UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003949 |
|---|---|
| Receipt number | 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 13:04:47 |
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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
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
Sponsor or person
Institute
Miyagi Cancer Center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004739
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