UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016904 |
|---|---|
| Receipt number | R000019620 |
| Scientific Title | A phase II study of erlotinib plus bevacizumab in chemo-naive patients aged 75 or older with advanced non-squamous non-small-cell lung cancer harboring sensitive EGFR gene mutations(HSR1501) |
| Date of disclosure of the study information | 2015/03/24 |
| Last modified on | 2020/08/25 10:24:09 |
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Basic information
Public title
A phase II study of erlotinib plus bevacizumab in chemo-naive patients aged 75 or older with advanced non-squamous non-small-cell lung cancer harboring sensitive EGFR gene mutations(HSR1501)
Acronym
A phase II study of AT for advanced Non-Sq NSCLC in elderly patients(HSR1501)
Scientific Title
A phase II study of erlotinib plus bevacizumab in chemo-naive patients aged 75 or older with advanced non-squamous non-small-cell lung cancer harboring sensitive EGFR gene mutations(HSR1501)
Scientific Title:Acronym
A phase II study of AT for advanced Non-Sq NSCLC in elderly patients(HSR1501)
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
The objective of this study is to evaluate the efficacy and safety of erlotinib plus bevacizumab in chemo-naive patients aged 75 or older with advanced non-squamous non-small-cell lung cancer harboring sensitive EGFR gene mutations.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Progression free survival
Key secondary outcomes
Response rate, overall survival, safety
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
Patients receive erlotinib plus bevacizumab every three weeks, as long as patients do not apply to treatment discontinuation criteria, until the disease progresses.
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
| 75 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
All participants must meet the following criteria
1: Pathologically proven Non-Sq NSCLC
2: Radiographically measurable lesion
3: Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
4: Stage 3B/4 NSCLC or recurrence disease without prior chemotherapy
5: Age more than 75 years
6: adequate organ function
Neutrophil count: more than 1,500/uL
Platelet count: more than 100,000/uL
Hemoglobin: more than 9.0 g/dL
Aspartate transaminase (AST), alanine transaminase(ALT): 2.5 times the upper limit of normal of the institutional reference range
Total bilirubin: less than 1.5mg/dL.
PaO2: more than 60 torr
Serum creatinine: less than 1.5mg/dL
7: Life expectancy of more than 12 weeks
8: Written informed consent
9:Sensitive EGFR mutation (exon19 deletion or exon21 L858R) confirmed by PCR
Key exclusion criteria
Exclusion criteria are as follows
1: Squamous cell carcinoma
2: Active interstitial pneumonia identified by chest X-ray
3: Current or previous histoty of hemoptysis (2.5ml) due to NSCLC
4: Uncontrolled massive pleural effusion or cardiac effusion
5: Superior vena cava syndrome
6: Uncontrolled brain metastases
7: Uncontrolled diabetes mellitus, hypertension, hepatic disorder, angina pectoris or previous myocardial infarction within the last 3 months
8: Severe infection
9: Pregnancy or lactation
10: Active concomitant malignancy
11: History of severe allergic reactions to drugs
12: Evidence of bleeding diathesis or hemoptysis
13: Current or previous history of cerebrovascular disease
14: Current or previous history of GI perforation
15: A history of chest irradaiation.
16: Exon T790M mutation detected by PCR
17: Severe and unstable medical comorbidities
18: Being unsuitable for receiving the study treatment, judged by attending physicians
Target sample size
26
Research contact person
Name of lead principal investigator
| 1st name | Takafumi |
| Middle name | |
| Last name | Suda |
Organization
Hamamatsu Univ. School of Medicine
Division name
Department of Internal medicine, second division
Zip code
4313192
Address
Handayama 1-20-1, Hamamatsu, Shizuoka pref. Japan
TEL
053-435-2263
suda@hama-med.ac.jp
Public contact
Name of contact person
| 1st name | Seiichiro |
| Middle name | |
| Last name | Suzuki |
Organization
Hamamatsu Univ. School of Medicine
Division name
Department of Internal medicine, second division
Zip code
4313192
Address
Handayama 1-20-1, Hamamatsu, Shizuoka pref. Japan
TEL
053-435-2111
Homepage URL
sesuzuki@hama-med.ac.jp
Sponsor or person
Institute
Department of Internal medicine, second division, Hamamatsu Univ. School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Internal medicine, second division, Hamamatsu Univ. School of Medicine
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
Hamamatsu Univ. School of Medicine
Address
1-20-1 Handayama, Hamamatsu
Tel
053-435-2111
rinri@hama-med.ac.jp
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
| 2015 | Year | 03 | Month | 24 | 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
| 2015 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2015 | Year | 02 | Month | 28 | Day |
Anticipated trial start date
| 2015 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 07 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 03 | Month | 24 | Day |
Last modified on
| 2020 | Year | 08 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019620
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