UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009571 |
|---|---|
| Receipt number | R000011232 |
| Scientific Title | An exploratory observational study of standard chemotherapy with or without Bevacizumab for advanced or recurrent non-squamous non-small-cell lung cancer |
| Date of disclosure of the study information | 2012/12/18 |
| Last modified on | 2012/12/18 13:06:09 |
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Basic information
Public title
An exploratory observational study of standard chemotherapy with or without Bevacizumab for advanced or recurrent non-squamous non-small-cell lung cancer
Acronym
An exploratory observational study of standard chemotherapy with or without Bevacizumab for advanced or recurrent non-squamous non-small-cell lung cancer
Scientific Title
An exploratory observational study of standard chemotherapy with or without Bevacizumab for advanced or recurrent non-squamous non-small-cell lung cancer
Scientific Title:Acronym
An exploratory observational study of standard chemotherapy with or without Bevacizumab for advanced or recurrent non-squamous non-small-cell lung cancer
Region
| Japan |
Condition
Condition
non-squamous non-small-cell lung cancer
Classification by specialty
| Medicine in general | Pneumology | Surgery in general |
| Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To examine the efficacy and safety of standard chemotherapy with or without Bevacizumab for advanced or recurrent non-squamous non-small-cell lung cancer in clinical practice.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase IV
Assessment
Primary outcomes
Efficacy and safety(Response rate)
Key secondary outcomes
Progression free survival, overall survival, adverse event, Predictive factors(characteristic, EGFR genetic mutation, hypertension)
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Treatable or treated with standard chemotherapy with or withou Bevacizumab
2.Observable from the initial treatment for NSCLC.
3.Confirmed as Stage3B(unsuitable for definitive radiotherapy),Stage4,or recurrent non-squamous NSCLC.
4.Eastern Cooperative Oncology Group performance status of 0-2
5. Written informed consent can be obtained.
Key exclusion criteria
1.Uncontrolled ascites, pleural effusion,or pericardial effusion,
2.Patients with infectious disease requiring systemic administration of antiviral agents,antifungal agents,or antibiotics.
3.Patients with multiple cancers within 5years prior to initiation of the study, except for carcinoma in situ, mucosal cancer appropriately treated non-melanoma, cervical cancer, thyroid cancer, early gastric cancer, early colorectal cancer.
4.Patients with serious complications (such as heart disease,activity infection, interstitial pneumonia, diabetes)
5.Pregnant woman or those with suspected pregnancy,nursing woman and those who plan to become pregnant during the study period.
6.Other patients whom the investigation considers to be unsuitable for participation in the study.
In case of using Bevacizumab,confirm that the patients do not come under the following, as general.However, patients are allowed to be registered to this study as for as the doctor's decision.
1.Patients with symptomatic brain metastases.
2.Patients with history or complication of hemoptysis.
Definition of hemoptysis is determined by the following.
A history of continuous hemoptysis over one week, or hemoptysis receiving oral or intravenous hemostatic medicine.
3. Patients with tumor invasion to chest great vessels.
4. Patients with obvious tumor invasion to the lobar bronchi, main bronchus or trachea.
5. Patients with obvious lung lesion hollowing(>1cm).
6. Patients come under the following on the first day of administration
within a week from the last palliative radiotherapy.
within 8weeks from lobectomy surgery.
within 4weeks from exploratory thoracotomy.
within a week from thoracic drainage.
7.Patients with uncontrolled hypertension
8.Patients receiving anticoagulant therapy
Patients receiving 325mg aspirin therapy are allowed to be registered.
9.Patients with a history ofgastrointestinal perforation within an year,or a complication of uncontrollable peptic ulcer.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuya Horiuchi |
Organization
Showa University Northern Yokohama Hospital
Division name
Respiratory Center
Zip code
Address
Chigasaki-chuo 35-1 Tsuzuki-ku, Yokohama 224-503, Japan.
TEL
045-949-7000
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuya Horiuchi |
Organization
Showa University Northern Yokohama Hospital
Division name
Respiratory Center
Zip code
Address
Chigasaki-chuo 35-1 Tsuzuki-ku, Yokohama 224-503, Japan.
TEL
045-949-7000
Homepage URL
Sponsor or person
Institute
Respiratory Center, Showa University Northern Yokohama Hospital
Institute
Department
Personal name
Funding Source
Organization
Respiratory Center, Showa University Northern Yokohama Hospital
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
昭和大学横浜市北部病院（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 12 | Month | 18 | 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
Preinitiation
Date of protocol fixation
| 2011 | Year | 11 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 01 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Efficacy and safety(Response rate)
Management information
Registered date
| 2012 | Year | 12 | Month | 18 | Day |
Last modified on
| 2012 | Year | 12 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011232
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