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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000010804
Receipt No. R000012127
Scientific Title Phase II study of Pemetrexed and Cisplatin plus Bevacizumab with Maintenance Pemetrexed as First-Line Therapy for Nonsquamous Non-small-cell Lung Cancer (ALCT001)
Date of disclosure of the study information 2013/05/25
Last modified on 2015/06/07

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Basic information
Public title Phase II study of Pemetrexed and Cisplatin plus Bevacizumab with Maintenance Pemetrexed as First-Line Therapy for Nonsquamous Non-small-cell Lung Cancer (ALCT001)
Acronym Phase II study of PEM and CDDP plus Bev with Maintenance PEM as First-Line Therapy for Non-sq NSCLC (ALCT001)
Scientific Title Phase II study of Pemetrexed and Cisplatin plus Bevacizumab with Maintenance Pemetrexed as First-Line Therapy for Nonsquamous Non-small-cell Lung Cancer (ALCT001)
Scientific Title:Acronym Phase II study of PEM and CDDP plus Bev with Maintenance PEM as First-Line Therapy for Non-sq NSCLC (ALCT001)
Region
Japan

Condition
Condition Nonsquamous Non-small-cell Lung Cancer
Classification by specialty
Pneumology Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 This study evaluated the efficacy and safety of pemetrexed, cisplatin, and bevacizumab followed by maintenance pemetrexed in patients with chemotherapy-naive stage IIIB or stage IV non-squamous non-small-cell lung cancer.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes The primary end point of this study was PFS, defined as the time from registration to the time of documented disease progression.
Key secondary outcomes Safety,Response rate,Disease control rate,OS,1-year survival rate,QOL

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 Pemetrexed and Carboplatin plus Bevacizumab with maintenance pemetrexed as first-line therapy
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
75 years-old >
Gender Male and Female
Key inclusion criteria 1) histologically or cytologically
confirmed
2)newly diagnosed stage IIIB,IV
3)recurrent NSCLC for which they had not received chemotherapy
4)measurable or nonmeasurable disease as
defined by Response Evaluation Criteria in Solid Tumors
5)ECOG Performance status 0-1
6)age 20-74 years
7)Patients expected to survive longer than at least three months
8)adequate hematologic, hepatic, and renal functions
9)Patients who provide written informed consent
Key exclusion criteria 1)active or symptomatic interstitial lung disease
2)clinically significant cardiovascular disease and DVT
3)medically uncontrolled hypertension and diabetes
4)clinically significant infectious disease
5)history of diverticulitis or clinically significant diverticular disease
6)history of gross hemoptysis (2.5ml)
7)primary tumor in close proximity to a
major vessel
8)primary tumor with cavitation
9)melena
10)regular use of aspirin
11)proteinuria(Grade2)
12)history of thrombotic or hemorrhagic disorder
13)uncontrollable pleural effusion and ascites
14)symptomatic brain metastasis
15)active double cancer
16)pregnancy or lactation
Target sample size 25

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takuma Yokoyama
Organization Kyorin Univercity Hospital
Division name Department of Respiratory Medicine
Zip code
Address 6-20-2 shinkawa, Mitaka city,Tokyo
TEL 0422-47-5511
Email taku@ks.kyorin-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takuma Yokoyama
Organization Kyorin Univercity Hospital
Division name Department of Respiratory Medicine
Zip code
Address 6-20-2 shinkawa, Mitaka city,Tokyo
TEL 0422-47-5511
Homepage URL
Email taku@ks.kyorin-u.ac.jp

Sponsor
Institute Kyorin Univercity Hospital
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Other
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 杏林大学医学部付属病院(東京都)

Other administrative information
Date of disclosure of the study information
2013 Year 05 Month 25 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
2010 Year 11 Month 15 Day
Date of IRB
Anticipated trial start date
2010 Year 11 Month 23 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
2015 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date
2013 Year 05 Month 25 Day
Last modified on
2015 Year 06 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012127

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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