Human Papillomavirus oropharyngeal squamous cell carcinoma MedDRA version: 20.0 Level: SOC Classification code 10029104 Term: Neoplasms benign, malignant and unspecified (incl cysts and polyps) System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: CISPLATIN EBEWE
Product Name: cisplatina
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: CISPLATINA
CAS Number: 15663-27-1
Other descriptive name: cispla
Sponsors
VÝCHODOSLOVENSKÝ ONKOLOGICKÝ ÚSTAV, a.s.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Oropharyngeal squamous cell carcinoma • Positivity of p16 by imunohistochemistry • Clinical stage T1-T2, N1-N2c or T3, N2-N2c, UICC 8th edition without distant metastases • The lifetime cumulative history of smoking cannot exceed 20 packages / years • WHO status 0-1 • Age = 18 years • Both genders • Hemoglobin = 10 g/l • Platelets =1 00x 10x9/l • Neutrophils = 1,5 x 10x9/l • Adequate renal functions enable one-week therapy of cisplatina • Bilirubin, AST or ALT 3x upper limit of norm • Negative pregnancy test • Signed informed consent • Slovak language 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 120 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Tumor in the oral cavity or in nasopharynx or in the hypopharynx or larynx if the p16 is also positive • Tumor of unknown origin (p16 positivity too) • Simultaneous tumors • Patients with invasive malignancy (except non-melanoma skin cancer) and a history of tumor diagnosis less than 3 years • Previous radiotherapy in the head and neck area to overlap the irradiated volume • Unstable angina or congestive heart failure requiring hospitalization for the last 6 months • Transmural myocardial infarction last 6 months • Active infection requiring i.v. antibiotics at the time of registration • Chronic obstructive bronchoplumonal disease with exacerbation or other respiratory disease requiring hospitalization or postponement of study treatment within 30 days of enrollment • Hepatic insufficiency with clinical jaundice and impaired coagulation • Active AIDS disease, but the protocol does not require HIV testing • Pregnancy • Previous allergic reaction to cisplatin
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Assesment of primary CRT de-escalation effectiveness in achieving two-year local disease control and late toxicity prevalence evaluated by CTC AE v.4 and PRO CTC v 4.;Secondary Objective: Assessment of relapse-free and overall survival, Assessment of acute toxicity and compliance with treatment, Analysis of results according to known prognostic factors including smoking, Assesment of PRO in terms of quality of life before and after treatment using validated questionnaires, Assesment of the impact of treatment on sexual life using a validated questionnaire, Standardization of RT OPC planning in participating centers, Dosimetric risk analysis of xerostomy and dysphagia, Central assessment of p16 status and its correlation with a specific test aimed at identifying HPV oncogenes, Molecular profile and genomic analysis of tumors in non-smokers and smokers, Assessment of negative predictive value of PETCT after CRT. ;Primary end point(s): Two-year locoregional control;Timepoint(s) of evaluation of this end point: 2 years | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Primary loco-regional control after initial intervention and CRT Overall survival Disease-specific survival Survival without disease Percentage of distant metastases Adverse effects Influencing QoL Reliability and validity of biomarker p16 Difference in OPC-associated HPV molecular profile in non-smokers and smokers ;Timepoint(s) of evaluation of this end point: 2 years | — |
Countries
Slovakia
Contacts
Public ContactOddelenia radiacnej onkológie
VÝCHODOSLOVENSKÝ ONKOLOGICKÝ ÚSTAV, a.s.
Outcome results
None listed