UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000011694
Receipt number R000013671
Scientific Title Feasibility Study on Adjuvant Calboplatin and S-1 in patients with completely resected stage II-IIIA Non-Small Cell Lung Cancer
Date of disclosure of the study information 2013/09/11
Last modified on 2014/12/02 18:20:18

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Basic information

Public title

Feasibility Study on Adjuvant Calboplatin and S-1 in patients with completely resected stage II-IIIA Non-Small Cell Lung Cancer

Acronym

Feasibility Study on Adjuvant Calboplatin and S-1 in patients with completely resected stage II-IIIA Non-Small Cell Lung Cancer

Scientific Title

Feasibility Study on Adjuvant Calboplatin and S-1 in patients with completely resected stage II-IIIA Non-Small Cell Lung Cancer

Scientific Title:Acronym

Feasibility Study on Adjuvant Calboplatin and S-1 in patients with completely resected stage II-IIIA Non-Small Cell Lung Cancer

Region

Japan


Condition

Condition

Non-small cell lung cancer

Classification by specialty

Pneumology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the feasibility of carboplatiun and s-1 as adjuvant chemotherapy in patients with completely resected stage II-IIIa non-small cell lung cancer

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase

Phase II


Assessment

Primary outcomes

Accomplishment of 3 course treatment

Key secondary outcomes

Safty, 2yr RFS


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 is administered by an infusion lasting 60 minutes on day 1 and S-1 is administered twice a day on day1-14. Every 3 weeks for 4 courses

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

75 years-old >=

Gender

Male and Female

Key inclusion criteria

1) Histologically or cytologically determined non-small cell lung cancer.
2) Pathological stageIIA, IIB, IIIA. Completely resected.
3) Neither previous chemotherapy nor radiotherapy before operation.
4) ECOG performance status 0 or 1.
5) Aged 20-75 years old.
6) Adequate organ function.
White blood cell count >= 4,000 /mm3
Neutrophil count >= 1,500 /mm3
Hemoglobin >= 9.0 g/dL
Platelet count >= 100,000 /mm3
AST and ALT <= 100 IU/L
Total bilirubin <or= 1.5 mg/dL
Serum creatinine <= 1.25 mg/dL
PaO2 >= 60.0 torr
7) Patients are excepted to live at least 3 months
8) Written informed consent

Key exclusion criteria

1) Interstitial pneumonia or pulmonary fibrosis detectable on X ray.
2) Severe concurrent disease (Ischemic heart disease requiring treatment, hepatic failure, controlled diabetes, infection, psychiatric disorder).
3) Patients who are pregnant,considering pregnancy oractaing.
4) Receiving systemic treatment of steroid or immunosuppressant.
5) History of active double cancerwithin 5years prior to the study.
6) Other conditions not suitable forthis study.

Target sample size

25


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Takeshi Morimoto

Organization

Hirosaki University Graduate School of Medicine

Division name

Department of Cardiology, Respiratory Medicine and Nephrology

Zip code


Address

5 Zaifu-cho, Hirosaki, Aomori, 036-8562 Japan

TEL

0172-39-5057

Email

moritaka@cc.hirosaki-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Hisashi Tanaka

Organization

Hirosaki University Graduate School of Medicine

Division name

Department of Cardiology, Respiratory Medicine and Nephrology

Zip code


Address

5 Zaifu-cho, Hirosaki, Aomori, 036-8562 Japan

TEL

0172-39-5057

Homepage URL


Email

h-tanaka@cc.hirosaki-u.ac.jp


Sponsor or person

Institute

Hirosaki University Graduate School of Medicine

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

弘前大学附属病院(青森県),弘前中央病院(青森県),国立病院機構弘前病院(青森県)


Other administrative information

Date of disclosure of the study information

2013 Year 09 Month 11 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

Terminated

Date of protocol fixation

2012 Year 06 Month 27 Day

Date of IRB


Anticipated trial start date

2012 Year 07 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 09 Month 10 Day

Last modified on

2014 Year 12 Month 02 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013671


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name