A randomized phase II study of furosemide or mannitol in cisplatin-based chemotherapy using short hydration

JRCT ID: jRCTs051180015

Registered date:19/12/2018

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Cisplatin naive thoracic malignancy
• Date of first enrollment: 11/05/2018
• Target sample size: 115
• Study type: Interventional

Intervention(s)

Standard treatment group (Group A): 300 ml of 20% mannitol is intravenously administered over 30 minutes.
Study treatment group (Group B): Furosemide 20 mg is administered intravenously.

Outcome(s)

• Primary Outcome: The proportion of patients who experienced >= Grade 1 renal dysfunction during the first cycle

Secondary Outcome

1) The proportion of patients who experienced >= Grade 2 renal dysfunction during the first cycle
2) The proportion of patients who experienced >= Grade 1 renal dysfunction during the first cycle (defined as elevation in creatinine, CTCAE Ver. 4.0, based on the pretreatment baseline creatinine score in each patient)
3) The proportion of patients who experienced >= Grade 2 renal dysfunction during the first cycle (defined as elevation in creatinine, CTCAE Ver. 4.0, based on the pretreatment baseline creatinine score in each patient)
4) The proportion of patients who experienced >= Grade 1 renal dysfunction from the first to the fourth cycle
5) The proportion of patients who experienced >= Grade 2 renal dysfunction from the first to the fourth cycle
6) The proportion of patients who experienced >= Grade 1 renal dysfunction after the completion of the fourth cycle (defined as elevation in creatinine, CTCAE Ver. 4.0, based on the ULN for serum creatinine at each institute and on the pretreatment baseline creatinine score in each patient)
7) The proportion of patients who experienced >= Grade 2 renal dysfunction after the completion of the fourth cycle (defined as elevation in creatinine, CTCAE Ver. 4.0, based on the ULN for serum creatinine at each institute and on the pretreatment baseline creatinine score in each patient)
8) Frequency and severity of phlebitis

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 74age old
• Gender: Both

Include criteria

1)Thoracic malignancy
2)Age 20-75 years
3)ECOG Performance status 0-1
4)Patients can be administered cisplatin(Data from within two weeks before the date of registration may be used)
Serum creatinine level <= 1.2mg/dL
Creatinine clearance rate of >= 60mL/min(based on 24-hour collection of urine or calculated using Cockcroft and Gault's formula, below)
Males:((140-age)x weight(kg))/(72x serum creatinine(mg/dL))
Females:0.85x ((140-age)x weight(kg))/(72x serum creatinine(mg/dL))
5)Able to ingest 1L or more of liquid per day
6)Cardiac activity is maintained (EF>=60%)
7)Signed and dated informed consent

Exclude criteria

1) Serious complications (gastrointestinal bleeding/heart disease/glaucoma)
2) Hypersensitivity to cisplatin / mannitol / furosemide
3) Superior Vena Cava syndrome
4) Psychiatric disorder
5) Breast-feeding or pregnant/possibly pregnant, or woman who does not agree to prevent conception
6) Patients who are otherwise judged to be ineligible for enrolment by investigators

Related Information

• Primary Sponsor: Yamamoto Nobuyuki
• Secondary ID(s): UMIN000031910