UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000014314
Receipt No. R000016615
Scientific Title A phase II study of maintenance bevacizumab plus docetaxel following induction chemotherapy with cisplatin, pemetrexed plus bevacizumab for advanced non-squamous non-small-cell lung cancer
Date of disclosure of the study information 2014/06/19
Last modified on 2020/08/25 (Ver. 12)

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Basic information
Public title A phase II study of maintenance bevacizumab plus docetaxel following induction chemotherapy with cisplatin, pemetrexed plus bevacizumab for advanced non-squamous non-small-cell lung cancer
Acronym A phase II study of maintenance bevacizumab plus docetaxel for Non-Sq NSCLC(HSR1401)
Scientific Title A phase II study of maintenance bevacizumab plus docetaxel following induction chemotherapy with cisplatin, pemetrexed plus bevacizumab for advanced non-squamous non-small-cell lung cancer
Scientific Title:Acronym A phase II study of maintenance bevacizumab plus docetaxel for Non-Sq NSCLC(HSR1401)
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 bevacizumab plus docetaxel as maintenance therapy in patients who did not have progressive disease after receiving treatment with cisplatin, pemetrexed plus bevacizumab in advanced non-squamous non-small-cell lung cancer
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Progression free survival
Key secondary outcomes Response rate, disease control rate, overall survival, safety, QOL score(EQ-5D)

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 were included in the run-in phase (four cycles of cisplatin, pemetrexed plus bevacizumab).After induction chemotherapy, patients who did not have progressive disease receive bevacizumab plus docetaxel
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 All participants must meet the following criterias
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 adjuvant chemotherapy
5: Age more than 20 years and less 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
Creatinine: less than 1.2mg/dL
7: Life expectancy of more than 12 weeks
8: Written informed consent
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: With great vessel invasion
16: Exposure of the tumor to the central airway
17: Patients with therapeutic anticoagulopathy (including Aspirin over 325mg/day or Clopidogrel over 75mg/day)
18: Patients with arterial thrombosis or venous thrombosis
19: Severe and unstable medical comorbidities
20: Judgment to attending physician
Target sample size 45

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
Email may15@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 053-435-2263
Homepage URL
Email seszuki@hama-med.ac.jp

Sponsor
Institute Hamamatsu Univ. School of Medicine
Institute
Department

Funding Source
Organization none
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
Email 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
2014 Year 06 Month 19 Day

Related information
URL releasing protocol https://link.springer.com/article/10.1007/s12032-018-1172-x#citeas
Publication of results Published

Result
URL related to results and publications https://link.springer.com/article/10.1007/s12032-018-1172-x#citeas
Number of participants that the trial has enrolled 49
Results 
The median progression-free
survival from enrollment was 7.8 month
Results date posted
2020 Year 08 Month 25 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics 
Chemotherapy-naive
non-squamous NSCLC patients
Participant flow 
Patients who achieved disease control after induction therapy then received maintenance
therapy with docetaxel (50 mg/m2) and bevacizumab (15 mg/kg) until disease progression or unacceptable toxicity.
Adverse events 
The most common toxicities of grade
3 or higher were neutropenia (68.4%), leukopenia (50.0%), febrile neutropenia (31.8%), and hypertension.
Outcome measures 
The primary endpoint was progression-free survival from enrollment.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2014 Year 05 Month 14 Day
Date of IRB
2014 Year 05 Month 14 Day
Anticipated trial start date
2014 Year 06 Month 19 Day
Last follow-up date
2016 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
2014 Year 06 Month 19 Day
Last modified on
2020 Year 08 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016615