Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07662200

A Simplified Regimen to Prevent Nausea and Vomiting Using Netupitant/Palonosetron in Germ Cell Cancer Patients Receiving Chemotherapy

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Germ Cell Cancer Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Ottawa Hospital Cancer Centre

Ottawa, Ontario, K1H 8L6, Canada

Location contact

Dominick Bossé, Medical Oncologist

CONTACT

[email protected]

1-613-737-7700 ext. 70166

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Netupitant/Palonosetron Hydrochloride

Drug

300mg/0.5mg combination pill taken once daily by mouth on the first and third day of chemotherapy

Ondansetron (Control)

Drug

8mg taken twice daily by mouth for 5 days

Aprepitant

Drug

Daily by mouth on the first (125mg), third (80mg), and fifth (80mg) day

Dexamethasone

Drug

Daily by mouth for 7 days (12mg on the first day, 8mg on subsequent days)

Olanzapine

Drug

5mg taken at night by mouth for 7 days

Primary outcomes

  1. Feasibility of study

    Time frame: Through study completion, up to 1 year

    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.

Secondary outcomes

  1. Complete Response (CR)

    Time frame: After Cycle 1 (Each cycle is 7 days)

    To evaluate the CR after Cycle 1

  2. Early Complete Response, late Complete Response and total control

    Time frame: 1 year

    To evaluate the response at the end of the study

  3. Review toxicities

    Time frame: 1 year

    Describe patient-reported toxicities using PRO-CTCAE

  4. Quality of Life outcomes

    Time frame: 1 year

    Describe the quality of life outcomes using the Functional Living Index Emesis (FLIE)

Study contacts

Contact information is provided by the study sponsor or research team.

Dominick Bossé, M.D.

CONTACT

[email protected]

1-613-737-7700 ext. 70166

Sponsors and collaborators

Lead sponsor

Ottawa Hospital Research Institute

Other

Registry information

Official study title

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

Acronym: SPARROW-GC

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Jun 23, 2026
Registry last updated
Jun 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.