UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006721 |
|---|---|
| Receipt number | R000007944 |
| Scientific Title | Phase II study of Pemetrexed plus Bevacizumab (YCRG04) in exacerbation cases of Non-squamous Non-small cell lung cancer, previously treated with bevacizumab plus platinum-based chemotherapy. |
| Date of disclosure of the study information | 2011/11/15 |
| Last modified on | 2017/01/30 12:51:24 |
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Basic information
Public title
Phase II study of Pemetrexed plus Bevacizumab (YCRG04) in exacerbation cases of Non-squamous Non-small cell lung cancer, previously treated with bevacizumab plus platinum-based chemotherapy.
Acronym
Phase II study of PEM plus Bevacizumab in patients with NSCLC previously treated with bevacizumab plus platinum-based chemotherapy (YCRG-04).
Scientific Title
Phase II study of Pemetrexed plus Bevacizumab (YCRG04) in exacerbation cases of Non-squamous Non-small cell lung cancer, previously treated with bevacizumab plus platinum-based chemotherapy.
Scientific Title:Acronym
Phase II study of PEM plus Bevacizumab in patients with NSCLC previously treated with bevacizumab plus platinum-based chemotherapy (YCRG-04).
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 assess the safety and efficacy of Bevacizumab plus Pemetrexed in exacerbation cases of Non-squamous Non-small cell lung cancer, previously treated with bevacizumab plus platinum-based chemotherapy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
response rate
Key secondary outcomes
disease control rate, progression- free survival, overall survival, Time from the initination of previous treatment to the progression of disease after the treatment with this protocol, frequency of adverse events.
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
To continue chemotherapy with Bevacizumab plus Pemetrexed until the onset of ecxacerbation or intolerable adverse event.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)>=20years-old
2)StageIIIB/IV unsuitable for radical irradiation or postoperative recurrent Non-Squamous NSCLC.
3)Documented disease progression after bevacizumab plus a platinum-based chemotherapy
4)Life expectancy>=3months
5)Eastern Cooperative Oncology Group(ECOG)Performance Status0,1
6)Measurable lesion meeting RECIST criteria(version1.1)
7)Adequate organ function neutrophil count:>=2,000/mm3or<=13,000/mm3
Platelet count:>=100,000/mm3
Hemoglobin:>=9.5g/dl
AST,ALT<=2.5*upper limit of normal
Total bilirubin:<=1.5mg/dl
creatinine:<=1.5mg/dl
PT-INR:<=1.5
Urinary protein negative or 1+
PaO2>=90%
8)Written informed consent
Key exclusion criteria
1)Prior Pemetrexed treatment
2)History of hemoptysis(>=2.5ml)
3)History of severe drug allergy
4)Thrombosis
5)Active infection
6)Any other serious complication
(severe heart disease, perforation of the digestive tract, uncontrollable diabetes or hypertension, gastrointestinal hemorrhage, paresis of intestine, illeus, interstinal lung disease etc.)
7)Prior radiotherapy to the chest or the more than 20% region of bone with hematopoietic capacity
8)Massive pleural or pericardial effusion, ascites
*include patients if there is no accumulation within two weeks after dranage tube was removed.
*exclude patients if pleurosclerosis was performed with anti-cancer drugs except OK-432
9)Inadequate interval after prior treatments
*operation including exploratory or diagnostic thoracotomy within 4 weeks
*palliative radiotherapy within 2 weeks
*biopsy with incision and treatment for trauma (exclude patiente with unhealed wound) within 2 weeks
*transfusion or use of hematopoietic factor within 2weeks.
10)Concomitant malignancy
11)Severe psychotic disorder
12)Pregnancy,Lactation,declined contraception
13)Inappropriate for this study judged by the attending physician
Target sample size
45
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takeshi Kaneko |
Organization
Yokohama City University Medical Center
Division name
Respiratory Disease Center
Zip code
Address
4-57 Urafune-cho, Minami-ku, Yokohama City, 232-0024, Japan
TEL
045-261-5656
takeshi@med.yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masaharu Shinkai |
Organization
Yokohama City University Medical Center
Division name
Respiratory Disease Center
Zip code
Address
4-57 Urafune-cho, Minami-ku, Yokohama City, 232-0024, Japan
TEL
045-261-5656
Homepage URL
shinkai@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University Medical Center
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
横浜市立大学附属市民総合医療センター（神奈川県）
大和市立病院（神奈川県）
神奈川県立がんセンター（神奈川県）
藤沢市民病院（神奈川県）
関東労災病院（神奈川県）
横浜南共済病院（神奈川県）
横浜市立大学附属病院（神奈川県）
国立病院機構横浜医療センター（神奈川県）
横浜船員保険病院（神奈川県）
茅ヶ崎市立病院（神奈川県）
横浜栄共済病院（神奈川県）
防衛医科大学校病院（埼玉県）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 11 | Month | 15 | 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
Terminated
Date of protocol fixation
| 2011 | Year | 08 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 11 | Month | 14 | Day |
Last modified on
| 2017 | Year | 01 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007944
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