UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000008817
Receipt number R000010364
Scientific Title A Study on the efficacy of neoadjuvant chemotherapy with carboplatin, docetaxel and bevacizumab in patients with non-squamous non-small cell lung cancer
Date of disclosure of the study information 2012/09/01
Last modified on 2014/09/10 17:04:52

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Basic information

Public title

A Study on the efficacy of neoadjuvant chemotherapy with carboplatin, docetaxel and bevacizumab in patients with non-squamous non-small cell lung cancer

Acronym

A Study on the efficacy of neoadjuvant chemotherapy with carboplatin, docetaxel and bevacizumab in patients with non-squamous non-small cell lung cancer

Scientific Title

A Study on the efficacy of neoadjuvant chemotherapy with carboplatin, docetaxel and bevacizumab in patients with non-squamous non-small cell lung cancer

Scientific Title:Acronym

A Study on the efficacy of neoadjuvant chemotherapy with carboplatin, docetaxel and bevacizumab in patients with non-squamous non-small cell lung cancer

Region

Japan


Condition

Condition

Non-Squamous Non-Small Cell Lung Cancer

Classification by specialty

Pneumology Chest surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

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

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase



Assessment

Primary outcomes

Pathological complete resection rate

Key secondary outcomes

Pathological response rate (pRR)
Complete resection rate
Relapse-free survival (RFS)
Overall survival (OS)
Safety


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine Maneuver

Interventions/Control_1

Carboplatin + Docetaxel + Bevacizumab
day1 q3w 2cycles

Surgical operation is performed over 5 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



Eligibility

Age-lower limit

20 years-old <=

Age-upper limit

75 years-old >

Gender

Male and Female

Key inclusion criteria

1) Histologically or pathologically confirmed non-squamous non-small cell lung cancer
2) Clinical stage IB- IIIA
3) Age:20-74years old
4) ECOG PS 0-1
5) Patients without previous treatment for lung cancer
6) If the patient underwent therapy, there should be the following interval between the therapy and the registration
-Open biopsy,Treatment of injury->2 weeks
-Aspiration biopsy,->1 week
7) Sufficient organ function
8) Written IC

Key exclusion criteria

1) History of severe drug allergy
2) Patients with uncontrollable complications
3) Patients with symptomatic Brain metastasis
4) History of hemoptysis ( >= 2.5mL)
5) History of continuous hemosputum
6) Patients with massive pleural and cardiac effusion
7) Patients with uncontrollable peptic ulcer
8) History of myocardial infarction or cerebral infarction
9) Current or previous history of GI perforation
10) Patients with therapeutic anticoagulopathy
11) Pregnancy, breast feeding and suspected pregnancy
12) Active concomitant malignancy
13) Inappropriate patients for this study judged by the physicians

Target sample size

28


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Motohiko Furuichi

Organization

Nihon University School of Medicine Itabashi Hospital

Division name

Department of respiratory surgery

Zip code


Address

30-1 Ohyaguchi kami-machi, Itabashi-ku, Tokyo

TEL

03-3972-8111

Email

furuichi.motohiko@nihon-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Motohiko Furuichi

Organization

Nihon University School of Medicine Itabashi Hospital

Division name

Department of respiratory surgery

Zip code


Address

30-1 Ohyaguchi kami-machi, Itabashi-ku, Tokyo

TEL

03-3972-8111

Homepage URL


Email

furuichi.motohiko@nihon-u.ac.jp


Sponsor or person

Institute

Nihon University School of Medicine Itabashi Hospital

Institute

Department

Personal name



Funding Source

Organization

Nihon University School of Medicine Itabashi Hospital

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor

Kawaguchi Municipal Medical Center

Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2012 Year 09 Month 01 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

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



Progress

Recruitment status

Enrolling by invitation

Date of protocol fixation

2012 Year 02 Month 28 Day

Date of IRB


Anticipated trial start date

2012 Year 06 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2012 Year 08 Month 31 Day

Last modified on

2014 Year 09 Month 10 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010364


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name