UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010804 |
|---|---|
| Receipt number | 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 01:13:05 |
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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
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
taku@ks.kyorin-u.ac.jp
Sponsor or person
Institute
Kyorin Univercity Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012127
