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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004715
Receipt No. R000005610
Scientific Title A randomized phase 2 study of Docetaxel with or without Bevacizumab after platinum-based chemotherapy plus bevacizumab in patients with advanced non-squamous non-small-cell lung cancer
Date of disclosure of the study information 2010/12/13
Last modified on 2016/03/11

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Basic information
Public title A randomized phase 2 study of Docetaxel with or without Bevacizumab after platinum-based chemotherapy plus bevacizumab in patients with advanced non-squamous non-small-cell lung cancer
Acronym A randomized phase 2 study of Docetaxel with or without Bevacizumab after platinum-based chemotherapy plus bevacizumab in patients with advanced non-squamous non-small-cell lung cancer
Scientific Title A randomized phase 2 study of Docetaxel with or without Bevacizumab after platinum-based chemotherapy plus bevacizumab in patients with advanced non-squamous non-small-cell lung cancer
Scientific Title:Acronym A randomized phase 2 study of Docetaxel with or without Bevacizumab after platinum-based chemotherapy plus bevacizumab in patients with advanced non-squamous non-small-cell lung cancer
Region
Japan

Condition
Condition Non-small cell lung cancer
Classification by specialty
Pneumology Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To assess the efficacy and safety of Docetaxel plus Bevacizumab after failure of platinum-based chemotherapy plus bevacizumab in patients with advanced non-squamous non-small-cell lung cancer
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Progression free survival
Key secondary outcomes Response rate, Overall Survival, Safety

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Docetaxel
Interventions/Control_2 Docetaxel plus Bevacizumab
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

Not applicable
Gender Male and Female
Key inclusion criteria 1) Patients with stage 3b/4 or recurrent non-squamous NSCLC who have progressed on one prior treatment with a platinum-based chemotherapy plus bevacizumab
* A patient who has received pre- or postoperative chemotherapy is eligible if the last administration of the prior adjuvant regimen occurred at least 12 months prior to platinum-based chemotherapy plus bevacizumab.
* A patient with history of treatment with EGFR-TKI (gefitinib or erlotinib) priot platinum-based chemotherapy plus bevacizumab is eligible if the patient had an EGFR mutation
2) Cytologically or histologically documented non-squamous cell carcinoma of the lung
3) More than 21 days since prior chemotherapy
* A patient who has received platinum plus gemcitabine with bevacizumab is eligible if more than 21 days have passed since the last administration of platinum and bevacizumab, and more than 14 days of gemcitabine.
* A patient who has received platinum plus S-1 with bevacizumab is eligible if more than 21 days have passed since the last administration of platinum and bevacizumab, and more than 7 days of S-1.
4) Life expectancy of at least 3 months
5) Age eligible for study: 20 years and above
6) ECOG performance status of 0 to 2
7) Have measurable lesion in a previously non-irradiated area according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
8) Have adequate organ function
9) Provide written informed consent
Key exclusion criteria 1) Prior treatment with docetaxel
2) Have central nervous system metastases (A patient who has previously treated brain metastases, without evidence of progression or hemorrhage at baseline is eligible)
3) Currently have or have a history of hemoptysis (>= one-half teaspoon of bright red blood per event)
4) Clinically significant drug allergy
5) Have a evidence of thrombosis
6) Have a serious concomitant active infection, which needs antibiotics, antimycotic drugs or virucide
7) Have a history of serious systemic disease including: clinically significant cardiovascular disease; medically uncontrolled diabetes and hypertension; gastrointestinal perforation, gastroparesis, or obstruction
8) Uncontrolled effusion (Pleural, peritoneal effusion, or cardiac effusion which requires drainage for symptom management)
Regarding the patient who have or have had pleural effusion;
a) A patients who developed recurrent effusion within two weeks after drainage tube removal is ineligible
b) A patient who received intrapleural chemotherapy (excluding BRM such as OK432) for pleurodesis is ineligible
9) Patients with or with anticipation of invasive procedures as defined below:
a) Major surgery within four weeks of registration
b) Palliative radiotherapy within two weeks of registration
c) Minor surgical procedures, core biopsy or traumatic injury, within two weeks of registration
d) Transfusion of any blood products within two weeks of registration
10) Have another active malignancy
11) Interstitial pneumonia or pulmonary fibrosis documented obviously in chest X ray
12) Mental disease or psychotic manifestation
13) Pregnant or beeast-feeding woman or patient who doesn't agree to contraception
14) Not suitable for participating in the study for any other reason
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masayuki Takeda
Organization Kinki University Faculty of Medicine
Division name Department of Medical Oncology
Zip code
Address 377-2 Ohno-higashi, Osaka-Sayama,Osaka 589-8511, Japan
TEL 072-366-0221
Email takedamasa2004@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shinichiro Nakamura
Organization West Japan Oncology Group
Division name WJOG datacenter
Zip code
Address Nanma Plaza Bldg. 304-1-5-7, Motomachi Naniwa-ku, Osaka556-0016 JAPAN
TEL 06-6633-7400
Homepage URL
Email datacenter@wjog.jp

Sponsor
Institute West Japan Oncology Group
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
Address
Tel
Email

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
2010 Year 12 Month 13 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://www.ncbi.nlm.nih.gov/pubmed/26828788
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 20 Day
Date of IRB
Anticipated trial start date
2011 Year 02 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2010 Year 12 Month 13 Day
Last modified on
2016 Year 03 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005610

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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