UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000009308
Receipt number R000010930
Scientific Title Phase II study of Carboplatin and alternate-day administrations of TS-1 in patients with advanced squamous cell lung cancer.
Date of disclosure of the study information 2013/01/01
Last modified on 2017/11/14 09:07:48

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Basic information

Public title

Phase II study of Carboplatin and alternate-day administrations of TS-1 in patients with advanced squamous cell lung cancer.

Acronym

Phase II study of Carboplatin and alternate-day administrations of TS-1 in patients with advanced squamous cell lung cancer.

Scientific Title

Phase II study of Carboplatin and alternate-day administrations of TS-1 in patients with advanced squamous cell lung cancer.

Scientific Title:Acronym

Phase II study of Carboplatin and alternate-day administrations of TS-1 in patients with advanced squamous cell lung cancer.

Region

Japan


Condition

Condition

Squamous cell carcinoma of the lung

Classification by specialty

Pneumology Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the efficacy and feasibilty for Carboplatin and alternate-day administrations of TS-1 in patients with squamous cell lung cancer.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II


Assessment

Primary outcomes

Disease control rate (CR+PR+SD)

Key secondary outcomes

1.Overall survival
2.Progression-free survival from induction chemotherapy
3.Progression-free survival from maintenance chemotherapy
4.Percrntages of patients who received maintenance chemotherapy
5.Response rate
6.Toxicities


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

Induction chemotherapy with Carboplatin and alternate-day administrations of TS-1
for all registered patients.

Maintenance chemotherapy with alternate-day administrations of TS-1 for non-PD patients.

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 carcinoma of the lung
2.Stage IIIB/IV
3.Age >=20
4.PS(Eastern Cooperative Oncology Group:ECOG):0-2
5.Measurable lesion
6.Capable of oral intake
7.Adequate organ functions
neutrophils >=1,500/mm3
platelets >=100,000/mm3
hemoglobin >=9.0g/dL
total bilirubin <=2.0mg/dL
AST(GOT)/ALT(GPT) <=100IU/L
PaO2 >= 60torr or SpO2 >=90%
creatinine clearance >=30mL/min
8.Estimated life expectancy of at least 3 months
9.With written informed consent

Key exclusion criteria

1.Contraindication of TS-1, CBDCA
2)Patients received adjuvant chemotherapy
3.Pregnant females, possibly pregnant females, females wishing to become pregnant and nursing mothers. Males that are currently attempting to produce a pregnancy
4.Active infection
5.HBs antigen positive
6.Severe complications, such as ileus, heart failure and renal failure
7.Continuous diarrhea
8.Massive pleural effusion and ascites
9.Active concomitant malignancy
10.Patients under treatment with flucytosine, phenytoin or warfarin potassium
11.Patients under treatment with steroids
12.Inadequate physical condition, as diagnosed by primary physician

Target sample size

35


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Young Hak Kim

Organization

Kyoto University Hospital

Division name

Respiratory Medicine

Zip code


Address

54 Shogoin-Kawaharacho, Sakyoku, Kyoto, Japan

TEL

075-751-3830

Email

ekim@kuhp.kyoto-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Hiroki Nagai

Organization

Kyoto University Hospital

Division name

Respiratory Medicine

Zip code


Address

54 Shogoin-Kawaharacho, Sakyoku, Kyoto, Japan

TEL

075-751-3830

Homepage URL


Email

hwithe@kuhp.kyoto-u.ac.jp


Sponsor or person

Institute

Kyoto Thoracic Oncology Research Group

Institute

Department

Personal name



Funding Source

Organization

Ministry of Education, Culture, Sports, Science and Technology

Organization

Division

Category of Funding Organization

Japanese Governmental office

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

京都大学附属病院(京都府)


Other administrative information

Date of disclosure of the study information

2013 Year 01 Month 01 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 11 Month 01 Day

Date of IRB


Anticipated trial start date

2012 Year 12 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

2012 Year 11 Month 10 Day

Last modified on

2017 Year 11 Month 14 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010930


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name