UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009602 |
|---|---|
| Receipt number | R000011260 |
| Scientific Title | A randomized Phase II Study of Bevacizumab in Combination with Docetaxel or S-1 as second line therapy in wild-type EGFR Patients with Non-Squamous Non-Small-Cell Lung Cancer. After failure to first line therapy, platinum doublet plus bevacizumab. |
| Date of disclosure of the study information | 2012/12/21 |
| Last modified on | 2021/07/06 14:00:15 |
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Basic information
Public title
A randomized Phase II Study of Bevacizumab in Combination with Docetaxel or S-1 as second line therapy in wild-type EGFR Patients with Non-Squamous Non-Small-Cell Lung Cancer. After failure to first line therapy, platinum doublet plus bevacizumab.
Acronym
A phase II study of A randomized phase II study of docetaxel plus bevacizumab vs S-1 plus bevacizumab as second line therapy for patients with NSCLC
Scientific Title
A randomized Phase II Study of Bevacizumab in Combination with Docetaxel or S-1 as second line therapy in wild-type EGFR Patients with Non-Squamous Non-Small-Cell Lung Cancer. After failure to first line therapy, platinum doublet plus bevacizumab.
Scientific Title:Acronym
A phase II study of A randomized phase II study of docetaxel plus bevacizumab vs S-1 plus bevacizumab as second line therapy for patients with NSCLC
Region
| Japan |
Condition
Condition
Non-Squamous Non-Small-Cell Lung Cancer
Classification by specialty
| Pneumology | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Efficacy and safety of Bevacizumab in Combination with Docetaxel or S-1 as second line therapy in wild-type EGFR Patients with Non-Squamous Non-Small-Cell Lung Cancer .After failure to first line therapy, platinum doublet plus bevacizumab.(A randomized Phase II Study)
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Progression free survival
Key secondary outcomes
Response rate
Disease control rate
Overall survival
Adverse events
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Historical
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Docetaxel(60mg/m2)day1 +Bevacizumab (15mg/kg) day 1
The treatment is repeated every three weeks until disease progression.
Interventions/Control_2
S-1 80mg-120mg/m2day1-day14
Bevacizumab 15mg/kg day1
The treatment is repeated every three weeks until disease progression.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) written informed consent
(2) It is judged by investigators to be treatable in this protocol
(3) age>=20years
(4) EGFR wild type mutation
* as for the variation that EGFR-TKI does not have the sensitivity, registration is possible(T790M ,exon20 insertion etc)
(5) histologically or cytologically proven non-squamous non-small cell lung cancer. after failure to first line therapy, platinum doublet plus bevacizumab
* maintenance therapy to follow platinum doublet is regard as a series of first line therapy
* EGFR-TKI(2nd-line erlotinib etc) is not regaed as the previous treatment
* include a recurrence post-operation.
in case of adjuvant chemotherapy, passing until first line therapy more than 6 months
* palliative radiation therapy (gamma-knife, irradiation to a bone metastatic ) to any place other than the original lesion genesis can register if there is it more than 2 weeks after the radiation therapy(registration is possible from day 15 as day0 on last treatment day)
(6) with measurable lesion(RECIST version 1.1)
(7) radical radiation therapy cannot adapt (case of clinical stage of a disease IIIB, IV or recurrence post-operation)
* using OK432 for hydrothorax control is possible
(8) ECOG PS 0-1
(9) adequate organ function
WBC >=4,000/mm3,<=12,000/mm3,
Platelet >=100,000/mm3 ,Hb >=9.0 g/dl ,ALT,AST <=2.0 x the Upper Limits of Normal (ULN)
(liver metastasis<=3.0 x ULN),T-bilirubin<=1.5 mg/dl , Serum creatinine 1.5 mg/dl ,CCr-60 ml/min,
ECG(within normal limit) ,SpO2>=94% , Urine protein<= 1+ or 2 g in urine collection for 24h
(10) life expectancy more than 3 months
Key exclusion criteria
(1) squamous metastasis
(2) activating EGFR sensitive mutation or unknown(sensitive EGFR mutation:G719X, exon19deletion,L858R,L861Q)
(3) having serious complications.
ex): a serious heart disease , cerebrovascular disorder, diabetes that it is hard to control or hypertention , a severe infection, pulmonary fibrosis, interstitial pneumonia, respiratory failure, bleeding, a large quantity of hydrothorax or abdominal dropsy retention, peptic ulcer of the activity, serious nerve disease
(4) symptomatic brain metastasis
(5) have an anamnesis and the complications , expectoration of fresh blood more than 2.5 ml due to non-small-cell lung cancer
(6) having an anamnesis of the following bloody phlegm or complications
* there is the dosage career when bloody phlegm occurring continuously (more than one week) or the anamnesis or the internal use styptic is continuous(the cases that an internal use styptic was necessary for again after having been relieved using an internal use styptic or the bloody phlegm which needs with a history of bloody phlegm, the dosage of the injection styptic to need the dosage or the dosage)
(7) current or previous (within the last 1 year) history of GI perforation
(8) the operation has been scheduled for the examination period
(9) have multiple primary cancer
(10) history of serious drug hypersensitivity
(11) pregnancy or lactation
(12) active psychological disease
(13) receives the steroid continuously(p.o. or i.v.)
(14) any other medical condition that makes the patient unsuitable for inclusion in the study according to the opinion of the investigator.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Koichi Takayama |
Organization
Kyushu University, Graduate School of Medical Sciences
Division name
Research Institute for Diseases of the Chest
Zip code
Address
3-1-1 Maidashi, higashi-ku, Fukuoka, Japan , 812-8582
TEL
092-642-5378
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Taishi Harada |
Organization
Kyushu University Hospital
Division name
respiratory division
Zip code
Address
3-1-1 Maidashi, higashi-ku, Fukuoka, Japan , 812-8582
TEL
092-642-5378
Homepage URL
Harada-t@kokyu.med.kyushu-u.ac.jp
Sponsor or person
Institute
Lung Oncology Group in Kyushu, Japan (LOGIK)
Institute
Department
Personal name
Funding Source
Organization
Clinical Research Support Center Kyushu
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
JAPAN
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
九州大学（福岡県）
国立病院機構九州医療センター（福岡県）
福岡赤十字病院（福岡県）
福岡大学（福岡県）
福岡大学筑紫病院（福岡県）
久留米大学（福岡県）
聖マリア病院（福岡県）
佐賀大学（佐賀県）
今給黎総合病院（鹿児島県）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 12 | Month | 21 | 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 | 11 | Month | 12 | Day |
Date of IRB
| 2013 | Year | 02 | Month | 08 | Day |
Anticipated trial start date
| 2012 | Year | 11 | Month | 30 | Day |
Last follow-up date
| 2016 | Year | 10 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 12 | Month | 21 | Day |
Last modified on
| 2021 | Year | 07 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011260
