UMIN-CTR Clinical Trial

Public title

Immunohistochemical analysis of EGFR, HER2 and their phosphorylated status, and Insulin-like growth factor-1 receptor in tumor tissues obtained from non-small cell lung cancer patients treated with gefitinib

Acronym

Immunohistochemical analysis of EGFR, HER2 and their phosphorylated status, and Insulin-like growth factor-1 receptor in tumor tissues obtained from non-small cell lung cancer patients treated with gefitinib

Scientific Title

Immunohistochemical analysis of EGFR, HER2 and their phosphorylated status, and Insulin-like growth factor-1 receptor in tumor tissues obtained from non-small cell lung cancer patients treated with gefitinib

Scientific Title:Acronym

Immunohistochemical analysis of EGFR, HER2 and their phosphorylated status, and Insulin-like growth factor-1 receptor in tumor tissues obtained from non-small cell lung cancer patients treated with gefitinib

Region

Japan

Condition

gefitinib in patients with NSCLC

Classification by specialty

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To determine the relationships between EFGR, HER2, phosphorylated EGFR, phosphorylated HER2, IGF-1R expressions and efficacy of gefitinib in patients with NSCLC

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Phase II

Primary outcomes

Relationships between EFGR, HER2, phosphorylated EGFR, phosphorylated HER2, IGF-1R expressions and efficacy of gefitinib

Key secondary outcomes

Relationships between EFGR, HER2, phosphorylated EGFR, phosphorylated HER2, IGF-1R expressions and disease control rate or safety of gefitinib

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

gefitinib 250mg/m2 EGFR orally per day

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) NSCLC
2) Chemonaive or prior 1-2 regimens of chemotherapy
3) At least one measurable lesion
4) Availability of tissue sample for immunohistochemical analyses
5) Age > 20 years
6) Adequate main organ functions
7) Performance status (PS) of 0 to 2
8) Written informed consent

Key exclusion criteria

1) Gefitinib with concurrently other chemotherapy
2) Need of curable radiation therapy to primary lesion.
3) Need of radiation therapy to the biopsy lesion for tissue samples for immunohistochemical analyses
4) Old tissue sample (before 2 regimens from the gefitinib therapy) for immunohistochemical analyses and no way to gain a new tissue sample
5) No estimation of at least 3 months survival
6) Intestinal pneumonia or lung fibrosis
7) History of severe drug allergic reaction
8) Severe infection and complication (cardio insufficiency or hemorrhage etc.)
9) Severe diarrhea
10) Bowel obstruction
11) Symptomatic brain metastasis
12) History of other malignancy
13) Pregnant women or women willing child-bearing
14) No regulatory condition because of psychological disease
15) Inadequate condition diagnosed by primary physician

Target sample size

100

Name of lead principal investigator

1st name
Middle name
Last name	Kenji Tamura MD

Organization

Kinki University School of Medicine, Nara Hospital

Division name

Department of Medical Oncology

Zip code

Address

Otoda, Ikoma, Nara, 630-0293, Japan

TEL

0743-77-0880

Email

Name of contact person

1st name
Middle name
Last name	Shinichiro Nakamura

Organization

West Japan Oncology Group

Division name

WJOG datacenter

Zip code

Address

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

2005

Year

09

Month

07

Day

URL releasing protocol

Publication of results

Published

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

2003

Year

10

Month

28

Day

Date of IRB

Anticipated trial start date

2003

Year

12

Month

01

Day

Last follow-up date

2007

Year

09

Month

01

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2005

Year

09

Month

07

Day

Last modified on

2016

Year

09

Month

27

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000188