UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009476 |
|---|---|
| Receipt number | R000011130 |
| Scientific Title | A phase II study to evaluate efficacy and safety of Bevacizumab combined with Cisplatin and S-1 for Advanced Non-Squamous Non-Small-Cell Lung Cancer |
| Date of disclosure of the study information | 2013/02/01 |
| Last modified on | 2019/04/20 14:20:27 |
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Basic information
Public title
A phase II study to evaluate efficacy and safety of Bevacizumab combined with Cisplatin and S-1 for Advanced Non-Squamous Non-Small-Cell Lung Cancer
Acronym
A phase II study of Bevacizumab combined with Cisplatin and S-1 for Advanced Non-Squamous Non-Small-Cell Lung Cancer
(TCOG LC-1202)
Scientific Title
A phase II study to evaluate efficacy and safety of Bevacizumab combined with Cisplatin and S-1 for Advanced Non-Squamous Non-Small-Cell Lung Cancer
Scientific Title:Acronym
A phase II study of Bevacizumab combined with Cisplatin and S-1 for Advanced Non-Squamous Non-Small-Cell Lung Cancer
(TCOG LC-1202)
Region
| Japan |
Condition
Condition
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 bevacizumab combined with Cisplatin and S-1 advanced 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
Response Rate
Overall Survival
Waterfall Plot Analysis
Safety Profile
Quality of Life
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
Bevacizumb (15mg/kg day1) + Cislpatin (65mg/m2 day1) + S-1(80mg/m2 day1-14)
q3weeks at a target 6cycles(at least 4cycles) followed by Bevacizumab (15mg/kg day1) + S-1(80mg/m2 alternate-day(Mon.Wed.Fri.Sun.))
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
| 74 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Written IC
2.Patients aged 20-74 years
3.ECOG performance status 0-1
4.Excepted to live over 3 months after administration day
5.Histologically or cytologically confirmed non-squamous non-small-cell lung cancer
6.Stage III/IV or post-operative recurrent disease
7.No prior chemotherapy
8.Target lesion is measurable(RECISTver1.1)
9.Adequate organ function
Key exclusion criteria
1.Symptomatic brain metastases
2.history of active double cancer within 5 years
3.Current history of hemosputum or hemoptysis
4.Have possibly complication related to bleeding episode
5.Receiving anticoagulant drug (including Aspirin over 325mg/day)
6.Great vessel involvement
7.Have received radiation therapy to lesions of lung
8.Pleural effusion,peritoneal fluid, and pericardial fluid
9.Serious complications
10.Perforation of the digestive tract or history of the perforation of the digestive tract within the past one year
11.Uncontrollable Hypertension
12.Interstitial pneumonia or pulmonary fibrosis detectable on X ray
13.Proven or suspected infections diseases
14.Watery diarrhea or Chronic constipation
15.Under treatment by flucytosine
16.Hypersensitivity of Protocol agents
17.History of pregnancy or lactation and no intention to practice birth control
18.Patients whose participation in the trial is judged to be inappropriate by the attending doctor
Target sample size
39
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kaoru Kubota |
Organization
Nippon Medical School Hospital
Division name
nternal Medicine, Division of Pulmonary Medicine, Division of Medical Oncology
Zip code
Address
1-1-5, Sendagi, Bunkyo-ku, Tokyo, Japan
TEL
03-3822-2131
tcog-lc@tcog.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | TCOG LC 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
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 02 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
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
| 2012 | Year | 12 | Month | 12 | Day |
Date of IRB
| 2012 | Year | 12 | Month | 12 | Day |
Anticipated trial start date
| 2013 | Year | 01 | Month | 07 | Day |
Last follow-up date
| 2017 | Year | 12 | Month | 31 | 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
| 2012 | Year | 12 | Month | 04 | 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=R000011130
