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Efficacy and safety of palonosetron and dexamethasone in patients who haven't responded to conventional antiemetic agents; granisetron and dexamethasone

Efficacy and safety of palonosetron and dexamethasone in patients who haven't responded to conventional antiemetic agents; granisetron and dexamethasone - Efficacy and safety of palonosetron and dexamethasone in patients who haven't responded to conventional antiemetic agents; granisetron and dexamethasone

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000009584
Enrollment
30
Registered
2012-12-19
Start date
2012-07-05
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

Day 1 Palonosetoron 0.75mg/body and dexamethasone 12mg/body should be administered 30 minutes prior to chemotherapy Day 2-3 Dexamethasone 4mg/body should be administered orally.

Sponsors

Gifu University graduate school of medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Pathologically colorectal cancer 2. Age; more than 20 years-old at registration 3. Performance status of 0-2 4. Patients receiving moderate emetic chemotherapy including oxaliplatin or irinotecan 5. Patients who has vomited(including dry-vomiting) or been administered additional rescue 6. Adequate organ function 7. Written informed consent

Exclusion criteria

Exclusion criteria: 1. Severe complication(s), e.g., congestive cardiac failure, coronary failure, cardiac infarction, angina pectoris, arrhythmia, cerebrovascular accident, active gastrointestinal tract ulcer, diabetes, renal failure, hepatic failure, active hepatitis or hepatic cirrhosis. 2. Symptomatic brain metastasis 3.Epilepsy patient treated with antiepileptic agent, exclusing being stable clinically 4.Combination radiotherapy 5. History of serious drug hypersensitivity for 5-HT3RA or dexamethasone. 6. History of administration of palonosetoron 7. Pregnant, nursing mothers or man who don't agree with contraception 8.Unsuitable patients judged by investigator

Design outcomes

Primary

MeasureTime frame
Complete Response rate

Countries

Japan

Contacts

Public ContactTakao Takahashi

Gifu University graduate school of medicine Department of surgical oncology

takaota@gifu-u.ac.jp058-230-6235

Outcome results

None listed

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