UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003566 |
|---|---|
| Receipt number | R000004263 |
| Scientific Title | Bevacizumab (Avastin) therapy in combination with carboplatin and weekly paclitaxel for advanced non-squamous non-small cell lung cancer |
| Date of disclosure of the study information | 2010/05/05 |
| Last modified on | 2017/05/10 10:05:30 |
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Basic information
Public title
Bevacizumab (Avastin) therapy in combination with carboplatin and weekly paclitaxel for advanced non-squamous non-small cell lung cancer
Acronym
Bevacizumab (Avastin) therapy in combination with carboplatin and weekly paclitaxel for advanced non-squamous non-small cell lung cancer
Scientific Title
Bevacizumab (Avastin) therapy in combination with carboplatin and weekly paclitaxel for advanced non-squamous non-small cell lung cancer
Scientific Title:Acronym
Bevacizumab (Avastin) therapy in combination with carboplatin and weekly paclitaxel for advanced non-squamous non-small cell lung cancer
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
Investigation of efficacy and safety of bevacizumab in combination with carboplatin and weekly paclitaxel for patients with advanced non-squamous non-small cell lung cancer who are not treated 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
Safety, Progression free survival, Time to response, Response duration, Overall survival
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
Patients receive paclitaxel on days 1, 8, and 15 and carboplatin [area under the curve (AUC) = 6] on day 1 and Bevacizumab(15mg/kg,i.v.) on day1, every four weeks, up to six cycles. Patients who still control disease without unacceptable toxicity, then continuously treated with Bevacizumab(15mg/kg,i.v.) on Day1, every three weeks, 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
| 74 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Written informed consent
(2) Age: 20-74 years old
(3)ECOG performance status of 0 or 1
(4) Life expectancy more than 3 months (5)histologically or cytologically confirmed non-squamous non-small cell lung cancer(NSCLC)
(6)StageIV or postoperative recurrence non-squamous non-small cell lung cancer
(7)cheno-naive patient
(8)Measurable by RECST(ver 1.1) criteria.
(9) If the patient underwent therapy, there should be the following interval between the therapy and the registration
1)immunotherapy and endcrintherapy ->3 weeks
2)Radiotherapy other than thoracic radiation ->2 week
3)Surgery ->4 weeks
4)Thoracic drainarge ->2 weeks
5)Open biopsy, treatment of injury ->2 weeks
6) Transfusion and growth factor ->2 weeks
7)Aspiration biopsy, CV-port reservation ->1 week
(10) Adequate organ function
Key exclusion criteria
(1) brain metastasis
(2) active concomitant malignancy
(3) Current or previous history of hemoptysis or active hemosputum
(4) evidence of bleeding diathesis or coagulopathy
(5) Current or previous history of Pericardial effusion
(6) superior vena cava syndrome
(7) spinal cord compression
(8) Current or previous (within the last 1 year) history of cerebrovascular disease
(9) Traumatic fracture of unrecovery
(10) History of active infection
(11) The operation has been scheduled for the examination period
(12) receiving anticoagulant drug(except Aspirin under 324mg/day)
(13) Uncontrollable Gastrointestinal ulceration
(14) Current or previous (within the last 1 year) history of GI perforation
(15) Uncontrollable hypertension
(16) severe cardiac disease
(17)Interstitial pneumonia or pulmonary fibrosis detectable on CT scan or X-ray
(18)peripheral neuropathy > Grade2
(19) severe drug allergy
(20) history of hypersensitivity of Taxans or alcohol and the medicine made of the polio castor oil content
(21) treatment history of bevacizumab
(22) History of pregnancy or lactation
(23) No intention to practice birth control
(24) those judged to be not suitable by the attending physician
Target sample size
33
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masahiro Yamasaki |
Organization
Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital
Division name
Department of Respiratory Medicine
Zip code
Address
1-9-6 Senda-machi Nakaku hirosihima-city 730-8619 Japan
TEL
082-241-3111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Soumuka |
Organization
Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital
Division name
Department of Respiratory Medicine
Zip code
Address
1-9-6 Senda-machi Nakaku Hiroshima-city 730-8619 Japan
TEL
082-241-3111
Homepage URL
soumu@hiroshima-med.jrc.or.jp
Sponsor or person
Institute
Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital
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
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 05 | Month | 05 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://ar.iiarjournals.org/content/37/2/923.full
Number of participants that the trial has enrolled
Results
The overall response rate was 76%.
The median progression free survival and overall survival were 8.4 months and 22.2 months, respectively.
Grade 3-4 toxicities included neutropenia in 55% of patients, anemia in 18%, febrile neutropenia in 12%, and anorexia in 9%. No treatment-related deaths were observed.
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
Main results already published
Date of protocol fixation
| 2010 | Year | 05 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 06 | Month | 02 | Day |
Last follow-up date
| 2015 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2015 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2015 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2016 | Year | 06 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 05 | Month | 05 | Day |
Last modified on
| 2017 | Year | 05 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004263
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
