CISPLATIN for HPV-positive oropharyngeal squamous cell carcinoma

Inclusion criteria

• {"criterion_text":"- Oropharyngeal squamous cell carcinoma\n- Positivity of p16 by imunohistochemistry\n- Clinical stage T1-T2, N1-N2c or T3, N2-N2c, UICC 8th edition without distant metastases\n- The lifetime cumulative history of smoking cannot exceed 20 packages / years\n- WHO status 0-1\n- Age ≥ 18 years\n- Both genders\n- Hemoglobin ≥ 10 g/l\n- Platelets ≥1 00x 10x9/l\n- Neutrophils ≥ 1,5 x 10x9/l\n- Adequate renal functions enable one-week therapy of cisplatina\n- Bilirubin, AST or ALT 3x upper limit of norm\n- Negative pregnancy test\n- Signed informed consent\n- Slovak language"}

Exclusion criteria

• {"criterion_text":"- Tumor in the oral cavity or in nasopharynx or in the hypopharynx or larynx if the p16 is also positive\n- Tumor of unknown origin (p16 positivity too)\n- Simultaneous tumors\n- Patients with invasive malignancy (except non-melanoma skin cancer) and a history of tumor diagnosis less than 3 years\n- Previous radiotherapy in the head and neck area to overlap the irradiated volume\n- Unstable angina or congestive heart failure requiring hospitalization for the last 6 months\n- Transmural myocardial infarction last 6 months\n- Active infection requiring i.v. antibiotics at the time of registration\n- Chronic obstructive bronchoplumonal disease with exacerbation or other respiratory disease requiring hospitalization or postponement of study treatment within 30 days of enrollment\n- Hepatic insufficiency with clinical jaundice and impaired coagulation\n- Active AIDS disease, but the protocol does not require HIV testing\n- Pregnancy\n- Previous allergic reaction to cisplatin"}

Primary endpoints

• {"endpoint_text":"- Two-year locoregional control","definition_or_measurement_approach":"Primary objective refers to assessment of two-year local (locoregional) disease control; no further measurement details provided in Part I other than the main objective mentioning two-year local disease control."}

Secondary endpoints

• {"endpoint_text":"- Primary loco-regional control after initial intervention and CRT\n- Overall survival\n- Disease-specific survival\n- Survival without disease\n- Percentage of distant metastases\n- Adverse effects\n- Influencing QoL\n- Reliability and validity of biomarker p16\n- Difference in OPC-associated HPV molecular profile in non-smokers and smokers","definition_or_measurement_approach":"Secondary objectives include assessment of relapse-free and overall survival, acute toxicity and compliance, PROs using validated questionnaires (quality of life and impact on sexual life), central assessment of p16 and correlation with HPV tests, molecular/genomic tumour profiling, and PET-CT negative predictive value; specific measurement methods are referenced in secondary objectives but detailed measurement schedules are not provided in Part I."}

Slovakia

Earliest CTIS Part Ii Submission Date

26-10-2024

Latest Decision Or Authorization Date

04-11-2024

Processing Time Days

9

Number Of Sites

1

Number Of Participants

100

Primary sponsor

Full Name

Vychodoslovensky Onkologicky Ustav a.s.

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Slovakia

Third parties

• {"country":"Slovakia","full_name":"Univerzita Pavla Jozefa Safarika V Kosiciach","duties_or_roles":"code:1","organisation_type":"Educational Institution"}