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
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
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
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
