Randomized pilot study evaluating indisetron tablets for the prevention of acute-onset diarrhea, nausea and vomiting with IRIS or FOLFIRI for metastatic colorectal cancer patients: HGCSG 0704

Randomized pilot study evaluating indisetron tablets for the prevention of acute-onset diarrhea, nausea and vomiting with IRIS or FOLFIRI for metastatic colorectal cancer patients: HGCSG 0704 - Randomized study to explore indisetron for the prevention of acute-onset diarrhea, nausea, vomiting with IRIS/FOLFIRI: HGCSG 0704

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000010162

Enrollment

Registered

2013-03-10

Start date

2008-04-01

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

indisetrone garnisetrone

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. with advanced or metastatic colorectal cancer 2. scheduled to receive the IRIS or FOLFIRI, with or without molecular targeted agents 3. age 20&#8211;80 years 4. ECOG PS 0&#8211;2 5. written informed consent

Exclusion criteria

Exclusion criteria: 1. had any known central nervous system malignancy 2. had any seizure disorder needing anticonvulsants 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
Incidence of acute-onset diarrhea Complete protection from vomiting	—

Secondary

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

Countries

Japan

Contacts

Public ContactHiraku Fukushima

Hokkaido University Hospital Cancer Center

hirakuarata@gmail.com

Outcome results

None listed

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