GRANISETRON TRANSDERMAL SYSTEM (GTDS) IN PREVENTING NAUSEA AND VOMITING INDUCED BY CISPLATIN-BASED CHEMOTHERAPY AND CONCURRENT RADIOTHERAPY FOR HEAD AND NECK CANCER - Sancuso

G.O.N.O. - GRUPPO ONCOLOGICO DEL NORD OVEST0 个研究点目标入组 88 人开始时间: 2020年10月21日最近更新: 2020年12月7日

适应症

试验速览

暂无简介。

•1.Male and Females aged >= 18 years.
•2.Patients affected by head and neck cancer in one of the following subsites: oral cavity, oropharynx, hypopharynx, larynx, nasopharynx, paranasal sinus, salivary gland, skin of the head and neck, unknown primary in head and neck area
•3.Naïve to chemotherapy.
•4.Patients planned to receive 3 cycles of highly emetogenic treatments with cisplatin in single dose > 70 mg/m2 every 21 days concomitant to IMRT on head and neck
•5.Willing and able to understand and sign informed consent and complete the patient diary
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 50
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 38

•1.Scheduled to receive or having received in the past 4 weeks radiation treatment to brain, abdomen or pelvis.
•2.Brain metastasis
•3.Emesis or significant nausea within 24 hours before first chemotherapy cycle.
•4.Known ypersensitivity reaction to GTDS or any components of the product.
•5.Planne surgery procedures in the period of the study or within 2 weeks after the study conclusion.
•6.Historyof seizures or epilepsy.
•7.Active use of cannabinoids.
•8.Use of other investigational drugs within 30 days before study entry or during the study.
•9.Clinicaly significant findings on physical exam or presence of known clinically significant disease that would interfere with study evaluate.

发起方

G.O.N.O. - GRUPPO ONCOLOGICO DEL NORD OVEST