UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000003332
Receipt number R000004039
Scientific Title Phase I/II study of nedaplatin, a cisplatin analogue, and S-1 in patients with advanced squamous cell lung carcinoma.
Date of disclosure of the study information 2010/03/15
Last modified on 2015/07/31 17:46:21

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Basic information

Public title

Phase I/II study of nedaplatin, a cisplatin analogue, and S-1 in patients with advanced squamous cell lung carcinoma.

Acronym

Phase I/II study of nedaplatin, a cisplatin analogue, and S-1 in patients with advanced squamous cell lung carcinoma.

Scientific Title

Phase I/II study of nedaplatin, a cisplatin analogue, and S-1 in patients with advanced squamous cell lung carcinoma.

Scientific Title:Acronym

Phase I/II study of nedaplatin, a cisplatin analogue, and S-1 in patients with advanced squamous cell lung carcinoma.

Region

Japan


Condition

Condition

advanced squamous cell lung carcinoma

Classification by specialty

Pneumology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To assess the safety and efficacy for combination chemotherapy of Nedaplatin and S-1 in patients with advanced squamous cell lung carcinoma.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Phase I : DLT (Dose-Limiting Toxicity)
Phase II : RR (Response Rate)

Key secondary outcomes



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

Patients receive nedaplatin(80-100 mg/m2, day1) plus S-1(80-120 mg/day, day1-14) every 3 weeks.

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

80 years-old >=

Gender

Male and Female

Key inclusion criteria

1.Sufficient oral intake
2.Histologically or cytologically confirmed squamous cell or adenosquamous cell lung cancer. Stage III without any indications for radiotherapy or Stage IV.
3.Age: 20 years to less than 80 years.
4.Patients with no previous treatment ( chemotherapy or radiotherapy) for lung cancer. Incrude recurrent disease after surgery who have no prior chemoterapy.
5.Measurable by RECST(ver 1.1) criteria.
6.adequate bone marrow, liver, and renal functions
Hb > 9.0 g/dL-1
WBC > 3500-12,000 mm-3
neutro > 2,000 mm-3
Plt > 100,000 mm-3
T-Bil< 1.5x upper normal limit
AST(GOT), ALT(GPT)< 1.5x upper normal limit
creatinine clearance > 60 ml/min
Pao2 > 60mmHg or SpO2 > 90%
7.ECOG performance status of 0 or 1
8.a life expectancy of 12 weeks or more
9.Written informed consent

Key exclusion criteria

1.History of grave drug allergic reaction
2.Patients under treatment with phenytoin or flucytosine.
3.Serious complications (e.g. intestinal paralysis, intestinal obstruction, interstitial pneumonia or fibroid lung detectable on chest X-ray films
, poorly controlled diabetes, heart failure, renal failure, hepatic failure, or haemorrhagic peptic ulcer etc.).
Serious medical complications
4. History of poorly controlled pleural effusion,pericardial effusion and ascites .
5.Symptomatic brain metastasis
6.Patients with uncontrolled water diarrhea or chronic constipation.
7.Active double cancer. Carcinoma in situ and lesions of intramucosal carcinoma will not be included in active double cancer and will be permitted for registration.
8.Pregnant females, possibly pregnant females, females wishing to become pregnant and nursing mothers.
9.Males that are currently attempting to produce a pregnancy.
10.Inadequate physical condition, as diagnosed by primary physician.

Target sample size

45


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Soejima Kenzo

Organization

Keio University School of Medicine

Division name

Division of Pulmonary medicine

Zip code


Address

35 Shinanomachi, Shinjuku-ku, Tokyo

TEL

03-3353-121

Email

ksoejima@cpnet.med.keio.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Katsuhiko Naoki

Organization

Keio University School of Medicine

Division name

Division of Pulmonary Medicine

Zip code


Address

35 Shinanomachi, Shinjuku-ku, Tokyo

TEL

03-5363-3793

Homepage URL


Email

naoki@z5.keio.ac.jp


Sponsor or person

Institute

Keio University School of Medicine, division of Pulmonary Medicine

Institute

Department

Personal name



Funding Source

Organization

Keio University School of Medicine, division of Pulmonary 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

2010 Year 03 Month 15 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

2010 Year 03 Month 15 Day

Date of IRB


Anticipated trial start date

2010 Year 03 Month 01 Day

Last follow-up date


Date of closure to data entry

2014 Year 06 Month 30 Day

Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2010 Year 03 Month 13 Day

Last modified on

2015 Year 07 Month 31 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004039


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name