UMIN-CTR Clinical Trial

Public title

Phase II Study of neoadjuvant chemotherapy with carboplatin,pemetrexed and bevacizumab in patients with non-squemous non-small-cell lung cancer

Acronym

Phase II Study of neoadjuvant chemotherapy with carboplatin,pemetrexed and bevacizumab in patients with non-squemous non-small-cell lung cancer

Scientific Title

Phase II Study of neoadjuvant chemotherapy with carboplatin,pemetrexed and bevacizumab in patients with non-squemous non-small-cell lung cancer

Scientific Title:Acronym

Phase II Study of neoadjuvant chemotherapy with carboplatin,pemetrexed and bevacizumab in patients with non-squemous non-small-cell lung cancer

Region

Japan

Condition

Non-squamous,non-small-cell lung cancer

Classification by specialty

Pneumology	Hematology and clinical oncology	Surgery in general
Chest surgery

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To evaluate the efficacy and safety of neoadjuvant chemotherapy with carboplatin,pemetrexed and bevacizumab in patients with inoperable non-squemous non-small-cell lung cancer

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Phase II

Primary outcomes

Down staging rate

Key secondary outcomes

2year survival rate,2-years relapse free survival,Progression free survival,rate of completion of the protocol treatment,Pathologic complete response rate,Complete resection rate,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

Maneuver

Interventions/Control_1

CBDCA AUC6(day1)+Pemetrexed 500mg/m2(day1)+Bevacizumab 15mg/kg(day1)
q3weeks x2cycles
CBDCA AUC6(day1)+
Pemetrexed 500mg/m2 (day1)
q3weeks x1cycles

Surgical operation is performed over 3 weeks after protocol therapy.

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 or cytologically proven non-squamous non small cell lung cancer
2)Patients with StageII(exclusing N0)/III
3)Without previously treatment for lung cancer
4)ECOG Performance status 0-1
5)Age:20 years to less than 75 years
6)Patients who has measurable by RECIST(ver 1.1)criteria
7)Adequate organ function
8)Life expectancy more than 3 months
9)Signed written informed consent

Key exclusion criteria

1)Uncontrolled infection or Serious medical complications
2)Uncontrollable diabetes mellitus
3)Uncontrollable hypertension
4)Therapeutic anticoagulopathy (except Aspirin within 325mg/day)
5)Current or previous history of hemoptysis
6)Evidence of bleeding diathesis or hemoptysis
7)With great vessel invasion
8)Cavity in tumor
9)Uncontrollable gastrointestinal ulceration
10)Current or previous(within the last 1 year) history of GI perforration
11)History of severe heart disease
12)Interstitial pneumonia or pulmonary fibrosis detectableon chest X-ray
13)Multiple primary cancer
14)With a history of drug sensitivity
15)Patients who do not want to take vitamin preparation
16)Serious psychiatric illness or psychological symptom
17)Women who are pregnant, lactating or with childbearing potential
18)Ineligible based on decision of an investigator.

Target sample size

30

Name of lead principal investigator

1st name
Middle name
Last name	Yukio Sato

Organization

University of Tsukuba

Division name

Faculty of Medicine, Department of Thoracic Surgery

Zip code

Address

1-1-1 Tennodai,Tsukuba 305-8575, Japan

TEL

029-853-3097

Email

ysato@md.tsukuba.ac.jp

Name of contact person

1st name
Middle name
Last name	Yukio Sato

Organization

University of Tsukuba

Division name

Faculty of Medicine, Department of Thoracic Surgery

Zip code

Address

1-1-1 Tennodai,Tsukuba 305-8575 Japan

TEL

029-853-3097

Homepage URL

Email

ysato@md.tsukuba.ac.jp

Institute

University of Tsukuba, Faculty of Medicine, Department of Thoracic Surgery

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

11

Month

24

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

Enrolling by invitation

Date of protocol fixation

2011

Year

11

Month

09

Day

Date of IRB

Anticipated trial start date

2011

Year

11

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

11

Month

22

Day

Last modified on

2018

Year

05

Month

28

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007992