Carboplatin for Head and neck squamous cell carcinoma

Inclusion criteria

• {"criterion_text":"- Patients with advanced squamous cell carcinoma of the oral cavity, pharynx, larynx or paranasal sinuses\n- Severity of the disease: N1> 2 cm, N2, N3; T2, T3, T4, M0\n- Patient eligible for radical treatment with induction chemotherapy (general condition at least good, no significant additional conditions disqualifying from induction chemotherapy)\n- Signed informed consent to participate in the study\n- ≥ 18 years of age"}

Exclusion criteria

• {"criterion_text":"- Known or suspected hypersensitivity to any of the investigational drugs\n- Hepatitis B virus (HBV) infection defined as a positive test for HBsAg. In addition, in the case of a negative HBsAg test result, but a positive HBcAb test result (regardless of HBsAb status), HBV DNA testing should be performed and in the case of a positive result, the patient cannot be included in the trial\n- Hepatitis C virus (HCV) infection defined as a positive HCAb test, in which case an HCV RIBA immunoblot test from the same sample should be performed to confirm the result\n- Pregnancy or breastfeeding (women of childbearing age should undergo a pregnancy test at screening)\n- Women of childbearing potential, including those with their last menstrual period less than one year prior to screening, who are unable or unwilling to use adequate contraception methods from the beginning of the study to seven months after the last intake dose of the study drug.\n- Men who are unable or unwilling to use adequate contraceptive methods from the start of the study to six months after taking the last dose of study medication\n- Patients unable or unwilling to adhere to the study protocol.\n- Baseline values for the following parameters (during the screening phase): -Creatinine> 2.0 times upper limit of normal (unless creatinine clearance is normal); - Total bilirubin> 1.5 times the upper limit of normal (except for hyperbilirubinemia due to Gilbert's syndrome); - ALT > 2.5 times the upper limit of normal; - Alkaline phosphatase activity> 2.5 times the upper limit of normal\n- First treatment with any unauthorized drug or experimental treatment within 5 half-lives of this substance or 4 weeks prior to enrollment in a study (longer period must be taken), or currently enrollment in other interventional clinical trials\n- Coexistence of another neoplasm or a history of neoplastic disease with a significant potential influence on the tolerability or efficacy of iCHRTL\n- Chronic or active infection requiring the use of antibiotics, antifungal medications, or antiviral medications, such as, but not limited to, chronic kidney infection, chronic bronchospastic respiratory infection, tuberculosis, or active hepatitis C\n- Significant history of cerebrovascular disease within 6 months or current symptomatic or sequelae\n- HIV infection\n- Clinically significant heart disease including unstable angina, myocardial infarction in the 6 months prior to study entry, severe NYHA III-IV congestive heart failure, arrhythmias, unless treatable, except for extrasystole or minimal contractions conduction disturbances\n- Significant co-morbidities that are untreatable, such as, but not limited to, kidney, liver, gastrointestinal, endocrine, respiratory, neurological, brain, and mental illness that the investigator believes may pose a risk to the patient"}

Primary endpoints

• {"endpoint_text":"- Objective response rate after induction assessment (ORR)\n- Local and nodal healing rate assessement (LRC)\n- Assessment of the frequency of individual adverse events\n- Progression-free survival assessment (PFS)\n- Overall survival assessment (OS)","definition_or_measurement_approach":"- ORR: after induction assessment\n- LRC: assessment of local and nodal healing rate\n- Assessment of the frequency of individual adverse events: evaluation of individual adverse event frequency\n- PFS: progression-free survival assessment\n- OS: overall survival assessment"}

Secondary endpoints

• {"endpoint_text":"- Distant metastases rate assessment\n- Evaluation of the molecular and biochemical (immunological) effect of low doses of ionizing radiation\n- Relapse free survival (RFS) assessment","definition_or_measurement_approach":"- Distant metastases rate assessment: assessment of rate of distant metastases\n- Evaluation of the molecular and biochemical (immunological) effect of low doses of ionizing radiation: evaluation of molecular/biochemical (immunological) effects\n- Relapse free survival (RFS) assessment: assessment of relapse-free survival"}

Poland

Earliest CTIS Part Ii Submission Date

22-10-2024

Latest Decision Or Authorization Date

27-03-2026

Processing Time Days

521

Number Of Sites

1

Number Of Participants

40

Primary sponsor

Full Name

Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Poland