Unique ID issued by UMIN | UMIN000011095 |
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Receipt number | R000012669 |
Scientific Title | A Multicenter phase II study of Carboplatin/Pemetrexed/Bevacizumab in First-Line Treatment of Elderly Patients with Advanced Non-squamous and Non-small Cell Lung cancer |
Date of disclosure of the study information | 2013/07/02 |
Last modified on | 2018/07/06 14:53:24 |
A Multicenter phase II study of Carboplatin/Pemetrexed/Bevacizumab in First-Line Treatment of Elderly Patients with Advanced Non-squamous and Non-small Cell Lung cancer
Phase II study of CBDCA/PEM/BEV in elderly NSCLC
A Multicenter phase II study of Carboplatin/Pemetrexed/Bevacizumab in First-Line Treatment of Elderly Patients with Advanced Non-squamous and Non-small Cell Lung cancer
Phase II study of CBDCA/PEM/BEV in elderly NSCLC
Japan |
Non-squamous non-small cell lung cancer
Pneumology |
Malignancy
NO
To evaluate the efficacy and safety of the combination of CBDCA/PEM/BEV in elderly patients with non-sq NSCLC.
Safety,Efficacy
Phase II
Response rate
Interventional
Single arm
Non-randomized
Open -no one is blinded
Historical
1
Treatment
Medicine |
CBDCA+PEM+Bevacizumab
75 | years-old | <= |
Not applicable |
Male and Female
1) In histological or cytological diagnosis, diagnosis of the non-squamous and
non-small cell lung cancer is obtained
2) More than 75 years old at the time of the agreement acquisition
3) Eastern Cooperative Oncology Group (ECOG)Performance Status (PS) 0-1
4) With the measurable disease based on Response Evaluation Criteria in solid Tumors (RECIST) v. 1.1
5) There is not systemic chemotherapy history for non-squamous cell and small cell carcinoma, expect UFT for adjuvant therapy or therapy for pleurodesis and first line of EGFR-TKI or Crizotinib
6) With adequate organ function within one week before study entry
7) The expected survival more than 90 days from the enrollment
8) An agreement by the document from a patient
1) The case that there is previous treatment history
2) With the active double primary cancer
3) With the pleural effusion or pericardial effusion to need drainage
4) With the metastatic brain tumor to need treatment, such as radiotherapy or steroid
5) History of active hemoptysis with 2,5 ml or more
6) The case that a hemorrhage risk is high
a) With the necessity of the administration of anticoagulant and antiplatelet agent
b) With the the tumor invasion to great vessels
c) With the cavity lesion
7) With the following complication or past history
a) With the merger or history of cerebrovascular disease to need treatment
b) With the history of perforation gastrointestinal, fistula, diverticulitis
c) With the diarrhea, paresis of intestine, ileus
d) With the merger or history of angina or myocardial infarction, cardiac failure to need treatment
e) With the uncontrol diabetes
f) With the interstitial pneumonia
g) With the uncontrol infectious disease
h) With the history of serious drug allergy
i) With the uncontrol hypertension even if taking the hypotensive drug
8) With the mental disease
9) The patient whom attending physician judged to be inadequate to perform the
study treatment safely
42
1st name | |
Middle name | |
Last name | Kazuhiko Yamada |
Department of Internal Medicine, Kurume University School of Medicine
Division of Respirology, Neurology, and Rheumatology
67 Asahi-machi, Kurume, Fukuoka
0942-31-7560
kayamada@med.kurume-u.ac.jp
1st name | |
Middle name | |
Last name | Kazuhiko Yamada |
Department of Internal Medicine, Kurume University School of Medicine
Division of Respirology, Neurology, and Rheumatology
67 Asahi-machi, Kurume, Fukuoka
0942-31-7560
kayamada@med.kurume-u.ac.jp
Kurume University School of Medicine
Kurume University School of Medicine
Self funding
NO
久留米大学病院(福岡県)、九州医療センター(福岡県)
2013 | Year | 07 | Month | 02 | Day |
Published
Terminated
2013 | Year | 06 | Month | 01 | Day |
2013 | Year | 06 | Month | 01 | Day |
2013 | Year | 07 | Month | 02 | Day |
2018 | Year | 07 | Month | 06 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012669
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