UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000011046
Receipt number R000011904
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
Date of disclosure of the study information 2013/06/26
Last modified on 2014/07/01 00:56:29

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Basic information

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

Condition

Non-small cell lung cancer

Classification by specialty

Pneumology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

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


Assessment

Primary outcomes

Response Rate

Key secondary outcomes

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


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

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



Eligibility

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


Research contact person

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


Public contact

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


Sponsor or person

Institute

Department of Respiratory medicine and Rheumatology, Tokushima University Hospital

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


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

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)


Other administrative information

Date of disclosure of the study information

2013 Year 06 Month 26 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

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

Other related information



Management 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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name