UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003533 |
|---|---|
| Receipt number | R000004289 |
| Scientific Title | A randomized Phase II Study of Bevacizumab in Combination with Docetaxel or S-1 in Patients with Non-Squamous Non-Small-Cell Lung Cancer Previously Treated with Platinum based Chemotherapy |
| Date of disclosure of the study information | 2010/04/26 |
| Last modified on | 2017/05/01 09:11:11 |
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Basic information
Public title
A randomized Phase II Study of Bevacizumab in Combination with Docetaxel or S-1 in Patients with Non-Squamous Non-Small-Cell Lung Cancer
Previously Treated with Platinum based Chemotherapy
Acronym
A randomized Phase II Study of Bevacizumab in Combination with Docetaxel or S-1 in Patients with Non-Squamous Non-Small-Cell Lung Cancer
Previously Treated with Platinum based Chemotherapy
Scientific Title
A randomized Phase II Study of Bevacizumab in Combination with Docetaxel or S-1 in Patients with Non-Squamous Non-Small-Cell Lung Cancer
Previously Treated with Platinum based Chemotherapy
Scientific Title:Acronym
A randomized Phase II Study of Bevacizumab in Combination with Docetaxel or S-1 in Patients with Non-Squamous Non-Small-Cell Lung Cancer
Previously Treated with Platinum based Chemotherapy
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 in combination with docetaxel or S-1 for patients previously treated with 1 regimen platinum-doublet.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Progression free survival
Key secondary outcomes
Response rate
Overall survival
Disease control rate
Rate of adverse events
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Docetaxel(60mg/m2)day 1 +Bevacizumab (15mg/kg) day 1
The treatment is repeated every three weeks until disease progression or severe toxicity.
Interventions/Control_2
S-1: 40 mg/m2 twice daily(orally, day1 after dinner ; day15 after breakfast)+
Bevacizumab: 15mg/kg day 1
The treatment is repeated every three weeks until disease progression or severe toxicity.
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)Histologically or cytologically proven non-squamous non-small cell lung cancer
2)Non-squamous non-small cell lung cancer with stage IIIB,stage IV (UICC-7) or recurrent disease after surgery,who have previously treated platinum doublet.
3)With measurable lesion(RECIST version 1.1)
4)at an interval of more than four weeks from previous treatment
5)If the patient underwent therapy, there should be the following interval between the therapy and the registration
i)Radiotherapy other than thoracic radiation ->1 week
ii)Palliative radiotherapy including pulmonary field ->3 months
iii)Surgery(except CV-port reservation) ->4 weeks
iv)Thoracic drainarge ->2 weeks
v)Open biopsy, treatment of injury ->2 weeks
vi)Aspiration biopsy, CV-port reservation ->1 week
6)Age-> 20
7)ECOG PS 0-1
8)Adequate organ function
9)Life expectancy more than 3 months
10)Written informed consent
Key exclusion criteria
1)interstitial pneumonia or pulmonary fibrosis detectable on CT scan
2)history of drug induced interstitial pneumonia
3)history of severe drug allergy
4)patients previously treated with S-1 and docetaxel.
5)history of active infection or other serious disease condition
6)history of poorly controlled pleural effusion,pericardial effusion and ascites
7)history of severe heart disease(uncontrollable arrythmia,uncontrollable angina pectoris,heart failure, etc.)
8)uncontrollable hypertension
9)uncontrollable diabetes mellitus
10)curative radiotherapy pretreated to the chest.
11)current history of hemosputum
12)current or previous history hemoptysis
13)current or previous (within the last 1 year) history of cerebrovascular disease
14)current or previous (within the last 1 year) history of GI perforation
15)symptomatic brain metastasis
16)traumatic fracture of unrecovery
17)the operation has been scheduled for the examination period
18)tumor invasive to the chest large blood vessel. Cavity in brain or lung tumor
19)evidence of bleeding diathesis or coagulopathy
20)thrombosis that need to treat
21)severe drug allergy for 80 polysorbate content medicine
22)patients using Flucytosine
23)patients with contraindication of medication (DTX,S-1).
24)history of active double cancer
25)history of active psychological disease
26)history of pregnancy or lactation
27)any other medical condition that makes the patient unsuitable for inclusion in the study according to the opinion of the investigator.
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Fumio Imamura |
Organization
Osaka Medical Center for Cancer and Cardiovascular Diseases
Division name
Department of Pulmonary Oncology
Zip code
Address
1-3-3 Nakamichi, Higashinari-ku, Osaka 537-8511, Japan
TEL
06-6972-1181
imamura-fu@mc.pref.osaka.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazumi Nishino |
Organization
Osaka Medical Center for Cancer and Cardiovascular Diseases
Division name
Department of Pulmonary Oncology
Zip code
Address
1-3-3 Nakamichi, Higashinari-ku, Osaka 537-8511, Japan
TEL
06-6972-1181
Homepage URL
nisino-ka@mc.pref.osaka.jp
Sponsor or person
Institute
Hanshin Cancer Study Group
Institute
Department
Personal name
Funding Source
Organization
None
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
大阪府立成人病センター（大阪府）
神戸大学医学部附属病院（兵庫県）
神戸市立医療センター中央市民病院（兵庫県）
京都桂病院（京都府）
国立病院機構刀根山病院(大阪府）
先端医療センター（兵庫県）
兵庫県立がんセンター（兵庫県）
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 04 | Month | 26 | Day |
Related information
URL releasing protocol
http://www.sciencedirect.com/science/article/pii/S0169500215002834
Publication of results
Published
Result
URL related to results and publications
http://www.sciencedirect.com/science/article/pii/S0169500215002834
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 | 03 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 06 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
| 2014 | Year | 05 | Month | 31 | Day |
Date analysis concluded
| 2015 | Year | 02 | Month | 26 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 04 | Month | 26 | Day |
Last modified on
| 2017 | Year | 05 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004289
