Randomized pilot study of optimal dose period for indisetron tablets for preventing chemotherapy-induced nausea and vomiting with mFOLFOX6: HGCSG0703

Phase 2

• Conditions: colorectal cancer

• Registration Number: JPRN-UMIN000017576
• Lead Sponsor: Hokkaido Gastrointestinal Cancer Study Group (HGCSG)

Brief Summary

Proportions of patients with complete protection from vomiting were 85.7% (95% confidence interval (CI), 63.7-97.0%) with the 3-day regimen, and 81.0% (95%CI, 58.1-94.6%) with the 1-day regimen. Proportions of patients with complete protection from nausea were 47.6% in each arm (95%CI, 25.7-70.2%). No rescue therapy rates were 66.7% (95%CI, 43.0-85.4%) vs. 57.1% (95%CI, 34.0-78.2%). No severe adverse events were observed in either arm.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2009-09-04
• Study Start: 2015-05-14
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

Exclusion Criteria

1. had any known central nervous system malignancy 2. had any seizure disorder needing anticovulsants 3. had active gastrointestinal ulcers or obstruction 4. had any other organic cause of nausea or vomiting unrelated to chemotherapy 5. were scheduled to undergo radiotherapy 6. were pregnant or nursing women 7. had any history of drug hypersensitivity

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Complete protection from vomiting

Secondary Outcome Measures

Name	Time	Method
Complete protection from nausea No use of rescue therapy Tolerability