The clinical trial concerns the use of an innovative \"anti-emetic\" drug (that is, anti-vomiting and nausea) in subjects affected by endometrial cancer. It is addressed to patients who have never received chemotherapy before and are about to start a treatment with platinum and taxanes with or without immunotherapy for endometrial cancer.
The primary objective of the study is to learn if the drug is able to avoid the occurrence of vomiting and post- nausea chemotherapy within 120 hours after cycle 1 with carboplatin and paclitaxel with or without immunotherapy.
Partecipants will take the drug before the chemotherapy/immunotherapy (single dose at day one of each cycle of therapy, that is one capsule before treatment). The entire duration of participation in the study may extend to the fourth cycle of chemotherapy/immunotherapy.
Patients will fill in questionnaires and keep a diary of the number and intensity of symptoms (vomiting and nausea).
Subject is at least 18 years of age, able to understand the study procedures, and agrees to participate in the study by providing written informed consent
Subject has histologically or cytologically proven endometrial cancer
Patients were required to have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
Adequate organ function allowing the patient to receive taxane-platinum combination therapy with or without immunotherapy according to clinical practice and opinion of treating physician
They will experience emesis within the 24 hours before receipt of 1 course of chemotherapy
will be scheduled to radiation therapy to the abdomen or pelvis within 1 week before day 1 or between day 1 and 5
Will be scheduled to undergo bone marrow or stem-cell transplant
Chronic systemic corticosteroid use
Single group
NEPA (300mg netupitant/0.5mg palonosetron)
Druga single dose (capsule) of NEPA (300mg netupitant/0.5 palonosetron) at day 1 for a maximum of 4 cycles
Effectiveness
Evaluate effectiveness of a single oral dose of NEPA in terms of complete response (CR: no emesis, no rescue medication) in the overall phase (0-120h) at cycle 1 in chemotherapy-naïve patients with endometrial cancer receiving paclitaxel and carboplatin chemotherapy with or without immunotherapy
Effectiveness
Effectiveness of a single oral dose of NEPA in terms of CR and complete control (CC: no rescue medication, no emesis and no nausea (VAS score of \<25 mm) during the acute (0-24 hours), delayed (\>24 to 120 hours), and overall (0-120 hours) phases after the start of chemotherapy of each cycle
Effectiveness
Effectiveness of a single dose of NEPA in terms of no rescue medication, no emesis and no significant nausea (VAS score of \<25 mm) during the acute (0-24 hours), delayed (\>24 to 120 hours), and overall (0-120 hours) after the start of chemotherapy of each cycle
Effectiveness
Effectiveness of a single oral dose of NEPA in terms of CR and complete control during the acute (0-24 hours), delayed (\>24 to 120 hours), and overall (0-120 hours) phases after the start of each cycle according to Patient Emetogenicity Risk Profile assessed with CINV Risk Assessment tool
Safety
Evaluate safety of NEPA when given in multiple treatment cycles in patients with endometrial cancer receiving paclitaxel and carboplatin regimen with or without immunotherapy
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