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 range18 Years
SexALL
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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
✕. 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.;