A Cohort Study on the Prevention of Nausea and Vomiting Induced by Concurrent Chemoradiotherapy f… (NCT07442890) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
A Cohort Study on the Prevention of Nausea and Vomiting Induced by Concurrent Chemoradiotherapy for Lung Cancer Using Rolapitant and Palonosetron
238 participantsStarted 2026-04-30
Plain-language summary
This study aims to evaluate the efficacy and safety of a combination regimen based on Rolapitant Palonosetron injection for preventing nausea and vomiting induced by concurrent chemoradiotherapy in lung cancer patients. It will also analyze the differences in preventive efficacy between two combination regimens, filling the gap in antiemetic data for radiotherapy combined with moderately to highly emetogenic chemotherapy. This research will provide evidence for optimizing antiemetic strategies in patients undergoing concurrent chemoradiotherapy.
Who can participate
Age range
18 Years
Sex
ALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Age ≥18 years, no gender restrictions;
. Histopathologically or cytologically confirmed lung cancer;
. Planned to receive concurrent chemoradiotherapy for at least 6 weeks, with radiotherapy administered in conventional fractions (2.0-2.2 Gy/fraction, 5 fractions/week, total dose 60-66 Gy); chemotherapy regimen includes highly emetogenic agents (e.g., cisplatin ≥60 mg/m²) ;
. ECOG Performance Status score: 0-1;
. Expected survival \>12 weeks;
. Adequate organ and bone marrow function;
. Willingness to complete daily nausea/vomiting logs and scale assessments.
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. Patients with imaging-confirmed brain metastases accompanied by symptoms of increased intracranial pressure (e.g., headache, vomiting, papilledema) or objective evidence of elevated intracranial pressure.
. Patients with a documented history of severe hypersensitivity to the active ingredient or excipients of the drug.
. Known contraindications to NK-1 receptor antagonists, 5-HT3 receptor antagonists, dexamethasone, or olanzapine;
. Vomiting symptoms (≥1 episode/day) or VAS score ≥30 mm within 7 days prior to first administration;
. Use of medications with potential antiemetic effects within 2 days prior to first dose: first-generation 5-HT3 receptor antagonists (e.g., ondansetron), phenothiazines (e.g., prochlorperazine), butyrophenones (e.g., haloperidol), benzamides (e.g., metoclopramide), domperidone, cannabinoids, traditional Chinese medicines with potential antiemetic effects, scopolamine, secloperazine, etc.;
. Presence of conditions affecting vomiting assessment, such as gastrointestinal obstruction, gastroparesis, or intestinal obstruction;
. History of epilepsy or current use of antiepileptic drugs;