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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004263
Receipt No. R000005112
Scientific Title A feasibility study of Pemetrexed/Bevacizumab in elderly patients with advanced non-small cell lung cancer (TORG1015)
Date of disclosure of the study information 2010/09/25
Last modified on 2016/05/13

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Basic information
Public title A feasibility study of Pemetrexed/Bevacizumab in elderly patients with advanced non-small cell lung cancer (TORG1015)
Acronym TORG1015
Scientific Title A feasibility study of Pemetrexed/Bevacizumab in elderly patients with advanced non-small cell lung cancer (TORG1015)
Scientific Title:Acronym TORG1015
Region
Japan

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

Objectives
Narrative objectives1 To evaluate recommended dose of Pemetrexed and bevacizumab combination therapy in elderly patients with non-small cell lung cancer.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Toxicity
Key secondary outcomes Response rate,
Progression-free survival,
Overall survival,
Completion proportion of 3 cycles

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 Bevacizumab plus Pemetrexed administrated on day 1 every 3 weeks
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
70 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1. Patients with pathologically proven non-squamous non-small cell lung cancer.
2. Patients with StageIIIB/IV or recurrence non-small cell lung cancer and were not a candidate for curative radiotherapy.
3. Patients previously treated with chemotherapy (except EGFR-TKI for first line therapy and UFT for postoperative adjuvant chemotherapy).
4. Performance Status (ECOG) 0-1
5. Patients who have at least one or more measurable lesion by RECIST(Version1.1).
6. Patients aged 70 years or older.
7. Ineligible for standard cisplatin(bolus infusion)-containing combination chemotherapy.
8. Sufficient function of main organ and bone marrow filled the following criteria.
Leukocyte counts >= 4,000/mm3
Neutrophil counts >= 2,000/mm3
Platelets >= 100,000/mm3
Hemoglobin concentration >= 9.5 g/dL
AST and ALT, x 2.5 of upper limit of normal (ULN) or less
Total bilirubin, 1.5mg/dL or less
Serum creatinin, 1.2mg/dL or less
SpO2 93% or above
proteinuria, 1+ or less
9. interval
(1) radiation therapy
more than 2 weeks after the last radiation therapy for nonthoracic region
(2) operation.
More than 8 weeks after the last operation with pulmonary resection.
More than 4 weeks after the last operation without pulmonary resection.
More than 2 weeks after the last pleurodesis or thoracic cavity drainage.
10. Patients providing written informed consent.
Key exclusion criteria 1. Patients with brain metastasis.
2. Patients with current or previous hemoptysis.
3. Patients treated with radiation therapy for thoracic region.
4. Patients with active severe infections.
5. Patients who have fever of over 38 degrees.
6. Patients with serious complication (cardiac affection, interstitial pneumonia, uncontrollable hypertension, or uncontrollable diabetes mellitus, etc.)
7. Patients with massive ascites, pleural or pericardial effusion.
8. Patients with concomitant malignancy.
9. Patients with history of drug allergies.
10. Patients with uncontrollable gastrointestinal ulceration.
11. Patients with current or previous (within one year) history of gastrointestinal perforation.
12. Patients treated with anticoagulation therapy.
13. Inappropriate patients for this study judged by the physicians.
Target sample size 12

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tetsu Shinkai
Organization National Hospital Organization Shikoku Cancer Center
Division name Department of thoracic oncology
Zip code
Address 160 Kou Minamiumemoto-machi, Matsuyama, Ehime
TEL 089-999-1111
Email

Public contact
Name of contact person
1st name
Middle name
Last name Naoyuki Nogami, Toshiyuki Kozuki
Organization National Hospital Organization Shikoku Cancer Center
Division name Department of thoracic oncology
Zip code
Address 160 Kou Minamiumemoto-machi, Matsuyama, Ehime
TEL
Homepage URL
Email

Sponsor
Institute Thoracic Oncology Research Group
Institute
Department

Funding Source
Organization Thoracic Oncology Research Group
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization JAPAN

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 独立行政法人国立病院機構 四国がんセンター(愛媛県)
藤沢市民病院(神奈川県)
千葉大学医学部附属病院 (千葉県)
茨城県立中央病院(茨城県)
日本医科大学千葉北総病院(千葉県)
神奈川県立循環器呼吸器病センター(神奈川県)
神戸赤十字病院(兵庫県)

Other administrative information
Date of disclosure of the study information
2010 Year 09 Month 25 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://www.biomedcentral.com/1471-2407/16/306/abstract
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 09 Month 16 Day
Date of IRB
Anticipated trial start date
2010 Year 09 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 09 Month 24 Day
Last modified on
2016 Year 05 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005112

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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