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. 2021 Nov 16;2021(11):CD012775. doi: 10.1002/14651858.CD012775.pub2

UMIN000004863.

Methods Randomised, phase 3, active‐controlled study with 2 arms
  • comparison of aprepitant + granisetron + dexamethasone vs aprepitant + palonosetron + dexamethasone


Study period: May 2011 to June 2012
  • number of target subjects: 840


Masking: double‐blind
Baseline patient characteristics: n.r.
Participants Inclusion criteria
  • malignant tumour except for haematopoietic malignancy

  • ECOG performance status 0 to 2

  • 20 years old or over at the time of giving informed consent

  • receiving chemotherapy involving cisplatin as first line

  • dose of cisplatin 50 mg/m² over

  • regimens involving standard treatment for vomiting with dexamethasone, aprepitant, and 5‐HT₃ receptor antagonist

  • adequate organ function as defined by (each of the following values are examined within 8 days before entry):

  • AST ≤ 100 IU/L, ALT ≤ 100 IU/L

  • T‐Bill ≤ 2.0 mg/dL

  • CCr ≥ 60 mL/min

  • all subjects must be able to provide written informed consent before entry


Exclusion criteria
  • known prior severe hypersensitivity to 5‐HT₃ receptor antagonist, corticosteroids, and aprepitant

  • individuals who do not have enough whole body state for antineoplastic agent treatment

  • known symptomatic brain metastasis

  • convulsive disorder that needs anticonvulsant therapy

  • symptom of ascites or pleural effusion that needs puncture

  • obstruction of gastrointestinal tract, for example, gastric outlet or ileus, etc.

  • pregnant, breast‐feeding woman

  • enforced radiotherapy at bottom of diaphragm in the period between 6 days before and 6 days after date of first therapy

  • taking a medicine regularly, for example, 5‐HT₃ receptor antagonists, corticosteroids, antidopamine agonists, phenothiazine tranquilisers,antihistamine drugs, benzodiazepine agents, etc.

  • judged by investigator to be inappropriate for this study


Mean/median age, years: n.r.
Gender: male + female
Tumour/cancer type: solid malignancy (lung cancer, gastric cancer, oesophagus cancer, cervical cancer, endometrial cancer, head and neck cancer, etc.)
Chemotherapy regimen: cisplatin ≥ 50 mg/m²
Country: Japan
Interventions Experimental: arm A: granisetron
granisetron 1 mg + dexamethasone (Days 1 to 4) + aprepitant (Days 1 to 3)
Experimental: arm B: palonosetron
palonosetron 0.75 mg + dexamethasone (Days 1 to 4) + aprepitant (Days 1 to 3)
Outcomes Primary outcome
  • complete response rate of vomiting within 120 h from cisplatin administration


Secondary outcomes
  • complete control rate of events associated with vomiting within 120 h from cisplatin administration

  • total control rate of nausea and vomiting within 120 h from cisplatin administration

  • time to treatment failure (TTF)

  • adverse events

Notes
  • main ID: JPRN‐UMIN000004863

  • sponsor: Pharma Valley Center, Shizuoka Organization for Creation Industries