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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000012786
Receipt No. R000014925
Scientific Title Randomized phase II study of docetaxel + bevacizumab or pemetrexed + bevacizumab for elderly non-squamous non-small-cell lung cancer. (TORG1323)
Date of disclosure of the study information 2014/01/11
Last modified on 2019/04/24

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Basic information
Public title Randomized phase II study of docetaxel + bevacizumab or pemetrexed + bevacizumab
for elderly non-squamous non-small-cell lung cancer. (TORG1323)
Acronym Randomized phase II study of DOC + BEV or PM +BEV for elderly non-squamous NSCLC. (TORG1323)
Scientific Title Randomized phase II study of docetaxel + bevacizumab or pemetrexed + bevacizumab
for elderly non-squamous non-small-cell lung cancer. (TORG1323)
Scientific Title:Acronym Randomized phase II study of DOC + BEV or PM +BEV for elderly non-squamous NSCLC. (TORG1323)
Region
Japan

Condition
Condition Advanced non-squamous non-small cell lung cancer
Classification by specialty
Pneumology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy and safety of docetaxel+bevacizumab or pemetrexed+bevacizumab for previously untreated elderly 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 II

Assessment
Primary outcomes Progression-free survival (central review)
Key secondary outcomes Safety
Progression-free survival ( attending investigator's assessment)
Response rate(RR)
Overall survival(OS)
Time to treatment failure
QOL

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 docetaxel + bevacizumab
Interventions/Control_2 pemetrexed + bevacizumab
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
75 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1)Histologically or cytologically confirmed non-squamous, non-small cell lung cancer
2)Clinical stage IIIB(not amenable to curative radiation),VI or recurrent disease
3)ECOG performance status 0-1
4)Patients who have at least one or more measurable lesion by RESIST(Version1.1)
5)Aged 75<=
6)Adequate organ funcution
7)Interval
(1)Radiation therapy
More than 2 weeks after the last radiation therapy for nonthoracic region or brainmetastasis resion
(2)Operation
More than 4 weeks after the last operation
More than 2 weeks after the last pleurodesis or thoracic cavity drainage.
More than 8 weeks after the last operation with brain metastasis
8)Estimated life expectancy at least 12 weeks
9)Written informed consent

Key exclusion criteria 1)History of pulmonary hemorrhage/hemoptysis defined as bright red blood of at least 2.5mL within 12 weeks prior to registration
2)Symptomatic brain metastasis
3)Current or recent(within 10 days prior to first dose of bevacizumab) use of aspirin(>325mg/day), clopidogrel(>75mg/day), or current or recent(within 10 days prior to first dose of bevacizumab) use of anticlotting drug or thrombolytic agent
4)hypertension(blood pressure systolic>150mmHg and/ or diastolic >100mmHg) with or without treatment
5)Active double malignancies
6)Radiotherapy to lung field or mediastinum
7)Evidence of tumor invading a perihilar blood vessel on imaging
8)Evidence of tumor invading segmental bronchus or subsegmental bronchus on bronchofiberscopy
9)Having a history or serious complications
10)Receiving systemic treatment of steroid or immunosuppressant within 2 weeks prior to registration
11)Psychotic disorder
12)Uncontrolled ascites, pleural effusion or cardiac effushion
13)Double cancer less than 5 years disease free period
14)Severe drug allergy
15)ctive hepatic diseases
16)A past hypersensitive for polysorbate

Target sample size 120

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tetsu Shinkai
Organization Shonan east general hospital
Division name Cancer center
Zip code
Address 500, Nishikubo, Chigasaki, Kanagawa
TEL 0467-83-9111
Email teshinkai@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Naoyuki Nogami, Toshiyuki Kozuki
Organization National Hospital Organization Shikoku Cancer Center
Division name Department of thoracic oncology
Zip code
Address 160 Kou Minamiumemoto-machi, Matsuyama, Ehime 791-0280
TEL 089-999-1111
Homepage URL
Email nnogami@shikoku-cc.go.jp

Sponsor
Institute Thoracic Oncology Research Group
Institute
Department

Funding Source
Organization CHUGAI PHARMACUTICAL CO., LTD.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

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

Other administrative information
Date of disclosure of the study information
2014 Year 01 Month 11 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 Completed
Date of protocol fixation
2013 Year 12 Month 19 Day
Date of IRB
2014 Year 02 Month 17 Day
Anticipated trial start date
2014 Year 02 Month 03 Day
Last follow-up date
2017 Year 09 Month 30 Day
Date of closure to data entry
2017 Year 11 Month 30 Day
Date trial data considered complete
Date analysis concluded
2018 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2014 Year 01 Month 08 Day
Last modified on
2019 Year 04 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014925

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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