UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000004327
Receipt number R000005012
Scientific Title Phase II Study of induction Carboplatin+Paclitaxel+Bevacizumab combination therapy for stage III Non-Small-Cell Lung Cancer (NSCLC)
Date of disclosure of the study information 2010/10/05
Last modified on 2019/04/20 14:04:59

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Basic information

Public title

Phase II Study of induction Carboplatin+Paclitaxel+Bevacizumab combination therapy for stage III Non-Small-Cell Lung Cancer (NSCLC)

Acronym

Phase II Study of induction Carboplatin+Paclitaxel+Bevacizumab combination therapy for stage III NSCLC
(TCOG1002)

Scientific Title

Phase II Study of induction Carboplatin+Paclitaxel+Bevacizumab combination therapy for stage III Non-Small-Cell Lung Cancer (NSCLC)

Scientific Title:Acronym

Phase II Study of induction Carboplatin+Paclitaxel+Bevacizumab combination therapy for stage III NSCLC
(TCOG1002)

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 of preoperative
Carboplatin+Paclitaxel+Bevacizumab combination therapy followed by surgery for stage III Non-Squamous Non-Small-Cell Lung Cancer

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase

Phase II


Assessment

Primary outcomes

ORR

Key secondary outcomes

2 year survival rate
Complete resection rate
RFS
DFS
PFS
pRR
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

CBDCA AUC=6(day1)+
Paclitaxel 200mg/m2(day1)+
Bevacizumab 15mg/kg (day1)
q3weeks 2cycles

CBDCA AUC=6(day1)+
Paclitaxel 200mg/m2(day1)+
q3weeks 1cycles

Surgical operation is performed over 5 weeks after chemotherapy

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 cytologically confirmed non-squamous non-small cell lung cancer(NSCLC)
2)Patients with stage IIIa or IIIb(UICC-7)However,"T3N1"is excluded
3)Patients with measurable lesion(RECIST ver.1.1)
4)Age:20-74years old
5)ECOG PS 0-1
6)Patients without previous treatment for NSCLC
7)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
8)Sufficient organ function
neutro>=1500/mm3
Plt >=100000/mm3
Hb >=9.0g/dl
T-bil <= 1.5mg/dl
GOT/GPT <= 99IU/L
Cr >= 1.5mg/dl
SpO2 >= 95% or PaO2>=70mmHG
FEV1.0 >=1.0L
PT-INR<=1.5
Proteinuria <=1+
9)Patients are expected to live over 3 months
10)Written IC

Key exclusion criteria

1)History of active double cancer within 5 years
2)Overt infection
3)History of hemoptysis
4)With great vessel invasion
5)Cavity in tumor
6)Receiving anticoagulant drug(except Aspirin within 324mg/day)
7)Uncontrollable Gastrointestinal ulceration
8)Current or previous(within the last 1 year)history of GI perforation
9)Severe cardiac disease
10)History of Arterial thromboembolism within 1year
11)Interstitial pneumonia or pulmonary fibrosis detectable on X-ray
12)Peripheral neuropathy > Grade2
13)Major surgical procedure
14)With a history of drug sensitivity
15)History of pregnancy or lactation
16)No intention to practice birth control
17)Patients whose participation in the trial is judged to be inappropriate by the attending doctor

Target sample size

25


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Norihiko Ikeda

Organization

Tokyo medical university

Division name

First department of surgery

Zip code


Address

6-1-1 Shinjuku Shinjuku-ku Tokyo, Japan

TEL

03-3342-6111

Email

tcog-lc@tcog.jp


Public contact

Name of contact person

1st name
Middle name
Last name TCOG Lung Cancer affairs office

Organization

The Tokyo Cooperative Oncology Group

Division name

Clinical Study Promotion Agency

Zip code


Address

Toa BLDG. 4F 2-1-18 Hamamatsu-cho Minato-ku Tokyo, Japan

TEL

03-5401-5020

Homepage URL


Email

tcog-lc@tcog.jp


Sponsor or person

Institute

The Tokyo Cooperative Oncology Group

Institute

Department

Personal name



Funding Source

Organization

The Tokyo Cooperative Oncology Group

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


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

東京医科大学
癌研有明病院
北里大学
熊本大学
千葉県がんセンター
千葉大学


Other administrative information

Date of disclosure of the study information

2010 Year 10 Month 05 Day


Related information

URL releasing protocol


Publication of results

Partially published


Result

URL related to results and publications

http://abstracts.asco.org/144/AbstView_144_126651.html

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

Completed

Date of protocol fixation

2010 Year 09 Month 17 Day

Date of IRB

2010 Year 08 Month 31 Day

Anticipated trial start date

2011 Year 03 Month 01 Day

Last follow-up date

2014 Year 05 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded

2018 Year 12 Month 31 Day


Other

Other related information



Management information

Registered date

2010 Year 10 Month 05 Day

Last modified on

2019 Year 04 Month 20 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005012


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name