UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000009399
Receipt number R000011036
Scientific Title Phase I/II trial of Nedaplatin/S-1 combination followed by maintenance S-1 therapy in advanced Squamous Cell Lung Cancer
Date of disclosure of the study information 2012/11/26
Last modified on 2012/11/26 11:16:31

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Basic information

Public title

Phase I/II trial of Nedaplatin/S-1 combination followed by maintenance S-1 therapy in advanced Squamous Cell Lung Cancer

Acronym

Phase I/II trial of Nedaplatin/S-1 combination followed by maintenance S-1 therapy in advanced Squamous Cell Lung Cancer

Scientific Title

Phase I/II trial of Nedaplatin/S-1 combination followed by maintenance S-1 therapy in advanced Squamous Cell Lung Cancer

Scientific Title:Acronym

Phase I/II trial of Nedaplatin/S-1 combination followed by maintenance S-1 therapy in advanced Squamous Cell Lung Cancer

Region

Japan


Condition

Condition

Advanced Squamous Cell Lung Cancer

Classification by specialty

Pneumology Adult

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To establish the toxicities and maximum tolerated dose (MTD) of nedaplatin with S-1, and to determine the recommended dose (RD) for Advanced Squamous Cell Lung Cancer.

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase

Phase I,II


Assessment

Primary outcomes

To establish MTD and to determine the RD.

Key secondary outcomes

safty,PFS,OS and RR.


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

nedaplatin,S-1

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

Stage IIIB or IV squamous cell lung carcinoma
No indication of curable chemoradiation
Chemonaive
At least one measurable lesion
Age>20 years
Performance status of 0 to 1
Adequate main organ functions
WBC>3000/mm3
NET>1500/mm3
Plt>100000/mm3
Hb>9.0g/dl
T-bil<1.5mg/dl
GOT<100 IU/L, GPT<100IU/L
Creatinine<1.2mg/dL
Creatinine clearance>60mL/min
PaO2>60mmHg
No limitation of outpatients
Written informed consent

Key exclusion criteria

History of active other malignancy
Severe heart disease
Severe complication
Intestinal pneumonia or lung fibrosis
Severe diarrhea
Massive pleural, cardiac, or abdominal effusion
Regular use of fenitoin, warfarin or frucitocin
Symptomatic brain metastasis
History of severe drug allergic reaction
Pregnant women or women willing child bearing
Inadequate condition diagnosed by primary physician

Target sample size

25


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Isamu Okamoto

Organization

Kinki University Faculty of Medicine

Division name

Department of Medical Oncology

Zip code


Address

377-2 Ohno-higashi, Osaka-Sayama, Osaka 589-8511, Japan

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name

Organization

Kinki University Faculty of Medicine

Division name

Department of Medical Oncology

Zip code


Address


TEL


Homepage URL


Email



Sponsor or person

Institute

Department of Medical Oncology, Kinki University Faculty of Medicine

Institute

Department

Personal name



Funding Source

Organization

Department of Medical Oncology, Kinki University Faculty 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

2012 Year 11 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

Open public recruiting

Date of protocol fixation

2012 Year 10 Month 25 Day

Date of IRB


Anticipated trial start date

2012 Year 11 Month 26 Day

Last follow-up date

2017 Year 10 Month 25 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2012 Year 11 Month 26 Day

Last modified on

2012 Year 11 Month 26 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011036


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name