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Study of Aprepitant / Fosaprepitant for the Prevention of Chemotherapy-induced Nausea and Vomiting (CINV) in Colorectal Cancer Patients - SENRI Trial

ABSTRACT: The object of this study is to evaluate the superiority of aprepitant therapy with a 5HT3-receptor antagonist, dexamethasone and aprepitant compared to standard therapy with a 5HT3-receptor antagonist and dexamethasone for prevention of nausea and vomiting in first course chemotherapy.

DISEASE(S): Colorectal Cancer,Colorectal Neoplasms

PROVIDER: 2105952 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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Aprepitant Without Steroid in Preventing Chemotherapy-induced Nausea and Vomiting in Patients With Colorectal Cancer

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Randomized phase II study of aprepitant in patients with colorectal cancer receiving FOLFOX, FOLFIRI, or XELOX chemotherapy regimen.

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Project description:Interventions: Group A: * 1st course : Conventional therapy (Palonosetron 0.75 mg i.v. on 1st day + Dexamathasone 9.9 mg i.v. on 1st day, 8 mg p.o. on 2nd day and 3rd day) * 2nd course : Conventional therapy (Palonosetron 0.75 mg i.v. on 1st day + Dexamathasone 4.95 mg i.v. on 1st day, 4 mg p.o. on 2nd day and 3rd day) plus Aprepitant (125 mg p.o. on 1st day, 80 mg p.o. on 2nd day and 3rd day) Group B: * 1st course: Conventional therapy (Palonosetron 0.75 mg i.v. on 1st day + Dexamathasone 4.95 mg i.v. on 1st day, 4 mg p.o. on 2nd day and 3rd day) plus Aprepitant (125 mg p.o. on 1st day, 80 mg p.o. on 2nd day and 3rd day) * 2nd course : Conventional therapy (Palonosetron 0.75 mg i.v. on 1st day + Dexamathasone 9.9 mg i.v. on 1st day, 8 mg p.o. on 2nd day and 3rd day) Primary outcome(s): * Frequency of vomiting * Severity of nausea Study Design: Cross-over Randomized

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