Unique ID issued by UMIN | UMIN000004240 |
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Receipt number | R000005099 |
Scientific Title | A feasibility study of Docetaxel/Bevacizumab in elderly patients with advanced non-small cell lung cancer (TORG1014) |
Date of disclosure of the study information | 2010/09/24 |
Last modified on | 2014/03/22 09:01:27 |
A feasibility study of Docetaxel/Bevacizumab in elderly patients with advanced non-small cell lung cancer (TORG1014)
TORG1014
A feasibility study of Docetaxel/Bevacizumab in elderly patients with advanced non-small cell lung cancer (TORG1014)
TORG1014
Japan |
Non-small cell lung cancer
Pneumology |
Malignancy
NO
To evaluate recommended dose of Docetaxel and Bevacizumab combination therapy in elderly patients with non-small cell lung cancer.
Safety
Exploratory
Not applicable
Toxicity
Response rate,
Progression-free survival,
Overall survival,
Completion proportion of 3 cycles
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Bevacizumab plus Docetaxel
70 | years-old | <= |
Not applicable |
Male and Female
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, x2 of upper limit of normal (ULN) or less
Total bilirubin, 1.5mg/dL or less
Serum creatinin, x 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.
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
12
1st name | |
Middle name | |
Last name | Yukio Hosomi |
Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital
Division of Respiratory Medicine
18-22, Honkomagome 3cho-me, Bunkyo-ku, Tokyo
03-3823-2101
yhosomi@cick.jp
1st name | |
Middle name | |
Last name | Yukio Hosomi |
Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital
Division of Respiratory Medicine
18-22, Honkomagome 3cho-me, Bunkyo-ku, Tokyo
03-3823-2101
http://www.torg.or.jp/testing.html
yhosomi@cick.jp
Thoracic Oncology Research Group(TORG)
Thoracic Oncology Research Group(TORG)
Self funding
NO
2010 | Year | 09 | Month | 24 | Day |
Unpublished
Completed
2010 | Year | 09 | Month | 21 | Day |
2010 | Year | 09 | Month | 01 | Day |
2010 | Year | 09 | Month | 21 | Day |
2014 | Year | 03 | Month | 22 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005099
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