UMIN-CTR Clinical Trial

Public title

The Utility of PET/CT in gofitinib treatment for Non-small Cell Lung Cancer

Acronym

The Utility of PET/CT in gofitinib treatment for Non-small Cell Lung Cancer

Scientific Title

The Utility of PET/CT in gofitinib treatment for Non-small Cell Lung Cancer

Scientific Title:Acronym

The Utility of PET/CT in gofitinib treatment for Non-small Cell Lung Cancer

Region

Japan

Condition

Non-Small Cell Lung Cancer

Classification by specialty

Pneumology	Hematology and clinical oncology	Radiology

Classification by malignancy

Malignancy

Genomic information

YES

Narrative objectives1

To evaluate whether the change of FDG uptake 2 days after gefitinib administration can predict the overall response of gefitinib for NSCLC

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable

Primary outcomes

Relationship between uptake of FDG 2days after gefitinib administration and tumor size on CT

Key secondary outcomes

PFS, OS, Rekationship between uptake of FDG 2days after gefitinib administration and EGFR mutation status

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

Device,equipment

Interventions/Control_1

PET/CT 2days after gefitinib administration

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)Treatment with gefitinib
3)At least one measurable lesion
4)Age>20years
5)Perfomance status(PS)of 0 to 2
6)Written informed consent

Key exclusion criteria

1)History of radiation therapy for primary site
2)Severe infection
3)Bowel obstruction
4)Interstital pneumonia or lung fibrosis
5)History of any thoracic radiation therapy
6)Active concmitant malignancy
7)Severe heart disease
8)No regulatory condition because of psychological disease
9)Pregnancy or women willing child-bearing
10)Inadequate condition diagosed by primary physician

Target sample size

20

Name of lead principal investigator

1st name
Middle name
Last name	Isao Tachibana

Organization

Osaka University Graduate School of Medicine

Division name

Department of Respiratory medicine, Allergy and Rheumatic Diseases

Zip code

Address

2-2 Yamadaoka, Suita, Osaka

TEL

06-6879-3831

Email

Name of contact person

1st name
Middle name
Last name	Isao Tachibana

Organization

Osaka University Graduate School of Medicine

Division name

Department of Respiratory medicine, Allergy and Rheumatic Diseases

Zip code

Address

2-2 Yamadaoka, Suita, Osaka

TEL

06-6879-3831

Homepage URL

http://clincancerres.aacrjournals.org/content/early/2011/10/21/1078-0432.CCR-11-0868.long

Email

itachi02@imed3.med.osaka-u.ac.jp

Institute

Department of Respiratory medicine, Allergy and Rheumatic Diseases, Osaka University Graduate School of Medicine

Institute

Department

Personal name

Organization

none

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Japan

Co-sponsor

Department of Nuclear Medicine, Osaka University Graduate School of Medicine

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

大阪大学医学部附属病院

Date of disclosure of the study information

2010

Year

05

Month

17

Day

URL releasing protocol

http://clincancerres.aacrjournals.org/content/early/2011/10/21/1078-0432.CCR-11-0868.long

Publication of results

Published

URL related to results and publications

http://clincancerres.aacrjournals.org/content/early/2011/10/21/1078-0432.CCR-11-0868.long

Number of participants that the trial has enrolled

Results

At 2 days of gefitinib treatment, 10 patients (50%) showed metabolic response, 8 were metabolic stable disease, and 2 had progressive metabolic disease. Percent changes of SUV at 2 days were correlated with those of tumor size in CT at 1 month (R2 = 0.496; P = 0.0008). EGFR gene was assessable in 15 patients and, of 12 patients with EGFR mutations, 8 showed metabolic response at 2 days and 6 showed morphologic response at 1 month. None of 3 patients with wild-type EGFR showed metabolic or morphologic response. Metabolic response at 2 days was not statistically associated with PFS (P = 0.095), but when a cutoff of -20% in SUV decline was used, metabolic responders had longer PFS (P < 0.0001).

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

2007

Year

11

Month

13

Day

Date of IRB

Anticipated trial start date

2007

Year

12

Month

01

Day

Last follow-up date

2010

Year

11

Month

01

Day

Date of closure to data entry

2010

Year

11

Month

01

Day

Date trial data considered complete

2010

Year

11

Month

01

Day

Date analysis concluded

2010

Year

11

Month

01

Day

Other related information

Registered date

2010

Year

05

Month

16

Day

Last modified on

2011

Year

12

Month

17

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004388