Colorectal cancer or stomach cancer Colorectal cancer or stomach cancer
Conditions
Interventions
Patients will be randomly assigned in a 1:1 ratio
to either a group receiving two antiemetic agents (palonosetron hydrochloride and dexamethasone sodium phosphate) or a group receiving three antiemeti
Sponsors
Komatsu Yoshito
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients histologically diagnosed with colorectal cancer or gastric cancer who are scheduled to receive L-OHP or IRI as adjuvant chemotherapy after surgery, or as first-line treatment for unresectable, advanced, or recurrent disease. 2) Patients who have provided written informed consent of their own free will. 3) Patients aged 18 years or older at the time of consent acquisition. 4) Patients with adequate organ function (liver function, kidney function, bone marrow function). 5) Patients with an ECOG Performance Status (PS) of 0-2
Exclusion criteria
Exclusion criteria: 1) Patients with a history of chemotherapy. However, patients with a history of monotherapy with Tegafur/Gimeracil/Oteracil or Capecitabine alone are eligible for inclusion in this study. 2) Patients with symptomatic brain metastases or meningitis. 3) Patients with ascites or pleural effusion requiring paracentesis or thoracentesis. 4) Patients with gastrointestinal obstruction. 5) Patients who are pregnant or breastfeeding. Patients who wish to become pregnant or whose partner wishes to become pregnant during the study period. Patients unable to use highly effective contraception. 6) Patients with a history of radiation therapy at registration or scheduled to receive radiation therapy during the observation period. 7) Patients scheduled to receive Zolbetuximab in the first course. 8) Patients regularly taking opioid analgesics. 9) Patients who are regularly taking medications such as 5-HT3 receptor antagonists (5-HT3RAs) at the time of registration. 10) Patients who are already participating in another interventional trial or plan to participate in one during this trial. 11) Patients deemed unsuitable for this trial by the principal investigator or sub-investigator for other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete response (CR) to vomiting within 0-168 hours after initiation of chemotherapy | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Presence of CR at 0-24/24-120/120-168/0-120 hours/every 24 hours 2) Presence of Complete Control (CC) of nausea and vomiting at 0-168/0-24/24-120/120-168/0-120 hours/every 24 hours 3)Presence/Absence of Total Control (TC) of Nausea/Vomiting at 0-168/0-24/24-120/120-168/0-120 hours/every 24 hours 4) Time to Treatment Failure (TTF) 5) Time to First Vomiting Event 6) Time to First Antiemetic Rescue Therapy 7)Presence of vomiting events at 0-168/0-24/24-120/120-168/0-120 hours/every 24 hours 8)Presence of nausea at 0-168/0-24/24-120/120-168/0-120 hours and every 24 hours 9) Severity of nausea at 0-168/0-24/24-120/120-168/0-120 hours and every 24 hours (NRS: Numerical Rating Scale) 10)Presence of severe nausea at 0-168/0-24/24-120/120-168/0-120 hours and every 24 hours 11)0-168/0-24/24-120/120-168/0-120 hours/presence of antiemetic rescue therapy every 24 hours 12) QOL assessment (QLQ-C30) Safety Endpoints Adverse events (NCI-CTCAE ver. 6.0) Exploratory Endpoints Assessment of the association between risk factors (gender, age, alcohol consumption, history of motion sickness, history of hyperemesis gravidarum, smoking status, and cancer type) and the CR rate at 0-168 hours | — |
Contacts
Public ContactShuuichi Takasaki
Tonan Hospital
Outcome results
None listed