatology

Zip code

Address

3-18-15, Kuramoto-cho, Tokushima, Japan

TEL

+81-88-633-7127

Homepage URL

Email

kakiuchi@clin.med.tokushima-u.ac.jp

Institute

Department of Respiratory medicine and Rheumatology, Tokushima University Hospital

Institute

Department

Personal name

Organization

none

Organization

Division

Category of Funding Organization

Self funding

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

徳島大学病院（徳島県）、徳島県立中央病院（徳島県）、徳島市民病院（徳島県）、徳島県立三好病院（徳島県）、高松赤十字病院（香川県）、国立病院機構高知病院（高知県）、高知医療センター（高知県）、高知赤十字病院（高知県）、松山赤十字病院（愛媛県）、国立病院機構大阪医療センター（大阪府）、聖路加国際病院（東京都）

Date of disclosure of the study information

2013

Year

06

Month

26

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

Preinitiation

Date of protocol fixation

2013

Year

03

Month

31

Day

Date of IRB

Anticipated trial start date

2013

Year

04

Month

01

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2013

Year

06

Month

26

Day

Last modified on

2014

Year

07

Month

01

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011904