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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003698
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Hyogo Cancer Center,Depatrment of Thoracic Oncology
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004478

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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