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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000003949
Receipt No. R000004739
Scientific Title A phase II study of Bevacizumab combined with Carboplatin and Weekly Paclitaxel for Patients with Advanced Non-Squamous Non-Small-Cell Lung Cancer. North Japan Lung Cancer Study Group Trial 1002
Date of disclosure of the study information 2010/07/31
Last modified on 2011/03/31

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Basic information
Public title A phase II study of Bevacizumab combined with Carboplatin and Weekly Paclitaxel for Patients with Advanced Non-Squamous Non-Small-Cell Lung Cancer. North Japan Lung Cancer Study Group Trial 1002
Acronym CBDCA+wPTX+BEV Phase II NJLCG1002
Scientific Title A phase II study of Bevacizumab combined with Carboplatin and Weekly Paclitaxel for Patients with Advanced Non-Squamous Non-Small-Cell Lung Cancer. North Japan Lung Cancer Study Group Trial 1002
Scientific Title:Acronym CBDCA+wPTX+BEV Phase II NJLCG1002
Region
Japan

Condition
Condition non-squamous non-small-cell lung cancer
Classification by specialty
Pneumology Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 To evaluate the efficacy and safety of bevacizumab combined with carboplatin and weekly paclitaxel for 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 response rate, adverse events
Key secondary outcomes progression free survival, overall survival

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 CBDCA (AUC=6, div) on day1, Bevacizumab (15mg/kg, div) on day1 and Paclitaxel (70mg/m2, div) on days 1, 8, 15 every 4 weeks, up to 6 cycles.
Patients who achieve disease control (response or stable disease) are permitted Bevacizumab (15mg/kg, div) administration on day 1, every 3 weeks until disease progression.
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
74 years-old >=
Gender Male and Female
Key inclusion criteria 1) Histologically or cytologically confirmed non-squamous, non-small cell lung cancer (Non-Squamous NSCLC).
2) Stage III/IV unresectable or unsuitable for radical irradiation or postoperative recurrent Non-Squamous NSCLC.
3) Chemotherapy naive and thoracic irradiation naive patients.
*UFT adjuvant therapy is acceptable.
*OK-432 therapy is acceptable for pleuridesis procedure.
*Extrathoracic irradiation is acceptable, if it was completed more than two weeks before enrollment.
4) ECOG-PS of 0 or 1.
5) Age: 20-74 years old.
6) Measurable by RECIST ver.1.1 criteria.
7) Adequate organ function.
WBC >= 4,000/mm3
(Or Neutrophil >= 2,000/mm3)
Hb >= 9.0g/dl
Platelet >= 100,000/mm3
T-Bil <= 1.5g/dl
GOT (AST), GPT (ALT) < 100 IU/l
Serum Cr <= 1.5mg/dl
Ccr >= 40 ml/min (calculated by Cockcroft-Gault formula)
8) Life expectancy more than 3 months.
9) Written informed consent.
Key exclusion criteria 1) Clinically active interstitial pneumonia or pulmonary fibrosis, detectable on CT scan.
2) Uncontrollable pleural or pericardial effusion or ascites.
3) Current or previous hemoptysis (>=1 teaspoon).
4) Brain metastasis.
5) Tumor invading thoracic major vessel.
6) Tumor with cavity.
7) Severe co-morbidities (ex. uncontrolled heart or lung or hepatic or renal disease or diabetes).
8) Regular use of corticosteroid (less than 2 weeks interval after cessation).
9) Active gastrointestinal ulcer.
10) Peripheral sensory neuropathy >= Grade 2.
11) Pregnancy or lactation, or those who decline contraception.
12) Hypersensitivity of Taxans or alcohol and the medicine made of the polio castor oil content.
13) Active concomitant malignancy. Except carcinoma in situ or those who did not relapse 5-years or more.
14) Contraindication with carboplatin or paclitaxel or bevacizumab.
15) Those judged to be not suitable by the attending physician.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Nobumichi Matsubara
Organization Miyagi Cancer Center
Division name Dept. of Respiratory Medicine
Zip code
Address 47-1 Nodayama, Medeshima-shiote, Natori, Miyagi, JAPAN. 981-1293
TEL 022-384-3151
Email

Public contact
Name of contact person
1st name
Middle name
Last name Makoto Maemondo
Organization Miyagi Cancer Center
Division name Dept. of Respiratory Medicine
Zip code
Address 47-1 Nodayama, Medeshima-shiote, Natori, Miyagi, JAPAN. 981-1293
TEL 022-384-3151
Homepage URL
Email

Sponsor
Institute Miyagi Cancer Center
Institute
Department

Funding Source
Organization Miyagi Cancer Center
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 YES
Study ID_1 NJLCSG 1002
Org. issuing International ID_1 North Japan Lung Cancer Study Group
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 07 Month 31 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 Terminated
Date of protocol fixation
2010 Year 07 Month 20 Day
Date of IRB
Anticipated trial start date
2010 Year 08 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 07 Month 26 Day
Last modified on
2011 Year 03 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004739

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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