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

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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000017576

Enrollment

Registered

2015-05-14

Start date

2008-01-09

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

colorectal cancer

Interventions

3-day indisetron regimen 1-day indisetron regimen

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. patients with advanced or metastatic colorectal cancer 2. scheduled to receive full dose of mFOLFOX6 as 1st line chemotherapy, with or without targeted agents 3. age 20-80 years old 4. ECOG performance status 0-2 5. written informed consent

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Complete protection from vomiting	—

Secondary

Measure	Time frame
Complete protection from nausea No use of rescue therapy Tolerability	—

Countries

Japan

Contacts

Public ContactHiroshi Nakatsumi

Hokkaido University Hospital Gastroenterology and Hepatology

tsumi1979@gmail.com81-11-706-5657

Outcome results

None listed

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