A randomized phase III trial of palonosetron versus palonosetron plus dexamethasone (day1) for the prevention of nausea and vomiting induced by moderately emetogenic chemotherapy (HOPE-02)

A randomized phase III trial of palonosetron versus palonosetron plus dexamethasone (day1) for the prevention of nausea and vomiting induced by moderately emetogenic chemotherapy (HOPE-02) - A randomized phase III trial of PALO versus PALO plus DEX for the prevention of nausea and vomiting induced by MEC (HOPE-02)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000013249

Enrollment

320

Registered

2014-02-25

Start date

2014-04-01

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

Palonosetron 0.75mg/body Dexamethasone 9.9mg/body Palonosetron 0.75mg/body

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Age of 20 years or older 2.Diagnosis of malignancy 3.Prior chemotherapy with low or minimal emetogenicity, or no prior systemic chemotherapy 4.Moderately emetogenic chemotherapy is planned *Moderately emetogenic chemotherapy over 2 or more days is excluded * CDDP regimens are excluded regardless of its dosage *Also CBDCA regimens are excluded 5.Adequate bone marrow, liver and renal functions 6.ECOG performance status of 0-2 7.Written informed consent

Exclusion criteria

Exclusion criteria: 1)Serious or uncontrolled complication 2)Symptomatic or clinically suspected brain metastasis 3)Convulsive disorder requiring anti-convulsant 4)Ascites fluid or pleural effusion requiring paracentesis 5)Gastrointestinal obstruction 6)Vomiting and/or grade 1 or more nausea at baseline 7)Patients with planned radiotherapy 8)History of hypersensitivity to 5-HT3 receptor antagonist 9)History of hypersensitivity to dexamethasone 10) Continuous administration of steroids 11) Poorly controlled nausea by opioids 12)Pregnancy, lactation or who does not wish to contraception 13)History of palonosetorn administration 14)Without capability or intention of cooperating with study procedure 15)Participant in other anti-emetic trial 16)Undesirable for the patient to enter the trial

Design outcomes

Primary

Measure	Time frame
Complete response rate (overall period)	—

Secondary

Measure	Time frame
Complete response rate (acute, delayed phase) Complete control rate (overall period, acute, delayed phase) Total control rate (overall period, acute, delayed phase) No rescue medication rate Antiemetic agents-related adverse events Influence of steroids long-term use Change of antiemetic agents Transition of HbA1c *Adverse events (allergic reaction, nausea, vomiting, anorexia)	—

Countries

Japan

Contacts

Public ContactSatoshi Yuki

Hokkaido University Hospital Department of Gastroenterology

satoshi-yuuki175@joy.ocn.ne.jp011-706-5657

Outcome results

None listed

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