UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003698 |
|---|---|
| Receipt number | R000004478 |
| Scientific Title | Phase II Study of Bevacizumab in Combination with Carboplatin plus oral S1 in Chemo-Naive Patients with Non-Squamous Non-Small-Cell Lung Cancer |
| Date of disclosure of the study information | 2010/06/02 |
| Last modified on | 2013/06/02 12:52:24 |
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Basic information
Public title
Phase II Study of Bevacizumab in Combination with Carboplatin plus oral S1 in Chemo-Naive Patients with Non-Squamous Non-Small-Cell Lung Cancer
Acronym
Phase II Stydy of Bevacizumab Combination with Carboplatin plus oral S1 in Lung Cancer. (HCC1002)
Scientific Title
Phase II Study of Bevacizumab in Combination with Carboplatin plus oral S1 in Chemo-Naive Patients with Non-Squamous Non-Small-Cell Lung Cancer
Scientific Title:Acronym
Phase II Stydy of Bevacizumab Combination with Carboplatin plus oral S1 in Lung Cancer. (HCC1002)
Region
| Japan |
Condition
Condition
Chemo-Naive Patients with 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
To evaluate the efficacy and safety of Bevacizumab in combination with Carboplatin plus oral S-1 in chemo-naive patients with non-squamous non-small-cell lung cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Response rate
Key secondary outcomes
Overall survival, Progression free survival , Disease control rate, Toxicity
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
Carboplatin AUC=5(day1)+S-1 80mg/m2 (day1~14)+Bevacizumab 15mg/kg (day1) q3weeks 3-6 cycles followed by Bevacizumab 15mg/kg (day1)+S-1 80mg/m2(day1~14) 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
| 74 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Patients with lung cancer which was pathologically proven non-squamous non-small cell lung cancer.
2)Patients with stage IIIb or IV(UICC-7) or recurrent disease after surgery who heve previously treated no chemotherapy.
-Adjuvant and neo-adjuvant chemotherapy are considered as one regimen of chemotherapy.
-Treatment by UFT is not considered as one regimen of chemotherapy.
3)Patiants who can take in drug orally
4)Patients with measurable lesion (RECIST ver 1.1)
5)If the patient underwent therapy, there should be the following interval between the therapy and the registration.
-Radiotherapy other than thoracic radiation ->1week
-Radiotherapy including pulmonary field->3months
-Surgery,except CV-port reservation->4weeks
-Thoracic drainarge->2weeks
-Open biopsy, treatment of injury->2 weeks
-Aspiration biopsy, CV-port reservation ->1 week
6) Age eligible for study-20-74 years old
7) ECOG PS 0-1
8)Sufficient organ function
neutro>=2000/mm3
Plt >=100000/mm3
Hb >=9.0g/dl
GOT/GPT <= ULNx2.5IU/L
T-bil <= ULNx1.5mg/dl
Cr. <= 1.5mg/dL
Proteinuria <=(1+) or 2g/24hr
SpO2 >= 92% or PaO2 >=60%
9)Patients are expected to live over 3 months
10)Written informed consent
Key exclusion criteria
1)Pulmonary fibrosis detected by chest CT
2)History of drug induced interstitial pneumonia
3)History of severe drug allergy
4)History of active infection or other serious complication
5)History of poorly controlled pleural effusion, pericardial effusion, and ascites
6)Treated by flucytosine(5-FC)
7)History of continuous (watery) diarrhea
8)History of ileus
9)History of severe heart disease(uncontrollable arrhythmia, uncontrollable angina pectoris, heart failure, etc)
10)Uncontrollable hypertension
11)Uncontrollable diabetes mellitus
12)Current or previous history of hemoptysis or hemosputum
13)Current or previous (within the last 1 year) history of symptomatic cerebrovascular disease
14)Current or previous (within the last 1 year) history of GI perforation
15)Symptomatic brain metastasis
16)Traumatic fracture of unrecovery
17)The operation has been scheduled during the examination period
18)Tumor invasive to the chest Laege bleed vessel.Cavity inbrain or lung tumor
19)Evidence of bleeding diathesis or coagulopathy
20)Thorombosis that need to treat
21)History of active double cancer with in 5 years
22)History of active psychological disease
23)History of pregnancy or lactation
24)Patients whose participation in the trial is judged to be inappropriate by the attending doctor
Target sample size
45
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Miyako Satouchi |
Organization
Hyogo Cancer Center
Division name
Thoracic Oncology
Zip code
Address
13-70 Kitaoji -cho, Akasi-city, Hyogo.
TEL
078-929-1151
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshiko Urata |
Organization
Hyogo Cancer Center
Division name
Thoracic Oncology
Zip code
Address
13-70 Kitaoji-cho, Akasi-city, Hyogo.
TEL
Homepage URL
Sponsor or person
Institute
Hyogo Cancer Center,Depatrment of Thoracic Oncology
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
近畿大学付属病院（大阪府）
兵庫県立がんセンター（兵庫県）
岸和田市民病院（大阪府）
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 06 | Month | 02 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://www.ncbi.nlm.nih.gov/pubmed/23558513
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
| 2010 | Year | 03 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 05 | 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
Management information
Registered date
| 2010 | Year | 06 | Month | 02 | Day |
Last modified on
| 2013 | Year | 06 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004478
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| Registered date | File name |
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| Registered date | File name |
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