UMIN-CTR Clinical Trial

Public title

A randomized phase II study of TS-1+Cisplatin versus Vinorelbine+Cisplatin,with thoracic radiotherapy for locally advanced non-small cell lung cancer.

Acronym

A randomized phase II study of TS-1+Cisplatin versus Vinorelbine+Cisplatin,with thoracic radiotherapy for locally advanced non-small cell lung cancer.

Scientific Title

A randomized phase II study of TS-1+Cisplatin versus Vinorelbine+Cisplatin,with thoracic radiotherapy for locally advanced non-small cell lung cancer.

Scientific Title:Acronym

A randomized phase II study of TS-1+Cisplatin versus Vinorelbine+Cisplatin,with thoracic radiotherapy for locally advanced non-small cell lung cancer.

Region

Japan

Condition

Non-small cell lung cancer

Classification by specialty

Pneumology	Endocrinology and Metabolism	Radiology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To assess the efficacy and safety of TS-1+Cisplatin or Vinorelbine+Cisplatin,with thoracic radiotherapy for locally advanced non-small cell lung cancer.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II

Primary outcomes

2 year survival rate

Key secondary outcomes

Over all survival, Progression free survival, Compliance rate of protocol regimen, Adverse event

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

YES

Dynamic allocation

YES

Institution consideration

Institution is considered as adjustment factor in dynamic allocation.

Blocking

Concealment

Central registration

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

TS-1+Cisplatin+ radiation

Interventions/Control_2

VNR+ Cisplatin+ radiation

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

75

years-old

>

Gender

Male and Female

Key inclusion criteria

-Histologically or cytologically confirmed NSCLC
-No prior chemotherapy, radiotherapy or surgery (Open biopsy is allowed).
-Unresectable lung cancer Stage 3A
or 3B.
-V20 <= 35%
-Oral intake is possible
-Adult patients (>=20,<75 years of age)
-ECOG performance status 0 or 1
-Adequate organ function.
-Laboratory values must be as follows;
WBC count >= 4,000/mm3,
Neutrophil count >= 2,000/mm3
hemoglobin >= 9.5g/dL,
Platelet count >= 100,000/mm3
AST and ALT <= 100IU/LBilirubine level <= 1.5 mg/dL,
Serum creatinine <= 1.5 mg/dL
Creatinine clearance >= 60 mL/min,
PaO2 >= 70 torr
-Patients must sign an informed consent.

Key exclusion criteria

-T3N1
-SVC syndrome.
-Clinically significant pleural or
pericardial effusion,Contralateral
Hilar lymph node metastasis,
-Patients with concurrent serious
infections or complications
-Continuous watery diarrhea
-Paralysis of the intestine, or ileus
-Significant interstitial pneumonitis
,pulmonary fibrosis or severe emphysema
in Chest Xp
-The presence of other concomitant cancers
-Concomitant therapy with another
new anticancer drug, phenytoin,
warfarin or flucytocine
-Inadequately controlled diabetes
mellitus
-HBs Ag is positive
-A history of serious drug allergy
-Mental disease or psychotic
manifestation
-Pregnancy,breast feeding or wish of
future bearing
-Other conditions not suitable for this
study

Target sample size

110

Name of lead principal investigator

1st name
Middle name
Last name	Tomonari Sasaki

Organization

Graduate School of Medical Sciences Kyushu University

Division name

Department of Radiology

Zip code

Address

3-1-1 Maidashi, Higashi-ku, Fukuoka, 812-8582, Japan

TEL

092-642-5378

Email

tomonari@radiol.med.kyushu-u.ac.jp

Name of contact person

1st name
Middle name
Last name	Shinichiro Nakamura

Organization

West Japan Oncology Group

Division name

WJOG datacenter

Zip code

Address

Namba Plaza Bldg.3F 1-5-7,Motomachi Naniwa-ku,Osaka556-0016 JAPAN

TEL

06-6633-7400

Homepage URL

Email

datacenter@wjog.jp

Institute

West Japan Oncology Group

Institute

Department

Personal name

Organization

TAIHO PHARMACEUTICAL CO.,LTD

Organization

Division

Category of Funding Organization

Profit organization

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

Date of disclosure of the study information

2009

Year

09

Month

10

Day

URL releasing protocol

Publication of results

Published

URL related to results and publications

https://www.ncbi.nlm.nih.gov/pubmed/30206369

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

2009

Year

05

Month

23

Day

Date of IRB

Anticipated trial start date

2009

Year

09

Month

01

Day

Last follow-up date

2014

Year

09

Month

01

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2009

Year

09

Month

01

Day

Last modified on

2018

Year

09

Month

18

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002965