Unique ID issued by UMIN | UMIN000023176 |
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Receipt number | R000026653 |
Scientific Title | Safety and feasibility study of hyper short-hydration with furosemide in cisplatin combinated chemotherapy |
Date of disclosure of the study information | 2016/07/14 |
Last modified on | 2016/07/14 22:16:37 |
Safety and feasibility study of hyper short-hydration with furosemide in cisplatin combinated chemotherapy
Hyper short-hydration of cisplatin
Safety and feasibility study of hyper short-hydration with furosemide in cisplatin combinated chemotherapy
Hyper short-hydration of cisplatin
Japan |
Non-small cell lung cancer
Pneumology | Hematology and clinical oncology |
Malignancy
NO
To evaluate the safety and feasibility of the cisplatin containing chemotherapy with hyper short-hydration in patients with non-small cell lung cancer (NSCLC).
Safety
Exploratory
Phase II
The proportion of patients without renal dysfunction, defined as the proportion of patients without a Grade 2 or higher elevation in creatinine from the baseline value after first-cycle.
・The proportion of patients without a Grade 2 or higher elevation in creatinine from the baseline value after all cycles
・Adverse events
・Creatinine, eGFR and Ccr after six months from the start of treatment
・The overall response rate
・Progression-free survival
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Hyper short-hydration therapy with cisplatin/pemetrexed, cisplatin/pemetrexed/bevacizumab, or cisplatin/gemcitabine
20 | years-old | <= |
75 | years-old | > |
Male and Female
(1)Histologically or cytologically proven non-squamous NSCLC
(2)Clinical stage IIIB (not amenable to curative radiation or surgery), IV or recurrent disease
(3)Regardless of the presence of mesurable lesions
(4) Age of 20 years or older and younger than 75 years at the time of consent
(5)Patients who had not received any prior cytotoxic systemic chemotherapy
(If patients have received adjuvant chemotherapy, the patients who experience recurrence after 6 months are permitted.)
(6)Patients who do not need palliative radiotherapy or drainage concurrently with systemic chemotherapy
(7)Patients who have not received ratiotherapy to the primary lesion
(8)More than 4 weeks after the last operation
(9)ECOG Performance Status (PS) 0-1
(10)Have adequate organ function within 14 days before study entry
(11)Estimated life expectancy at least 3 months
(12)Written informed consent
[the case of CDDP/PEM/BEV]
(13)Proteinuria 0 - 1+
(14)PT-INR 1.5 or less (except for patients received preventive anticoagulation therapy)
(1)Having serious complications
(2)Have any evidence of interstitial lung disease on chest X-ray or CT
(3)Have another active malignancy
(4)Currently have a cardiac or a thoracic effusion which requires treatment
(5)Pregnant or lactating woman
(6)Positive for HBs antigen
(7)Patients whose participation in the trial is judged to be inappropriate by the doctor
[the case of CDDP/PEM/BEV]
(8)History of pulmonary hemorrhage/hemoptysis defined as bright red blood of at least 2.5mL
(9)Have possibly complication related to bleeding episode
(10)Evidence of tumor invading a perihilar blood vessel, heart and major blood vessel on imaging, or evidence of cavitation in intra-thoracic lesion
(11)Evidence of tumor invading segmental bronchus
(12)Uncontrollable hypertention
32
1st name | |
Middle name | |
Last name | Hiroshige Yoshioka |
Kurashiki central hospital
Department of Respiratory Medicine
Miwa1-1-1, Kurashiki, Okayama, Japan
086-422-0210
hirotin@kchnet.or.jp
1st name | |
Middle name | |
Last name | Tae Tanaka |
Kurashiki central hospital
Department of Respiratory Medicine
Miwa1-1-1, Kurashiki, Okayama, Japan
086-422-0210
tt14837@kchnet.or.jp
Kurashiki central hospital
Kurashiki central hospital
Self funding
NO
先端医療センター病院(兵庫県)、倉敷中央病院(岡山)
2016 | Year | 07 | Month | 14 | Day |
Unpublished
Open public recruiting
2016 | Year | 06 | Month | 22 | Day |
2016 | Year | 07 | Month | 14 | Day |
2016 | Year | 07 | Month | 14 | Day |
2016 | Year | 07 | Month | 14 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026653
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