UMIN-CTR Clinical Trial

Public title

A phase II study of combination chemotherapy with carboplatin plus S-1 in advanced lung squamous cell carcinoma

Acronym

Phase II study of S-1continuation maintenance therapy following CBDCA/S-1 in lung squamous cell carcinoma NSCLC :S-COT

Scientific Title

A phase II study of combination chemotherapy with carboplatin plus S-1 in advanced lung squamous cell carcinoma

Scientific Title:Acronym

Phase II study of S-1continuation maintenance therapy following CBDCA/S-1 in lung squamous cell carcinoma NSCLC :S-COT

Region

Japan

Condition

Lung cancer

Classification by specialty

Pneumology

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

The objective of this study is to examine the efficacy and safety of combination chemotherapy with S-1 and carboplatin in advanced lung squamous cell carcinoma

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II

Primary outcomes

Progression free survival

Key secondary outcomes

Overall survival,
1-year survival Rate,
Response Rate,
Safety

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Patients receive 4 courses of CBDCA/S-1.
Chemotherapy with S-1 is continued for patients who do not have PD

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

Age-lower limit

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1) Histologically or pathologically proven lung squamous cell carcinoma
2) Locally advanced or metastatic, recurrent non-small cell lung cancer
3) Age more than 20 years
4) Performance status (ECOG) of 0-1
5) Life expectancy of more than 3 months
6) Patients with ability of oral intake
7) Patients who has at least one or more measurable lesion by RECIST
8) Patients who have adequate organ function
9) Written informed consent

Key exclusion criteria

1) Patients who received previous treatment with the 5-FU
2) Patients who is contraindicated to administration of CBDCA and S-1
3) Patients with a history of the drug hypersensitivity
4) Patients with symptomatic metastases to brain
5) Uncontrolled massive pleural effusion, ascitic fluid and pericardial fluid retention case
6) Patients with watery diarrhea
7) Patients with serious complications
8) Patients with active concomitant malignancy
9) Patients with HBs antigen-positive or with HCV antibody-positive
10) Patients who uses flucytosine
11) Women with the pregnant possibility, a pregnancy or lactation and men with willing to get pregnant
12) Patients who were complicated with mental disease or neurologic manifestation, and it is judged that the participation in study is difficult
13) Any other cases who are regarded as inadequate for study enrollment by the investigator.

Target sample size

50

Name of lead principal investigator

1st name
Middle name
Last name	Kingo Chida

Organization

Hamamatsu University School of Medicine

Division name

The Second Division, Department of Internal Medicine

Zip code

Address

1-20-1, Handayama, Higashi-ku, Hamamatsu City 431-3192, Shizuoka Prefecture, Japan

TEL

Email

Name of contact person

1st name
Middle name
Last name	Yasuhiro Ito

Organization

Hamamatsu University School of Medicine

Division name

The Second Division, Department of Internal Medicine

Zip code

Address

1-20-1, Handayama, Higashi-ku, Hamamatsu City 431-3192, Shizuoka Prefecture, Japan

TEL

Homepage URL

Email

Institute

Hamamatsu University School of Medicine

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

浜松医科大学付属病院（静岡県）
浜松医科大学呼吸器内科グループ

Date of disclosure of the study information

2012

Year

01

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Completed

Date of protocol fixation

2011

Year

11

Month

14

Day

Date of IRB

Anticipated trial start date

2012

Year

01

Month

01

Day

Last follow-up date

2015

Year

12

Month

01

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2011

Year

12

Month

28

Day

Last modified on

2016

Year

06

Month

10

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008237