UMIN-CTR Clinical Trial

Public title

Phase III study of gefitinib versus erlotinib in patients with previously treated lung adeno carcinoma

Acronym

gefitinib versus erlotinib in patients with previously treated lung adeno carcinoma (WJOG5108)

Scientific Title

Phase III study of gefitinib versus erlotinib in patients with previously treated lung adeno carcinoma

Scientific Title:Acronym

gefitinib versus erlotinib in patients with previously treated lung adeno carcinoma (WJOG5108)

Region

Japan

Condition

Previously treated lung adeno carcinoma

Classification by specialty

Pneumology

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To compare the efficacy of gefitinib with erlotinib in previously treated lung adeno carcinoma.

Basic objectives2

Bio-equivalence

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase III

Primary outcomes

Progression free survival

Key secondary outcomes

Overall survival, Response rate, disease control rate, Toxicity, Time to treatment failure,

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

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

A: Reference arm
Erlotinib monotherapy

Interventions/Control_2

B: Experimental arm
Gefitinib monotherapy

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)Patients with lung cancer which was pathologically proven adenocarcinoma.
2)Patients with stage IIIb or IV who heve previously treated one or more chemotherapy.
*Adjuvant and neo-adjuvant chemotherapy
are not considered as one regimen of chemotherapy.
*Oral agents except for TS-1 are not considered as one regimen of chemotherapy.
3).Patients with evaluable disease (not necessarily to be measurable)
4)7.Age eligible for study: 20 years and above
5)ECOG PS 0-2
6)Sufficient organ function
WBC>=3000/mm3
Plt >=75000/mm3
GOT/GPT <=100IU/L
T-bil=<1.5mg/dl
Cr. =<1.2mg/dL
SpO2>=95% or PaO2>=60%
7)No prior drug therapy targeting EGFR (TKI, Abs) .
8)Patients are expected to live over 12 weeks.
9)Written informed consent

Key exclusion criteria

1)History of obvious and widely distributed interstitial pneumonia or pulmonary fibrosis detected by chest CT
2)History of drug induced interstitial pneumonia
3)History of severe drug allergy
4)History of radiation therapy for mediastinum or lung within 14 days at the time of entry. (Radiation therapy for other parts is not adapted for this exclusion cliteria.)
5)History of poorly controlled pleural effusion, pericardial effusion or ascites necessitating drainage
6)History of active infection
7)History of persistent watery diarrhea
8)History of ileus
9)Patients who are not take in drug orally
10)History of symptomatic brain metastases.
11)History of active double cancer
12)History of poorly controlled cardiac diseases.
13)History of active psychological disease.
14) History of pregnancy or lactation
15) Patients whose participation in the trial is judged to be inappropriate by the attending doctor

Target sample size

560

Name of lead principal investigator

1st name
Middle name
Last name	Yoshiko Urata

Organization

Hyogo Cancer Center

Division name

Thoracic Oncology

Zip code

Address

13-70 Kitaoji &#8211;cho, Akasi-city, Hyogo.

TEL

078-929-1151

Email

urata@hp.pref.hyogo.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

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

Date of disclosure of the study information

2009

Year

06

Month

19

Day

URL releasing protocol

Publication of results

Published

URL related to results and publications

http://www.ncbi.nlm.nih.gov/pubmed/27022112

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

06

Month

01

Day

Last follow-up date

2013

Year

10

Month

12

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2009

Year

05

Month

29

Day

Last modified on

2016

Year

03

Month

31

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002455