Head and neck cancer MedDRA version: 20.1 Level: HLT Classification code 10046311 Term: Upper respiratory tract neoplasms System Organ Class: 100000004855
Conditions
Interventions
Product Name: SANCUSO
Product Code: [IMP1]
Pharmaceutical Form: Transdermal patch
INN or Proposed INN: granisetron
CAS Number: 109889-09-0
Current Sponsor code: IMP1
Concentration unit: mg milligram(s
Sponsors
G.O.N.O. - GRUPPO ONCOLOGICO DEL NORD OVEST
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 •Rescue drugs employed (metoclopramide) •Safety (QTc change, assessment of grade 3-4 AEs) •Compliance with the study drug •QOL (MDASI-HN) •PRO-CTCAE library building in HNC pts •Pharmacokinetics in the first 10 pts enrolled in the coordinating Center •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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Italy
Contacts
Public ContactG.O.N.O.
G.O.N.O.
Outcome results
None listed