UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004263 |
|---|---|
| Receipt number | 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 00:22:34 |
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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
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
Sponsor or person
Institute
Thoracic Oncology Research Group
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005112
