UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003645 |
|---|---|
| Receipt number | R000004410 |
| Scientific Title | Phase II study of CDDP/Alimuta combined with bevacizumab in patients with advanced non-small-cell lung cancer without harboring sensitive EGFR mutations |
| Date of disclosure of the study information | 2011/01/01 |
| Last modified on | 2020/05/27 10:51:00 |
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Basic information
Public title
Phase II study of CDDP/Alimuta combined with bevacizumab in patients with advanced non-small-cell lung cancer without harboring sensitive EGFR mutations
Acronym
ALPS trial
Scientific Title
Phase II study of CDDP/Alimuta combined with bevacizumab in patients with advanced non-small-cell lung cancer without harboring sensitive EGFR mutations
Scientific Title:Acronym
ALPS trial
Region
| Japan |
Condition
Condition
advanced non-small-cell lung cancer without harboring sensitive EGFR mutations
Classification by specialty
| Medicine in general | Pneumology | Chest surgery |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
efficacy and safety
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase II
Assessment
Primary outcomes
progression free survival
Key secondary outcomes
response rate, safety, overall survival, one-year-survial
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
chemotherapy
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
Patients were eligible if they had histologically or cytologically proven unresectable locally advanced NSCLC (clinical stage 3 b with pleral effusion or stage 4, without a history of prior chemotherapy and radiotherapy. In addition, EGFR mutations were analyzed using the available tissue for diagnosis and patients without carrying EGFR mutations were enrolled in the study. Other criteria included the following: 1)age over20 and lessthan 75 years, 2) World Health Organization (WHO) performance status 0-2, 3) measurable disease and an estimated life expectancy over 3 months, 4) adequate bone marrow function (neutrophil count >2000/ul, hemoglobin 9 g/dl, platelets counts > 100,000/ul ), normal hepatic function (total bilirubin level < 1.5 times and AST < 2.5 times the upper normal limits), and renal function (creatinine <1.2 mg/dl, creatinine clearance > 45 ml/min), and partial oxygen tension over 60 torr.
Key exclusion criteria
1) pulmonary fibrosis on chest radiograph, 2)active infection, 3) severe heart disease, 4) past history of hypersensitivity to drugs, 5) pleural or pericardial effusion that required drainage, 6) brain metastasis or 7) pregnancy. Patients with a concomitant active malignancy were also excluded. Other concomitant anticancer therapy or experimental drug administration of any type was not permitted.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tomonobu Koizumi |
Organization
Shinshu University School of Medicine
Division name
First Department of Internal Medicine
Zip code
Address
3-1-1 Asahi Matsumoto
TEL
0263-37-2631
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomonobu Koizumi |
Organization
Shinshu University School of Medicine
Division name
First Department of Internal Medicine
Zip code
Address
3-1-1 Asahi Matsumoto
TEL
0263-37-2631
Homepage URL
Sponsor or person
Institute
Department of Comprehensive Cancer Therapy, Shinshu Universituy School of Medicine
Institute
Department
Personal name
Funding Source
Organization
public insurance
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
信州大学付属病院（長野県）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 01 | Month | 01 | 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
| 2009 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2009 | Year | 12 | Month | 08 | Day |
Anticipated trial start date
| 2010 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2013 | Year | 12 | Month | 01 | Day |
Date trial data considered complete
| 2013 | Year | 12 | Month | 01 | Day |
Date analysis concluded
| 2015 | Year | 12 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 05 | Month | 20 | Day |
Last modified on
| 2020 | Year | 05 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004410
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