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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000016904 |
Receipt No. | 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 |
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 |
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Condition | ||
Condition | Advanced non-squamous non-small-cell lung cancer | |
Classification by specialty |
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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 |
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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 |
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Age-upper limit |
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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 |
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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 |
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Target sample size | 26 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
Institute | Department of Internal medicine, second division, Hamamatsu Univ. School of Medicine |
Institute | |
Department |
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 |
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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 |
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Anticipated trial start date |
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Last follow-up date |
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Date analysis concluded |
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Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019620 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |