UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000007433
Receipt number R000008747
Scientific Title A Phase II Study of Carboplatin and S-1 Followed by S-1 Maintenance for Patients Who Have Squamous Cell Lung Carcinoma
Date of disclosure of the study information 2012/03/02
Last modified on 2012/09/14 16:06:53

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Basic information

Public title

A Phase II Study of Carboplatin and S-1 Followed by S-1 Maintenance for Patients Who Have Squamous Cell Lung Carcinoma

Acronym

CJLSG1102

Scientific Title

A Phase II Study of Carboplatin and S-1 Followed by S-1 Maintenance for Patients Who Have Squamous Cell Lung Carcinoma

Scientific Title:Acronym

CJLSG1102

Region

Japan


Condition

Condition

Squamous Cell Lung Carcinoma

Classification by specialty

Pneumology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

The aim of the present study is to assess the effectiveness and safety of maintenance therapy for patients previously untreated non-small cell lung cancer.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II


Assessment

Primary outcomes

12w-Disease control rate

Key secondary outcomes

Overall Survival,
Progression Free Survival,
Ratio of entering to Maintenance Therapy,
Safety,
Quality of Life


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

Carboplatin and S-1 followed by S-1 maintenance

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


Not applicable

Gender

Male and Female

Key inclusion criteria

1) Better than SD after 4 cycles of S-1 plus carboplatin as initial therapy.
2) ECOG performance status (PS): 0-2
3) Adequate organ function.

Key exclusion criteria

1) Active infection or other serious disease condition (poorly controlled diabetes mellitus, cardiac disease, Unstable angina, Cardiac infarction, Psychological illness, etc.).
2) Pulmonary disorder(idiopathic pulmonary fibrosis,interstitial lung disease,pneumoconiosis,active radiation pneumonia,etc.).
3) Massive pleural effusion, pericardial effusion, ascites, and superior vena cava syndrome.
4) Symptomatic brain metastasis.
5) Grade 2 or higher diarrhea
6) Pregnant or nursing females
7) Patients whose participation in the trial is judged to be inappropriate by the attending doctor.

Target sample size

30


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Ryujiro Suzuki

Organization

Toyohashi Municipal Hospital

Division name

Department of Respiratory Medicine

Zip code


Address

50 Hachiken-nishi, Aotake, Toyohashi, Aichi 441-8570, Japan.

TEL

0532-33-6111

Email



Public contact

Name of contact person

1st name
Middle name
Last name Yoshihiro Takeyama

Organization

Toyohashi Municipal Hospital

Division name

Department of Respiratory Medicine

Zip code


Address

50 Hachiken-nishi, Aotake, Toyohashi, Aichi 441-8570, Japan.

TEL

0532-33-6111

Homepage URL


Email



Sponsor or person

Institute

Central Japan Lung Study Group (CJLSG)

Institute

Department

Personal name



Funding Source

Organization

Central Japan Lung Study Group (CJLSG)

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

JAPAN


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

Central Japan Lung Study Group (CJLSG)


Other administrative information

Date of disclosure of the study information

2012 Year 03 Month 02 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

Open public recruiting

Date of protocol fixation

2012 Year 02 Month 23 Day

Date of IRB


Anticipated trial start date

2012 Year 03 Month 01 Day

Last follow-up date

2016 Year 02 Month 01 Day

Date of closure to data entry

2016 Year 02 Month 01 Day

Date trial data considered complete

2016 Year 02 Month 01 Day

Date analysis concluded

2016 Year 04 Month 01 Day


Other

Other related information



Management information

Registered date

2012 Year 03 Month 02 Day

Last modified on

2012 Year 09 Month 14 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008747


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name