head and neck squamous cell carcinoma MedDRA version: 9.1 Level: HLT Classification code 10046311 Term: Upper respiratory tract neoplasms
Conditions
Interventions
Trade Name: PLATINEX*INFUS 25MG 50ML
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Cisplatin
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 25-
Sponsors
AZIENDA SANITARIA OSPEDALIERA "S. GIOVANNI BATTISTA DI TORINO"
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: istologically proven HNSCC age over 18 and under 75 PS ECOG 0-2 stage III - IV neoplasia unfit for surgery medical controindication for surgery 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: distant MTS previous chemotherapy and/or radiotherapy general condition that controindicate chemotheraphy or radiotherapy ischemic heart disease or heart failure in the last six months active infectious disease sensitive neuropathy grade to or more previous malignmant disease except cervical carcinoma, cutaneous basalioma or any other with more than five years follow up
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: toxicity locoregional control rate;Secondary Objective: disease free survival overall survival distant metastasis pattern predictive biological parameters;Primary end point(s): complete and parzial response rate toxicity | — |
Countries
Italy
Outcome results
None listed