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

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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000031910

Enrollment

115

Registered

2018-04-01

Start date

2018-05-07

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chemotherapy naive thoracic malignancy

Interventions

20% mannitol 300ml, in 30min furosemide 20mg, intravenous infusion

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)Thoracic malignancy 2)ECOG PS 0-1 3)Creatinine clearance rate of >=60mL/min 4)Previously untreated with cisplatin-based chemotherapy

Exclusion criteria

Exclusion criteria: With Superior Vena Cava syndrome

Design outcomes

Primary

Measure	Time frame
The proportion of patients experienced >=Grade1 renal dysfunction during the first cycle (defined as elevation in creatinine, CTCAE Ver. 4.0, based on the upper limit of the normal range (ULN) for serum creatinine at each institute)	—

Secondary

Measure	Time frame
1)The proportion of patients experienced >=Grade2 renal dysfunction during the first cycle (defined as elevation in creatinine, CTCAE Ver. 4.0, based on the ULN for serum creatinine at each institute) 2) The proportion of patients experienced >=Grade1 and >=Grade2 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 experienced >=Grade1 and >=Grade2 renal dysfunction after the completion of forth 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) 4)The proportion of patients with phlebitis and severity	—

Measure

Time frame

1)The proportion of patients experienced >=Grade2 renal dysfunction during the first cycle (defined as elevation in creatinine, CTCAE Ver. 4.0, based on the ULN for serum creatinine at each institute) 2) The proportion of patients experienced >=Grade1 and >=Grade2 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 experienced >=Grade1 and >=Grade2 renal dysfunction after the completion of forth 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) 4)The proportion of patients with phlebitis and severity

—

Countries

Japan

Contacts

Public ContactEriko Murakami

Wakayama Medical University Third Department of Internal Medicine

erikom@wakayama-med.ac.jp0734410619

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026