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 |
Phase II Study of induction Carboplatin+Paclitaxel+Bevacizumab combination therapy for stage III Non-Small-Cell Lung Cancer (NSCLC)
Phase II Study of induction Carboplatin+Paclitaxel+Bevacizumab combination therapy for stage III NSCLC
(TCOG1002)
Phase II Study of induction Carboplatin+Paclitaxel+Bevacizumab combination therapy for stage III Non-Small-Cell Lung Cancer (NSCLC)
Phase II Study of induction Carboplatin+Paclitaxel+Bevacizumab combination therapy for stage III NSCLC
(TCOG1002)
Japan |
Non-Squamous Non-Small-Cell Lung Cancer
Pneumology | Chest surgery |
Malignancy
NO
To evaluate the efficacy of preoperative
Carboplatin+Paclitaxel+Bevacizumab combination therapy followed by surgery for stage III Non-Squamous Non-Small-Cell Lung Cancer
Safety,Efficacy
Phase II
ORR
2 year survival rate
Complete resection rate
RFS
DFS
PFS
pRR
Safety
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine | Maneuver |
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
20 | years-old | <= |
75 | years-old | > |
Male and Female
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
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
25
1st name | |
Middle name | |
Last name | Norihiko Ikeda |
Tokyo medical university
First department of surgery
6-1-1 Shinjuku Shinjuku-ku Tokyo, Japan
03-3342-6111
tcog-lc@tcog.jp
1st name | |
Middle name | |
Last name | TCOG Lung Cancer affairs office |
The Tokyo Cooperative Oncology Group
Clinical Study Promotion Agency
Toa BLDG. 4F 2-1-18 Hamamatsu-cho Minato-ku Tokyo, Japan
03-5401-5020
tcog-lc@tcog.jp
The Tokyo Cooperative Oncology Group
The Tokyo Cooperative Oncology Group
Self funding
NO
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
2010 | Year | 10 | Month | 05 | Day |
Partially published
http://abstracts.asco.org/144/AbstView_144_126651.html
Completed
2010 | Year | 09 | Month | 17 | Day |
2010 | Year | 08 | Month | 31 | Day |
2011 | Year | 03 | Month | 01 | Day |
2014 | Year | 05 | Month | 01 | Day |
2018 | Year | 12 | Month | 31 | Day |
2010 | Year | 10 | Month | 05 | Day |
2019 | Year | 04 | Month | 20 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005012