UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004524 |
|---|---|
| Receipt number | R000005011 |
| Scientific Title | Phase II Study of Carboplatin +Docetaxel +Bevacizumab in Chemo-Naive Patients with stage IIIB and IV Non-Squamous Non-Small-Cell Lung Cancer |
| Date of disclosure of the study information | 2010/11/09 |
| Last modified on | 2014/12/04 10:08:52 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Phase II Study of Carboplatin +Docetaxel +Bevacizumab in Chemo-Naive Patients with stage IIIB and IV Non-Squamous Non-Small-Cell Lung Cancer
Acronym
Phase II Study of Carboplatin +Docetaxel +Bevacizumab in Chemo-Naive Patients with stage IIIB and IV Non-Squamous Non-Small-Cell Lung Cancer
(TCOG 1001)
Scientific Title
Phase II Study of Carboplatin +Docetaxel +Bevacizumab in Chemo-Naive Patients with stage IIIB and IV Non-Squamous Non-Small-Cell Lung Cancer
Scientific Title:Acronym
Phase II Study of Carboplatin +Docetaxel +Bevacizumab in Chemo-Naive Patients with stage IIIB and IV Non-Squamous Non-Small-Cell Lung Cancer
(TCOG 1001)
Region
| Japan |
Condition
Condition
Chemo-Naive Patients with stage IIIB and IV Non-Squamous Non-Small-Cell Lung Cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and Safety of Carboplatin+Docetaxel+Bevacizumab in chemo-Naive Patients with stage IIIB and IV 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
Progression free survival
Key secondary outcomes
Objective Response Rate
Overall Survival
Safety
Biomarker,(predictive,prognostic)
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 |
Interventions/Control_1
CBDCA AUC=6(day1)+
Docetaxel 60mg/m2(day1)+
Bevacizumab 15mg/kg (day1)
q3weeks 4-6 cycles
followed by Bevacizumab 15mg/kg (day1) q3weeks until disease progression
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 IIIb or IV(UICC-7)or recurrent disease after surgery
3)chemo-naive patients
-Adjuvant and neo-adjuvant chemotherapy are considered as one regimen of chemotherapy.
-Treatment by UFT is not considered as one regimen of chemotherapy.
4)age:20-74years old
5)ECOG PS 0-1
6)Patients with measurable lesion (RECIST ver 1.1)
7)if the patient underwent therapy, there should be the following interval between the therapy and the registration.
-Radiotherapy other than thoracic radiation ->2week
-Surgery, ->4weeks
-Thoracic drainarge->2weeks
-Open biopsy, CV-port reservation, Treatment of injury->2 weeks
-Aspiration biopsy, ->1 week
-Postoperative Adjuvant Chemotherapy Using UFT, ->6months
8)sufficient organ function
neutro>=1500/mm3
Plt >=100000/mm3
Hb >=9.0g/dl
GOT/GPT <= ULNx2.5IU/L
T-bil <= ULNx1.5mg/dl
CCr. >= 45mL/min
SpO2 >= 93%
Proteinuria <=(1+) or 2g/24hr
9)Patients are expected to live over 3 months
10)Written IC
Key exclusion criteria
1)uncontrolled infection or serious medical complications
2)massive,pleural effusion or ascites (accept controllable pleural effusion with OK-432)
3)untreated current brain metastasis
4)severe cardiac disease
5)uncontrollable hypertension
6)receiving anticoagulant drug(except Aspirin under 325mg/day)
7)current or previous histoty ofhemoptysis(2.5ml)due to NSCLC
8)history of hemoptysis(over 1week)or receive oral/i.v. hemostatic drug
9)cavity in tumor
10with great vessel invasion
11)uncontrolled hypertension
12)current or previous(within the last 1 year)history of GI perforation
13)history of myocardial infarction and cerebral infarction
14)interstitial pneumonia or pulmonary fibrosis detectable on CT scan
15)history of drug induced interstitial pneumonia
16)The operation has been scheduled for the examination period
17)history of active double cancer within 5 years
18)history of active psychological disease
19)history of pregnancy or lactation
20)Patients whose participation in the trial is judged to be inappropriate by the attending doctor
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yuichi Takiguchi |
Organization
Graduate School of Medicine,Chiba University
Division name
Department of Chemotherapy
Zip code
Address
1-8-1, Inohana, Chuo-ku, Chiba, Japan
TEL
043-226-2805
takiguchi@faculty.chiba-u.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | TCOG1001 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
tcog1001@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
YES
Study ID_1
TCOG1001
Org. issuing International ID_1
The Tokyo cooperative oncology group
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 11 | Month | 09 | Day |
Related information
URL releasing protocol
http://link.springer.com/article/10.1007/s10147-014-0755-6
Publication of results
Published
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
Completed
Date of protocol fixation
| 2010 | Year | 09 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 11 | 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
| 2010 | Year | 11 | Month | 09 | Day |
Last modified on
| 2014 | Year | 12 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005011
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
