UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000008083
Receipt number R000009518
Scientific Title A phase II Study of Carboplatin plus oral S1 in Chemo-Naive Patients with Squamous Cell Lung Cancer (OSAKA-LCSG1102)
Date of disclosure of the study information 2012/06/01
Last modified on 2018/12/17 10:13:52

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Basic information

Public title

A phase II Study of Carboplatin plus oral S1 in Chemo-Naive Patients with Squamous Cell Lung Cancer (OSAKA-LCSG1102)

Acronym

A phase II Study of Carboplatin plus oral S1 in Chemo-Naive Patients with Squamous Cell Lung Cancer (OSAKA-LCSG1102)

Scientific Title

A phase II Study of Carboplatin plus oral S1 in Chemo-Naive Patients with Squamous Cell Lung Cancer (OSAKA-LCSG1102)

Scientific Title:Acronym

A phase II Study of Carboplatin plus oral S1 in Chemo-Naive Patients with Squamous Cell Lung Cancer (OSAKA-LCSG1102)

Region

Japan


Condition

Condition

Chemo-Naïve Patients with Squamous Cell Lung Cancer

Classification by specialty

Pneumology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To investigate the efficacy and safety of Carboplatin plus oral S1 followed by maintenance S1 treatment in Chemo-Naive Patients stage IIIB/IV with Squamous Cell Lung Cancer

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase

Phase II


Assessment

Primary outcomes

Response rate

Key secondary outcomes

Progression-free survival, Progression-free survival of maintenance treatment, Overall survival, Frequency and grade of 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

Carboplatin AUC = 5(day1)+ S-1 80mg/m2 (day1~14) q3weeks 6 cycles followed by +S-1 80mg/m2(day1~14) q3weeks until disease progression

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.Histologically or cytologically confirmed squamous cell lung cancer
2.Stage IIIB/IV without any indications for radiotherapy, or recurrent disease after surgery
3.Measurable disease
4.Except for the surgical treatment for non-small cell lung cancer, patients have not been conducted prior treatment (radiation therapy, and chemotherapy)However, radiation therapy is not applied radiation field in the primary tumor, two weeks after irradiation final at the time of registration it is acceptable)
5.Age 20=<
6.ECOG performance status of 0 to 1
7.Patiants who can take in drug orally
8.Adequate organ function, evaluated within 14 days before enrollment as;
WBC >= 3,500 /mm3
Neu >= 1,500 /mm3
Plt >= 100,000 /mm3
hemoglobin >= 9.0 g/dL
AST (GOT) , ALT (GPT) =< 100 IU/L
T. bil =< 1.5 mg/dL
Cr >= 1.2mg/dL
SpO2 >= 90% or >= 60 torr
9.Expected to live over 12 weeks after administration days
10.Written informed consent from the patients

Key exclusion criteria

1.Adjuvant chemotherapy
2.Pneumonia or Pulmonary fibrosis detectable on chest X-rays. History of drug induced interstitial pneumonia.
3.History of severe drug allergy
4.Active synchronous malignancies
5.Patients with pleural effusion, ascites and/or pericardial effusion requiring drainage
6.Severe complication
7.Metastasis to CNS
8.Patients with chest radiation treatment is required to reach the lung irradiation
9.Treated by flucytosine (5-FC)
10.Women with a possibility of pregnancy, pregnant or lactating
11.Patients whose participation in the trial is judged to be inappropriate by the attending doctor

Target sample size

35


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Takashi Kijima

Organization

Osaka University Hospital

Division name

Dept. of Respiratory Medicine

Zip code


Address

2-15 Yamada-oka, Suita, Osaka, Japan

TEL

06-6879-3833

Email

tkijima@imed3.med.osaka-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Takashi Kijima

Organization

Osaka University Hospital

Division name

Dept. of Respiratory Medicine

Zip code


Address

2-15 Yamada-oka, Suita, Osaka, Japan

TEL

06-6879-3833

Homepage URL


Email

tkijima@imed3.med.osaka-u.ac.jp


Sponsor or person

Institute

Dept. of Respiratory Medicine,
Osaka University Hospital

Institute

Department

Personal name



Funding Source

Organization

Dept. of Respiratory Medicine,
Osaka University Hospital

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor

OSAKA-LCSG

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



Other administrative information

Date of disclosure of the study information

2012 Year 06 Month 01 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results

In the 33 patients analyzed, the rate of patients who met the primary endpoint was 30.3% (95% confidence interval: (15.6%-48.7%), and the disease control rate was 75.8%. The median PFS and OS were 3.5 and 11.3 months, respectively. Ten patients received maintenance S-1, and the median PFS from the beginning of induction treatment was 5.3 months. Grade 3/4 toxicities with a frequency of more than 5% were all controllable.

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

Completed

Date of protocol fixation

2010 Year 12 Month 01 Day

Date of IRB


Anticipated trial start date

2012 Year 04 Month 01 Day

Last follow-up date

2014 Year 01 Month 31 Day

Date of closure to data entry

2016 Year 01 Month 31 Day

Date trial data considered complete

2016 Year 01 Month 31 Day

Date analysis concluded

2016 Year 01 Month 31 Day


Other

Other related information



Management information

Registered date

2012 Year 06 Month 01 Day

Last modified on

2018 Year 12 Month 17 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009518


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name