UMIN-CTR Clinical Trial

Public title

A PhaseII Study of Bevacizumab in Combination with S-1 in Patients with Non-Squamous Non-Small-Cell Lung Cancer
reviously treated with platinum based chemotherapy

Acronym

A PhaseII Study of Bevacizumab in Combination with S-1 in Patients with Non-Squamous Non-Small-Cell Lung Cancer
reviously treated with platinum based chemotherapy

Scientific Title

A PhaseII Study of Bevacizumab in Combination with S-1 in Patients with Non-Squamous Non-Small-Cell Lung Cancer
reviously treated with platinum based chemotherapy

Scientific Title:Acronym

A PhaseII Study of Bevacizumab in Combination with S-1 in Patients with Non-Squamous Non-Small-Cell Lung Cancer
reviously treated with platinum based chemotherapy

Region

Japan

Condition

Non-Squamous Non-Small-Cell Lung Cancer

Classification by specialty

Pneumology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To evaluate the efficacy and safety of Bevacizumab in combination with S-1 for patients previously treated with combining chemotherapy.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II

Primary outcomes

Response rate

Key secondary outcomes

progression free survival,time to treatment failur,overall survival,and safety

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

S-1: 40 mg/m2 twice daily(orally, day1 after dinner ; day15 after breakfast)
Bevacizumab: 15mg/kg day 1
The treatment is repeated every three weeks until disease progression or severe toxicity.

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

75

years-old

>=

Gender

Male and Female

Key inclusion criteria

(1) Histologically proven non-squamous non-small cell lung cancer
(2) Written informed consent after the explanation of the content of the examination
(3) Age:20-74 years old
(4) ECOG performance status of 0-1
(5) Life expectancy more than 3 months
(6) Adequate organ functions
1.Neutrophil ->2,000 /mm3
2.Platelet -> 100,000 /mm3
3.Hemoglobin concentration -> 9.0 g/dl
4.Total bilirubin <- 1.5 mg/dl
5.AST or ALT <- 100IU/l
6.Cr <= 1.5 mg/dl

Key exclusion criteria

(1) Previously untreated with platinum doublet
(2) transfusion or G-CSF within 2weeks prior to enrollment
(3) Severe renal function disorder, 2+ or higher proteinuria within 2 weeks prior to enrollment
(4) History of severe drug allergy
(5) History of active double cancer within 5 years
(6) History of active severe infections
(7) Patients who have fever of over 38 degrees
(8) Continuous administration of steroid drug
(9) Severe cardiac disease
(10) History of thromboembolism or severe pulmonary disease
(11) History of GI bleeding,ileus,GI ulceration
(12) massive pleural or pericardial effusion,ascites
(13) Symptomatic brain metastases
(14) Uncontrollable hypertension or diabetes mellitus
(15) Uncontrollable diarrhea
(16) Wound of unrecovery
(17) Traumatic fracture of unrecovery
(18) bleeding diathesis or receiving anticoagulant drug(except Aspirin under 324mg/day)
(19) History of pregnancy or lactation
(20) Evaluated to be ineligible by a physician for other reasons

Target sample size

34

Name of lead principal investigator

1st name
Middle name
Last name	Yasuo Iwamoto

Organization

Hiroshima citizens hospital

Division name

Department of Medical Oncology

Zip code

Address

7-35 Motomachi , Naka-ku, Hiroshima, 730-8518, Japan

TEL

Email

Name of contact person

1st name
Middle name
Last name	Yasuo Iwamoto

Organization

Hiroshima citizens hospital

Division name

Department of Medical Oncology

Zip code

Address

7-35 Motomachi , Naka-ku, Hiroshima, 730-8518, Japan

TEL

Homepage URL

Email

Institute

Hiroshima citizens hospital
Department of Medical Oncology

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

2011

Year

04

Month

22

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

Open public recruiting

Date of protocol fixation

2010

Year

05

Month

10

Day

Date of IRB

Anticipated trial start date

2010

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

04

Month

22

Day

Last modified on

2011

Year

04

Month

26

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006510