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Recruiting NCT07699276

Steroid Sparing Regimen With Olanzapine and Palonosetron for Emetic Prevention for High Dose Cisplatin

Phase II Interventional Cancer (Solid Tumors) Vomiting Cisplatin Olanzapine

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: dexamethasone sparing.
Who it may be relevant to
Registry conditions: Cancer (Solid Tumors), Vomiting, Cisplatin, Olanzapine. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Thailand
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Steroid-sparing Regimen With Olanzapine and Ondansetron to Prevent Emesis Caused by High Dose Cisplatin in Solid Cancer Patient : A Single Arm Phase II Study

Overview

A phase II study evaluating dexamethasone sparing regimen with olanzapine and palonosetron for patients receiving high dose cisplatin to prevent chemotherapy induced nausea and vomiting

Interventions

  • Drug dexamethasone sparing
    omit dexamethasone on day 2-4

Primary outcome measures

  • complete response rate [Time frame: 5 days after receiving chemotherapy]
Secondary outcome measures (4)
  • no -nausea rate [Time frame: 5 days after receiving chemotherapy]
  • degree of nausea vomiting [Time frame: 5 days after receiving chemotherapy]
  • adverse effects [Time frame: 5 days after receiving chemotherapy]
  • rescue therapy [Time frame: 5 days after chemotherapy]

Eligibility criteria

Inclusion criteria

  • histologically confirmed solid malignancy
  • scheduled for first cycle of cisplatin at dosage of at least 50 mg/m2

Exclusion criteria

  • pregnancy
  • pelvic or abdominal radiation within 4 weeks
  • uncontrolled brain metastasis
  • other moderate or high emetic risk chemotherapy on day 2-5
  • untreated gut obstruction
  • known allergy or severe adverse effect from palonosetron or olanzapine
  • AST/ ALT > 2.5x or serum creatinine clearance less than 50 ml/min

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Prevention

Study locations

Thailand · 1 center
  • Faculty of Medicine Siriraj Hospital, Mahidol University — Bangkok

Publications

  • Minatogawa H, Izawa N, Shimomura K, Arioka H, Iihara H, Sugawara M, Morita H, Mochizuki A, Nawata S, Mishima K, Tsuboya A, Miyaji T, Honda K, Yokomizo A, Hashimoto N, Yanagihara T, Endo J, Kawaguchi T, Furuya N, Sone Y, Inada Y, Ohno Y, Katada C, Hida N, Akiyama K, Ichikura D, Konomatsu A, Ogura T, Yamaguchi T, Nakajima TE. Dexamethasone-sparing on days 2-4 with combined palonosetron, neurokinin-1 PMID 37973958
  • Ithimakin S, Theeratrakul P, Laocharoenkiat A, Nimmannit A, Akewanlop C, Soparattanapaisarn N, Techawattanawanna S, Korphaisarn K, Danchaivijitr P. Randomized, double-blind, placebo-controlled study of aprepitant versus two dosages of olanzapine with ondansetron plus dexamethasone for prevention of chemotherapy-induced nausea and vomiting in patients receiving high-emetogenic chemotherapy. Support PMID 32128615
  • Celio L, Cortinovis D, Cogoni AA, Cavanna L, Martelli O, Carnio S, Collova E, Bertolini F, Petrelli F, Cassano A, Chiari R, Zanelli F, Pisconti S, Vittimberga I, Letizia A, Misino A, Gernone A, Bonizzoni E, Pilotto S, De Placido S, Bria E. Evaluating the impact of chemotherapy-induced nausea and vomiting on daily functioning in patients receiving dexamethasone-sparing antiemetic regimens with NEPA PMID 35999527
  • Celio L, Cortinovis D, Cogoni AA, Cavanna L, Martelli O, Carnio S, Collova E, Bertolini F, Petrelli F, Cassano A, Chiari R, Zanelli F, Pisconti S, Vittimberga I, Letizia A, Misino A, Gernone A, Bonizzoni E, Pilotto S, De Placido S, Bria E. Dexamethasone-Sparing Regimens with Oral Netupitant and Palonosetron for the Prevention of Emesis Caused by High-Dose Cisplatin: A Randomized Noninferiority Stu PMID 34101934

Identifiers

NCT: NCT07699276 · 330/2568(IRB4)

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