UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000010055
Receipt No. R000010954
Scientific Title Phase II study evaluating the efficacy and safety of the Bevacizumab / Docetaxel maintenance therapy beyond stable disease in patients with advanced relapsed non-squamous NSCLC who received Bevacizumab / pemetrexed / platinum induction therapy
Date of disclosure of the study information 2013/02/18
Last modified on 2013/02/17

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Phase II study evaluating the efficacy and safety of the Bevacizumab / Docetaxel maintenance therapy beyond stable disease in patients with advanced relapsed non-squamous NSCLC who received Bevacizumab / pemetrexed / platinum induction therapy
Acronym Phase II study evaluating the efficacy and safety of the Bevacizumab / Docetaxel maintenance therapy beyond stable disease in patients with advanced relapsed non-squamous NSCLC who received Bevacizumab / pemetrexed / platinum induction therapy
Scientific Title Phase II study evaluating the efficacy and safety of the Bevacizumab / Docetaxel maintenance therapy beyond stable disease in patients with advanced relapsed non-squamous NSCLC who received Bevacizumab / pemetrexed / platinum induction therapy
Scientific Title:Acronym Phase II study evaluating the efficacy and safety of the Bevacizumab / Docetaxel maintenance therapy beyond stable disease in patients with advanced relapsed non-squamous NSCLC who received Bevacizumab / pemetrexed / platinum induction therapy
Region
Japan

Condition
Condition advanced relapsed non-squamous NSCLC
Classification by specialty
Medicine in general Pneumology Surgery in general
Chest surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluating the efficacy and safety of the Bevacizumab / Docetaxel maintenance therapy beyond stable disease in patients with advanced relapsed non-squamous NSCLC who received Bevacizumab / pemetrexed / platinum induction therapy
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Progression free survival
Key secondary outcomes Response rate, Time to response, Disease control rate, Overall survival, Compare PFS with the change in tumor size from baseline in PFS, Compare SMT with CMT in PFS, Safety

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 If the disease is stable after four courses of CBDCA+PEM+BEV as induction therapy, patients will be treated with DTX+BEV as maintenance therapy until progression disease.
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
80 years-old >
Gender Male and Female
Key inclusion criteria 1. Patients at the age of 20 to 80
2. Confirmed as Stage3B(unsuitable for definitive radiotherapy), Stage4, or recurrent patient
3. non-squamous NSCLC
4. Patients with life expectancy for more than 3 months
5. During induction chemotherapy, Eastern Cooperative Oncology Group performance status of 0-1
During maintenance chemotherapy, Eastern Cooperative Oncology Group performance status of 0-2
6. Patients with measurable disease based on Response Evaluation Criteria in Solid Tumors(RECIST)ver.1.1.
* radiation sites are not counted as measurable lesions
7. Patients with adequate organ function as following
Neutrocyte count >= 1500/mm3
Platelet count>= 100,000/mm3
Hemoglobin >= 9.0 g/dL
Aspartate aminotransferase and alanine aminotransferase < 2.5 times the upper limit of normal
Total bilirubin <= 1.5mg/dL
Serum creatinine <= 1.5mg/dL
PT-INR<1.5
Ccr >= 60mL/min(CDDP), 45mL/min(CBDCA)
Urine protein<=+1
* Confirmed by test results within 2 weeks before registration date. The same day of the week 2 weeks before enrollment cannot be included
8. At the time of the expected date of the beginning of treatment, patients with the following period has elapsed since prior treatments
No radiotherapy except for thoracic radiation within a week (exclude chest)
No Exploratory thoracotomy within 4 weeks
No pleural drainage within a week
9. Written informed consent can be obtained.
Key exclusion criteria 1. Patients with symptomatic brain metastases.
2. Patients with history or complication of hemoptysis.
*Definition of hemoptysis is determined by the following.
A history of continuous hemoptysis over one week, or hemoptysis receiving oral or intravenous hemostatic medicine.
3. Patients with a history of severe drug allergy.
4. Patients with uncontrolled ascites, pleural effusion, or pericardial effusion
5. Patients with a history of gastrointestinal perforation within an year, or a complication of uncontrollable peptic ulcer.
6. Patients with uncontrolled hypertension
7. Patients with infectious disease requiring systemic administration of antiviral agents, antifungal agents, or antibiotics.
8. Patients receiving anticoagulant therapy
9. Patients receiving antiplatelet therapy
*Patients receiving aspirin therapy up to 325mg are allowed to be registered.
10. Patients with a history of radiation to the chest, or more than 20% region of bones with hematopoietic ability
11. Patients with multiple cancers within 5years prior to initiation of the study, except for carcinoma in situ, mucosal cancer appropriately treated non-melanoma, cervical cancer, thyroid cancer, early gastric cancer, early colorectal cancer.
12. Patients with serious complications (such as heart disease, active infection, interstitial pneumonia, diabetes)
13. Pregnant woman or those with suspected pregnancy, nursing woman and those who plan to become pregnant during the study period.
14. Other patients whom the investigation considers to be unsuitable for participation in the study.
15. Patients treated with EGFR-TKI
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kyoko Fujisaki
Organization Showa University Northern Yokohama Hospital
Division name Respiratory Center
Zip code
Address Chigasaki-chuo 35-1 Tsuzuki-ku, Yokohama 224-503, Japan.
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Kyoko Fujisaki
Organization Showa University Northern Yokohama Hospital
Division name Respiratory Center
Zip code
Address Chigasaki-chuo 35-1 Tsuzuki-ku, Yokohama 224-503, Japan.
TEL
Homepage URL
Email

Sponsor
Institute Respiratory Center, Showa University Northern Yokohama Hospital
Institute
Department

Funding Source
Organization Mone
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
2013 Year 02 Month 18 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 Open public recruiting
Date of protocol fixation
2012 Year 11 Month 01 Day
Date of IRB
Anticipated trial start date
2013 Year 02 Month 18 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
2013 Year 02 Month 17 Day
Last modified on
2013 Year 02 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010954

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.