UMIN-CTR Clinical Trial

Public title

A randomized phase II study of cisplatin+TS-1 versus cisplatin+docetaxel, with thoracic radiotherapy for locally advanced non-small cell lung cancer (TORG1018)

Acronym

A randomized phase II study of cisplatin+TS-1 versus cisplatin+docetaxel, with thoracic radiotherapy for locally advanced non-small cell lung cancer (TORG1018)

Scientific Title

A randomized phase II study of cisplatin+TS-1 versus cisplatin+docetaxel, with thoracic radiotherapy for locally advanced non-small cell lung cancer (TORG1018)

Scientific Title:Acronym

A randomized phase II study of cisplatin+TS-1 versus cisplatin+docetaxel, with thoracic radiotherapy for locally advanced non-small cell lung cancer (TORG1018)

Region

Japan

Condition

Non-small cell lung cancer

Classification by specialty

Pneumology

Radiology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To investigate efficacy and safety of cisplatin+TS-1 or cisplatin+docetaxel, 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

Developmental phase

Phase II

Primary outcomes

2 year survival rate

Key secondary outcomes

over all survival, progression free survival, adverse events, dose intensity

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

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

cisplatin+TS-1+thoracic radiotherapy

Interventions/Control_2

cisplatin+docetaxel+thoracic radiotherapy

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

1)histologically or cytologically confirmed NSCLC
2)stage III NSCLC with no prior chemotherapy, radiotherapy or surgery (open biopsy is allowed)
3)unresectable lung cancer
4)V20 <=95% or equivalent dose to it
5)oral intake is possible
6)aged 20 years or older, under 75 years
7)ECOG PS 0-1
8)adequate organ function
-WBC count >=4000/mm3
-neutrophil count >=2000/mm3
-hemoglobin >=9.5g/dL
-platelet count >=100000/mm3
-AST and ALT <=100IU/L
-total bilirubine level <=1.5mg/dL
-serum creatinine <=1.5mg/dL
-creatinine clearance >=60mL/min
-PaO2 >=70torr
9)written informed consent

Key exclusion criteria

1)T3N1
2)SVC syndrome with difficulty of a lot of intravenous infusion
3)clinically significant contralateral hilar lymph node metastasis, carcinomatous pericardial or pleural effusion, or carcinomatous lymphangitis
4)concurent serious infection or complications
5)continuous watery diarrhea
6)significant interstitial pneumonitis or pulmonary fibrosis in chest CT
7)concomitant cancers within 5 years
8)concomitant therapy with another new anticancer drug, phenytoin, warfarin or flucytocine
9)inadequately controlled diabetes mellitus
10)HBs Ag is positive
11)a history of serious drug allergy
12)mental disease or psychotic manifestation
13)pregnancy, breast feeding, wish of future bearing or hesitation in contraception
14)other conditions not suitable for this study

Target sample size

110

Name of lead principal investigator

1st name
Middle name
Last name	Hiroaki Okamoto

Organization

Yokohama Municipal Citizen's Hospital

Division name

Department of Respiratory Medicine

Zip code

Address

56, Okazawa-cho, Hodogaya-ku, Yokohama-shi, Kanagawa, Japan

TEL

Email

Name of contact person

1st name
Middle name
Last name	Tsuneo Shimokawa

Organization

Yokohama Municipal Citizen's Hospital

Division name

Department of Respiratory Medicine

Zip code

Address

56, Okazawa-cho, Hodogaya-ku, Yokohama-shi, Kanagawa, Japan

TEL

Homepage URL

http://www.torg.or.jp/

Email

ts00-shimokawa@city.yokohama.jp

Institute

Thoracic Oncology Research Group

Institute

Department

Personal name

Organization

Thoracic Oncology Research Group

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Japan

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

2011

Year

07

Month

18

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

No longer recruiting

Date of protocol fixation

2011

Year

05

Month

24

Day

Date of IRB

Anticipated trial start date

2011

Year

07

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

2011

Year

07

Month

18

Day

Last modified on

2015

Year

01

Month

26

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007088