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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004327
Receipt No. 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

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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
Institute The Tokyo Cooperative Oncology Group
Institute
Department

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
URL(English) https://upload.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


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