UMIN-CTR Clinical Trial

Unique ID issued by UMIN C000000054
Receipt number R000000100
Scientific Title Phase I–II study of TS-1 and Carboplatin in advanced Non Small Lung Cancer
Date of disclosure of the study information 2005/09/04
Last modified on 2005/09/08 11:07:22

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Phase I–II study of TS-1 and Carboplatin in advanced Non Small Lung Cancer

Acronym

Phase I–II study of TS-1 and Carboplatin in advanced Non Small Lung Cancer

Scientific Title

Phase I–II study of TS-1 and Carboplatin in advanced Non Small Lung Cancer

Scientific Title:Acronym

Phase I–II study of TS-1 and Carboplatin in advanced Non Small Lung Cancer

Region

Japan


Condition

Condition

non small cell lung cancer

Classification by specialty

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To estimate the maximum tolerable dose and recommended dose of TS1 and carboplatin., and to determine the efficacy and safety of the combination of TS1 and carboplatin in patients with NSCLC

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Decision of the recommended dose of TS1 and carboplatin

Key secondary outcomes

Determination of dose limited toxicity and response and safety of the combination of TS1 and carboplatin


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

TS1: 65 or 80 mg/body/day, orally 14 days, every 3 weeks
Carboplatin: AUC 4.0, 5.0 or 6.0

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) Stage IIIB or IV NSCLC
2) No indication of curable chemoradiation
3) Chemonaive
4) At least one measurable lesion
5) 75 > Age > 20 years
6) Performance status (PS) of 0 to 1
7) Adequate main organ functions
WBC > 4000/mm3
Plt > 100000/mm3
Hb > 9.0g/dl
T-bil < 2.0mg/dl
GOT < 100 IU/L, GPT < 100IU/L
Creatinine clearance < normal range
PaO2 > 60mmHg
8) No limitation of outpatients
9) Written informed consent

Key exclusion criteria

1) History of active other malignancy
2) Severe heart disease (uncontrolled angina pectoris , myocardial infarction, heart failure within 3 months
3) Uncontrolled diabetes
4) Severe complication (infection, bowel obstruction, or hemorrhage etc.)
5) Intestinal pneumonia or lung fibrosis
6) Severe diarrhea
7) Massive pleural, cardiac, or abdominal effusion
8) Regular use of fenitoin, warfarin or frucitocin
9) Symptomatic brain metastasis
10) History of severe drug allergic reaction
11) History of bone marrow plantation or self peripheral blood stimulated transportation
12) Pregnant women or women willing child-bearing
13) Inadequate condition diagnosed by primary physician

Target sample size

25


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kenji Tamura MD

Organization

Kinki University School of Medicine, Nara Hospital

Division name

Department of Medical Oncology

Zip code


Address

1248-1, Otoda, Ikoma, Nara, 630-0293, Japan

TEL

0743-77-0880

Email



Public contact

Name of contact person

1st name
Middle name
Last name

Organization

Kinki University School of Medicine, Nara Hospital

Division name

Department of Medical Oncology

Zip code


Address


TEL

072-366-0221

Homepage URL


Email



Sponsor or person

Institute

Department of Medical Oncology,

Kinki University School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Department of Medical Oncology,

Kinki University School of Medicine

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



Other administrative information

Date of disclosure of the study information

2005 Year 09 Month 04 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

Date of protocol fixation

2005 Year 02 Month 17 Day

Date of IRB


Anticipated trial start date

2005 Year 02 Month 01 Day

Last follow-up date

2007 Year 02 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2005 Year 08 Month 10 Day

Last modified on

2005 Year 09 Month 08 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000100


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name