UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004118 |
|---|---|
| Receipt number | R000004951 |
| Scientific Title | A phase I/II study of Bevacizumab combined with Cisplatin and Pemetrexed for Patients with Advanced Non-Squamous Non-Small-Cell Lung Cancer |
| Date of disclosure of the study information | 2010/08/27 |
| Last modified on | 2022/09/05 17:27:53 |
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Basic information
Public title
A phase I/II study of Bevacizumab combined with Cisplatin and Pemetrexed for Patients with Advanced Non-Squamous Non-Small-Cell Lung Cancer
Acronym
A phase I/II study of Bevacizumab combined with Cisplatin and Pemetrexed for Patients with Non-Small-Cell Lung Cancer
Scientific Title
A phase I/II study of Bevacizumab combined with Cisplatin and Pemetrexed for Patients with Advanced Non-Squamous Non-Small-Cell Lung Cancer
Scientific Title:Acronym
A phase I/II study of Bevacizumab combined with Cisplatin and Pemetrexed for Patients with Non-Small-Cell Lung Cancer
Region
| Japan |
Condition
Condition
non-squamous non-small-cell lung cancer
Classification by specialty
| Pneumology | Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of bevacizumab combined with Cisplatin and Pemetrexed for patients with advanced non-squamous non-small cell lung cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I,II
Assessment
Primary outcomes
STEP1
Safety
STEP2
Overall Response Rate
Key secondary outcomes
Progression-free survival (PFS)
Overall Survival
Overall Response Rate for combination CT
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
Cislpatin (75mg/m2 day1) + Pemetrexed(500mg/m2 day1) + Bevacizumb (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-sqamous non-small-cell lung cancer
2) Stage III/IV without indication for curative resection and post-operative recurrent disease
3) Patients aged 20-74 years
4) ECOG performance status 0-1
5) Target lesion is measurable(RECISTver1.1)
6) Chemotherapy naive
7) Excepted to live over 3 months after administration day
8) More than 2 months rest period after radiation
9) Adequate organ function
10) Written informed consent from the patients
Key exclusion criteria
1) squamous cell carcinoma
2) Patients unable to take or unsupplied with folic acid and vitamin B12
3) History of grave drug allergic react
4) current or previous histoty of hemoptysis (2.5ml) due to NSCLC
5) Interstitial pneumonia or pulmonary fibrosis detectable on Chest X-ray
6) Brain metastases with neurological symptoms
7) Pleural effusion, pericardial effusion and ascites to need treatment
8) Severe renal function disorder, 2+ or higher proteinuria within 2 weeks prior to enrollment
9) Uncontrollable diabetes mellitus and hypertenson
10) severe cardiac disease
11) Current or previous history of cerebrovascular disease
12) Current of amalgamated venous thromboembolism
13) Uncontrollable infectious disease
14) current or previous (within the last 1 year) history of GI perforation
15) Traumatic fracture of unrecovery
16) active concomitant malignancy
17) Thoracic radiotherapy has been scheduled for the examination period
18) Surgical procedure within 28 days before registration
19) history of pregnancy or lactation
20) No intention to practice birth control
21) Patients whose participation in the trial is judged to be inappropriate by the attendeing doctor
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | kazuhito |
| Middle name | |
| Last name | Funai |
Organization
Hamamatsu University School of Medicine
Division name
First Department of Surgery
Zip code
4313192
Address
1-20-1, Handayama, higashi-ku, Hamamatsu, Shizuoka. Japan
TEL
053-435-2276
kfunai@hama-med.ac.jp
Public contact
Name of contact person
| 1st name | kazuhito |
| Middle name | |
| Last name | Funai |
Organization
Hamamatsu University School of Medicine
Division name
First Department of Surgery
Zip code
43131927
Address
1-20-1, Handayama, higashi-ku, Hamamatsu, Shizuoka. Japan
TEL
053-435-2276
Homepage URL
kfunai@hama-med.ac.jp
Sponsor or person
Institute
Hamamatsu University School of Medicine, First Department of Surgery
Institute
Department
Personal name
Funding Source
Organization
Hamamatsu University School of Medicine, First Department of Surgery
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
Hamamatsu University School of Medicine
Address
1-20-1 Handayama, Higashi-ku, Hamamatsu, Japan
Tel
053-435-2680
rinri@hama-med.ac.jp
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
浜松医科大学（静岡県）、県西部浜松医療センター（静岡県）
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 08 | Month | 27 | 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
82
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 | 07 | Month | 12 | Day |
Date of IRB
| 2014 | Year | 09 | Month | 03 | Day |
Anticipated trial start date
| 2014 | Year | 09 | Month | 03 | Day |
Last follow-up date
| 2021 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 08 | Month | 27 | Day |
Last modified on
| 2022 | Year | 09 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004951
