A Simplified Regimen to Prevent Nausea and Vomiting Using Netupitant/Palonosetron in Germ Cell Cancer Patients Receiving Chemotherapy (SPARROW-GC)

A Pilot Feasibility Study of a Steroid-Sparing Anti-Nausea and Vomiting Regimen With Netupitant/Palonosetron for Patients With Germ Cell Tumours Receiving Multi-Day Cisplatin-Based Chemotherapy at The Ottawa Hospital

This is a single-site, open-label, randomized pilot feasibility study conducted at The Ottawa Hospital Cancer Centre. A total of 10 participants will be randomized 1:1 to either the experimental or control arm.

The purpose of this study is to evaluate recruitment capability, intervention adherence, data completeness, and safety prior to consideration of a potential future multi-centre randomized trial.

Study Overview

• Status: Not yet recruiting
• Conditions: Germ Cell Cancer
• Intervention / Treatment: Drug: Ondansetron (Control); Drug: Aprepitant; Drug: Dexamethasone; Drug: Olanzapine; Drug: Netupitant/Palonosetron Hydrochloride

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Dominick Bossé, M.D.; Phone Number: 70166 1-613-737-7700; Email: dbosse@toh.ca

Study Locations

• Canada
  • Ontario
    • Ottawa, Ontario, Canada, K1H 8L6
      • Ottawa Hospital Cancer Centre
      • Contact: Dominick Bossé, Medical Oncologist; Phone Number: 70166 1-613-737-7700; Email: dbosse@toh.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

1. Diagnosis of germ cell cancer
2. Indication for outpatient treatment using a standard 5-day cisplatin-based chemotherapy regimen

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group 1; Ondansetron 8mg taken twice daily by mouth for 5 days; Aprepitant taken daily by mouth on the first (125mg), third (80mg), and fifth (80mg) day.; Dexamethasone taken daily by mouth for 7 days (12mg on the first day, 8mg on subsequent days); Olanzapine 5mg taken at night by mouth for 7 days	Drug: Ondansetron (Control); 8mg taken twice daily by mouth for 5 days; Drug: Aprepitant; Daily by mouth on the first (125mg), third (80mg), and fifth (80mg) day; Drug: Dexamethasone; Daily by mouth for 7 days (12mg on the first day, 8mg on subsequent days); Drug: Olanzapine; 5mg taken at night by mouth for 7 days
Experimental: Group 2; Netupitant/Palonosetron* (300mg/0.5mg) combination pill taken once daily by mouth on the first and third day of chemotherapy; Dexamethasone 4mg taken once daily by mouth for 5 days; Olanzapine 5mg taken at night by mouth for 7 days	Drug: Dexamethasone; Daily by mouth for 7 days (12mg on the first day, 8mg on subsequent days); Drug: Olanzapine; 5mg taken at night by mouth for 7 days; Drug: Netupitant/Palonosetron Hydrochloride; 300mg/0.5mg combination pill taken once daily by mouth on the first and third day of chemotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of study	To measure the feasibility of the study, the researchers will collect the recruitment rate, the consent rate among eligible patients, the completion of symptom and quality-of-life assessments, the adherence to protocol, the frequency of protocol deviations and safety events.	Through study completion, up to 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complete Response (CR)	To evaluate the CR after Cycle 1	After Cycle 1 (Each cycle is 7 days)
Early Complete Response, late Complete Response and total control	To evaluate the response at the end of the study	1 year
Review toxicities	Describe patient-reported toxicities using PRO-CTCAE	1 year
Quality of Life outcomes	Describe the quality of life outcomes using the Functional Living Index Emesis (FLIE)	1 year

Collaborators and Investigators

• Sponsor: Ottawa Hospital Research Institute

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2028

Study Registration Dates

• First Submitted: May 21, 2026
• First Submitted That Met QC Criteria: June 18, 2026
• First Posted (Actual): June 23, 2026

Study Record Updates

• Last Update Posted (Actual): June 23, 2026
• Last Update Submitted That Met QC Criteria: June 18, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Palonosetron; Netupitant; SPARROW-GC; Steroid-Sparing Anti-Nausea and Vomiting Regimen
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Neoplasms, Germ Cell and Embryonal; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Azoles; Polycyclic Compounds; Imidazoles; Indoles; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Steroids, Fluorinated; Pregnadienetriols; Benzazepines; Morpholines; Oxazines; Heterocyclic Compounds, Bridged-Ring; Benzodiazepines; Heterocyclic Compounds, 3-Ring; Carbazoles; Isoquinolines; Quinuclidines; Olanzapine; Palonosetron; Aprepitant; Dexamethasone; Ondansetron; netupitant
• Other Study ID Numbers: OHRI SPARROW-GC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No