UMIN-CTR Clinical Trial

Public title

Phase II Study of Nedaplatin+TS-1 for previously untreated patients with squamous cell lung cancer

Acronym

Phase II Study of CDGP+TS-1 for previously untreated patients with squamous cell lung cancer

Scientific Title

Phase II Study of Nedaplatin+TS-1 for previously untreated patients with squamous cell lung cancer

Scientific Title:Acronym

Phase II Study of CDGP+TS-1 for previously untreated patients with squamous cell lung cancer

Region

Japan

Condition

Squamous cell lung cancer

Classification by specialty

Pneumology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

Phase II Study of Nedaplatin+TS-1 for previously untreated patients with squamous cell lung cancer

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Phase II

Primary outcomes

Response rate

Key secondary outcomes

Overall survival
Progression free survival
Time to responce
Safety
QoL

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

Nedaplatin 80mg/m2 d1 q3w until PD
TS-1 was administered at fixed dose based on the body surface area(BSA) of the patient.
BSA<1.25 m2 80mg/day
BSA 1.25-1.5 m2 100mg/day
BSA>1.5 m2 150mg/day
d1-14 q3w until 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

80

years-old

>=

Gender

Male and Female

Key inclusion criteria

1)Histologivally confirmed Stage3B/4 squamous cell lung cancer.

2)Patients who previously untreated whit systemic chemotherapy.

3)With one or more measurable disease based on Response Evaluation Criteria In SolidTumors(RECIST)ver1.1.

4)No radiotherapy other than thoracic radiation within 2 weeks
No operation within 4 weeks
No pleuodesis,pleural drainage etc.within 2 weeks
No aspiration biopsy cytology within 1 weeks

5)Eastern Cooperative Oncology Group(ECOG)Performance Status of 0-2.

6)Adequate function of vital organs,including normal hematopoietic function,normal liver function and normal renal function as evidenced by the following data.

Neutrocyte>=155/mm3
Hemoglobin>=9.0g/dL
Platelet count>=75,000/mm3
Aspartate aminotransferase and alanine aminotransferase<100IU/I
Total bilirubin<=1.5mg/dL
Serum creatinine<=1.5mg/dL
PT-INR<1.5
Urine protein<=+1
SpO2>=90%

7)A life expectancy of more than 3 months.

8)all patuebts provided written informed consent before initiation of study-related procedures.

Key exclusion criteria

History of active double cancer within 5 years.
2) Severe infection
3) History of hemoptysis with 2.5mL or more.
4) Continued bloody phlegm.
5) Received anticoagulant drug(including Aspirin over 325mg/day) within the past 10 days.
6) Perforation of the digestive tract or history of the perforation of the digestive tract within the past one year.
7) Severe comorbidity (heart failure Tendency to hemorrhages uncontrollable hypertension, uncontrollable diabetes, etc)
8) Arterial thromboembolism and Venous thromboembolism within the past one year.

9)Interstitial pneumonia or pulmonary fibrosis detectable on X ray.

10) Planning of surgery or thoracic radiotherapy during the trial.

11) Major surgical procedure
12)With a history of drug sensitivity.
13)Pregnant or lactating women or those who declined contraception.
14) Any other medical condition that makes the patient unsuitable for inclusion in the study according to the opinion of the investigator.

Target sample size

25

Name of lead principal investigator

1st name
Middle name
Last name	Yasuo Matsuzawa

Organization

Toho university

Division name

Division of Pneumology

Zip code

Address

564-1 Shimoshizu Sakura City, Chiba Prefecture 285-8741

TEL

Email

Name of contact person

1st name
Middle name
Last name

Organization

Toho university

Division name

Division of Pneumology

Zip code

Address

564-1 Shimoshizu Sakura City, Chiba Prefecture 285-8741

TEL

Homepage URL

Email

Institute

Toho university

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

東邦大学医療センター佐倉病院(千葉県)

Date of disclosure of the study information

2012

Year

12

Month

17

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

Open public recruiting

Date of protocol fixation

2012

Year

12

Month

17

Day

Date of IRB

Anticipated trial start date

2013

Year

01

Month

01

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2012

Year

12

Month

14

Day

Last modified on

2012

Year

12

Month

14

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010950