Safety and feasibility study of hyper short-hydration with furosemide in cisplatin combinated chemotherapy

UMIN ID: UMIN000023176

Registered date:14/07/2016

Basic Information

• Recruitment status: Open public recruiting
• Health condition(s) or Problem(s) studied: Non-small cell lung cancer
• Date of first enrollment: 2016/07/14
• Target sample size: 32
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Hyper short-hydration therapy with cisplatin/pemetrexed, cisplatin/pemetrexed/bevacizumab, or cisplatin/gemcitabine

Outcome(s)

• Primary Outcome: 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.

Secondary Outcome

･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

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 75years-old
• Gender: Male and Female

Include criteria

(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)

Exclude criteria

(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

Related Information

• Primary Sponsor: Kurashiki central hospital
• Source(s) of Monetary Support: Kurashiki central hospital