Dexamethasone-sparing Approach Including NEPA Against Emesis Caused by Cisplatin
NCT ID: NCT04201769
Last Updated: 2020-04-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
261 participants
INTERVENTIONAL
2016-11-25
2020-04-30
Brief Summary
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Detailed Description
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For the prevention of delayed CINV, patients will be assigned randomly to one of the following treatment arms:
* Test arm A: no further anti-emetic prophylaxis on days 2 thorough 4;
* Test arm B: oral dexamethasone 4 mg once per day in the morning of days 2 and 3;
* Reference arm C: oral dexamethasone 4 mg twice per day on days 2 thorough 4.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Arm A
Oral Netupitant/Palonosetron (NEPA) and intravenous Dexamethasone (DEX) on Day 1 of chemotherapy.
No further anti-emetic prophylaxis on days 2 thorough 4.
Netupitant/Palonosetron
NEPA is adiministered 60 minutes before chemotherapy, on day 1
Dexamethasone
Intravenous dexamethasone 12 mg is administered 30 minutes before chemotherapy initiation, on day 1.
The administration of DEX in the subsequent days (2-4) depends on the randomly assignement to treatment arm
Arm B
Oral Netupitant/Palonosetron (NEPA) and intravenous Dexamethasone (DEX) on Day 1 of chemotherapy.
Oral dexamethasone 4 mg once per day in the morning of days 2 and 3.
Netupitant/Palonosetron
NEPA is adiministered 60 minutes before chemotherapy, on day 1
Dexamethasone
Intravenous dexamethasone 12 mg is administered 30 minutes before chemotherapy initiation, on day 1.
The administration of DEX in the subsequent days (2-4) depends on the randomly assignement to treatment arm
Arm C
Oral Netupitant/Palonosetron (NEPA) and intravenous Dexamethasone (DEX) on Day 1 of chemotherapy.
Oral dexamethasone 4 mg twice per day on days 2 thorough 4.
Netupitant/Palonosetron
NEPA is adiministered 60 minutes before chemotherapy, on day 1
Dexamethasone
Intravenous dexamethasone 12 mg is administered 30 minutes before chemotherapy initiation, on day 1.
The administration of DEX in the subsequent days (2-4) depends on the randomly assignement to treatment arm
Interventions
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Netupitant/Palonosetron
NEPA is adiministered 60 minutes before chemotherapy, on day 1
Dexamethasone
Intravenous dexamethasone 12 mg is administered 30 minutes before chemotherapy initiation, on day 1.
The administration of DEX in the subsequent days (2-4) depends on the randomly assignement to treatment arm
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Histologically or cytologically confirmed diagnosis of NSCLC
* Patients naїve to cisplatin-containing chemotherapy as well as any prior chemotherapy containing either highly or moderately emetogenic agents given for NSCLC or other malignancy.
* Patients scheduled to receive their first cycle of cisplatin-based chemotherapy at a dose ≥70 mg/m2 either alone or in combination with other agents of low or minimal potential of emetogenicity (i.e., pemetrexed, gemcitabine±bevacizumab, vinorelbine) as neo-adjuvant, adjuvant or palliative therapy. Patients with progressive disease on therapy with an EGFR-TKI (Epidermal Growth Factor Receptor-Tyrosine Kinase Inhibitors) and scheduled to receive cisplatin-based chemotherapy will be eligible for the study.
* ECOG (Eastern Cooperative Oncology Group) Performance Status of 0-1.
* Body Mass Index ≥18.5.
* Written informed consent before study entry.
* If women of childbearing potential age: effective contraceptive measures must be used during all the planned course of chemotherapy and up to 30 days after last NEPA administration.
* Normal hepatic function (≤2 times the upper limit of normal for liver transaminases) and renal function (creatinine ≤ 1.5 times the upper limit of normal).
* Ability and willingness of the patient to complete the diary and study questionnaires.
* Psychiatric or CNS (Central Nervous System) disorders interfering with ability to comply with study protocol.
Exclusion Criteria
* Patients scheduled to receive radiation therapy to the abdomen or pelvis within 1 week before day 1 or between day 1 and 5 following the first cycle of chemotherapy.
* Patients scheduled to receive concurrent chemo/radiotherapy for NSCLC.
* Treatment with investigational medications within 30 days before the study medication.
* Myocardial infarction within the last 6 months.
* Documented or known hypersensitivity to 5HT3RA (5-Hydroxytryptamine Receptor 3 Antagonists) or NK-1RA (Neurokinin-1 Receptor Antagonist) and excipients (see section 6.1 of Akynzeo SPC).
* Uncontrolled diabetes mellitus or active infection.
* Nausea and vomiting in the 24 hours before study treatment.
* Chronic use of systemic corticosteroids (except for topical and inhaled corticosteroids) or any other agent with anti-emetic potential. Patients receiving dexamethasone on the day before chemotherapy for prevention of the pemetrexed-induced skin rash will be eligible for the study.
