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

Phase 2

• Conditions: Chemotherapy naive thoracic malignancy

• Registration Number: JPRN-UMIN000031910
• Lead Sponsor: Wakayama Medical University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-04-01
• Study Completion: 2023-01-31
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up continuing
• Sex: All
• Target Recruitment: 115

Inclusion Criteria

Not provided

Exclusion Criteria

With Superior Vena Cava syndrome

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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