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

Phase 1

• Conditions: Head and neck cancer; MedDRA version: 20.1Level: HLTClassification code 10046311Term: Upper respiratory tract neoplasmsSystem Organ Class: 100000004855; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2018-003669-32-IT
• Lead Sponsor: G.O.N.O. - GRUPPO ONCOLOGICO DEL NORD OVEST

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-10-21
• Last Update Posted: 7 December 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 88

Inclusion Criteria

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

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: •Complete control [no vomiting, no rescue treatment, and no signi¿cant nausea (VAS<25mm)] along the period of chemoradiation 4th week - 1 week after RT end (5 weeks altogether);Secondary Objective: •Incidence of nausea and vomiting<br>•Rescue drugs employed (metoclopramide)<br>•Safety (QTc change, assessment of grade 3-4 AEs)<br>•Compliance with the study drug<br>•QOL (MDASI-HN)<br>•PRO-CTCAE library building in HNC pts<br>•Pharmacokinetics in the first 10 pts enrolled in the coordinating Center <br>•Correlation of mean radiation dose to vomiting center structures with incidence of nausea and vomiting;Primary end point(s): •Complete control [no vomiting, no rescue treatment, and no signi¿cant nausea (VAS<25 mm)] along the period of chemoradiation 4th week - 1 week after RT end (5 weeks altogether);Timepoint(s) of evaluation of this end point: 1 week after the end of radiotherapy

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): •Incidence of nausea and vomiting; •Safety (QTc change, grade 3 adverse events); Quality of live (QOL MDASI-HN);Timepoint(s) of evaluation of this end point: during 5 weeks of treatment; during the 5 weeks of treatment up to 1 week after the completion of radiotherapy; during the 5 weeks of treatment up to 1 week after the completion of radiotherapy