* Patient's inability to take oral medication.
* Gastrointestinal obstruction or active peptic ulcer.
* Pregnancy or breast feeding.
18 Years
ALL
No
Sponsors
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Consorzio Oncotech
OTHER
Responsible Party
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Principal Investigators
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Emilio Bria, MD
Role: STUDY_CHAIR
Fondazione Policlinico Universitario "A. Gemelli" IRCCS, UCSC - Rome (Italy)
Luigi Celio, MD
Role: STUDY_DIRECTOR
Fondazione IRCCS "Istituto Nazionale Tumori" - Milan (Italy)
Locations
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ASST Bergamo Ovest - Ospedale di Teviglio
Treviglio, BG, Italy
Azienda ULSS 1 Dolomiti - Ospedale Santa Maria del Prato
Feltre, BL, Italy
ASST Ovest Milanese - Ospedale di Legnano
Legnano, MI, Italy
AOU San Luigi Gonzaga
Orbassano, TO, Italy
A.O.U. Consorziale Policlinico di Bari
Bari, , Italy
IRCCS Istituto Tumori "Giovanni Paolo II"
Bari, , Italy
ASST Spedali Civili di Brescia
Brescia, , Italy
Azienda Ospedaliera Cosenza
Cosenza, , Italy
ASST Lecco - P.O. "A. Manzoni"
Lecco, , Italy
A.O.U. Policlinico di Modena
Modena, , Italy
Ospedale San Gerardo - ASST Monza
Monza, , Italy
A.O.R.N. dei Colli - Ospedale Monaldi
Napoli, , Italy
Casa di Cura di Alta Specialità Dip. Oncologico di III livello "La Maddalena"
Palermo, , Italy
Ospedale S. Maria della Misericordia
Perugia, , Italy
Ospedale di Piacenza
Piacenza, , Italy
IRCCS Arcispedale S. Maria Nuova
Reggio Emilia, , Italy
A.O. San Camillo Forlanini
Roma, , Italy
A.O. San Giovanni - Addolorata
Roma, , Italy
Fondazione Policlinico "A. Gemelli" - Università Cattolica Sacro Cuore
Roma, , Italy
Istituto Nazionale Tumori "Regina Elena"
Roma, , Italy
Policlinico Tor Vergata
Roma, , Italy
Ospedale Civile SS. Annunziata
Sassari, , Italy
Ospedale Umberto I - RAO SR
Syracuse, , Italy
P.O. "San Giuseppe Moscati"
Taranto, , Italy
Azienda ULSS 2 Marca Trevigiana - Ospedale di Treviso
Treviso, , Italy
A.O.U.I. Verona - Policlinico "G.B. Rossi"
Verona, , Italy
Countries
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References
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Celio L, Aapro M. Characteristics of nausea and its impact on health-related quality of life in cisplatin-treated patients receiving dexamethasone-sparing prophylaxis: an analysis of the LUNG-NEPA study. Support Care Cancer. 2024 Mar 4;32(3):204. doi: 10.1007/s00520-024-08406-5.
Celio L, Bartsch R, Aapro M. Dexamethasone-sparing regimens with NEPA (netupitant/palonosetron) for the prevention of chemotherapy-induced nausea and vomiting in older patients (>65 years) fit for cisplatin: A sub-analysis from a phase 3 study. J Geriatr Oncol. 2023 Jul;14(6):101537. doi: 10.1016/j.jgo.2023.101537. Epub 2023 Jun 7.
Celio L, Cortinovis D, Cogoni AA, Cavanna L, Martelli O, Carnio S, Collova E, Bertolini F, Petrelli F, Cassano A, Chiari R, Zanelli F, Pisconti S, Vittimberga I, Letizia A, Misino A, Gernone A, Bonizzoni E, Pilotto S, De Placido S, Bria E. Exploratory analysis of the effect of a dexamethasone-sparing regimen for prophylaxis of cisplatin-induced emesis on food intake (LUNG-NEPA study). Sci Rep. 2023 Jan 23;13(1):1257. doi: 10.1038/s41598-023-28464-9.
Celio L, Cortinovis D, Cogoni AA, Cavanna L, Martelli O, Carnio S, Collova E, Bertolini F, Petrelli F, Cassano A, Chiari R, Zanelli F, Pisconti S, Vittimberga I, Letizia A, Misino A, Gernone A, Bonizzoni E, Pilotto S, De Placido S, Bria E. Evaluating the impact of chemotherapy-induced nausea and vomiting on daily functioning in patients receiving dexamethasone-sparing antiemetic regimens with NEPA (netupitant/palonosetron) in the cisplatin setting: results from a randomized phase 3 study. BMC Cancer. 2022 Aug 24;22(1):915. doi: 10.1186/s12885-022-10018-3.
Other Identifiers
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LUNG-NEPA
Identifier Type: -
Identifier Source: org_study_id
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