Induction Treatment in SCC of the Head and Neck Region - Concomitant Chemotherapy and Low-dose Radiotherapy

Prior treatment

• Prior treatment with any unauthorized medication or investigational treatment before the 5 half-lives of that substance or 4 weeks prior to study entry (a longer period of time should be assumed), or subjects currently enrolled to other interventional clinical trials.
• Concomitant malignancy or history of a malignancy with a significant potential impact to tolerability or effectivity of iCHRTL.
• Clinically significant heart disease including unstable angina, myocardial infarction within 6 months prior to study entry, severe congestive circulatory failure class New York Heart Association (NYHA) III-IV, arrhythmias unless it is treated, except for collateral contractions or minimal conduction disorders.
• Significant concomitant disease that cannot be treated, such as, but not limited to kidney, liver, gastrointestinal, endocrine system, respiratory, neurological and brain diseases and mental illnesses that may pose a risk to the patient in the opinion of the investigator.
• Women of childbearing potential, including women whose last menstrual period occurred in less than one year before screening, who cannot or do not want to use adequate contraception methods from the beginning of the study until 6 months after the last dose of study drug. Adequate contraception is defines as the use of oral hormonal contraceptives, an intrauterine device, a double barrier method or sexual abstinence.
• Men who cannot or do not want to use adequate contraception methods from the beginning of the study until 6 months after the last dose of study medication.

Other illness

• Subjects with known or suspected hypersensitivity to any of the study mediations.
• Chronic or active infection requiring antibiotic, antifungal or antiviral treatment, such as, but not limited to: chronic kidney infection, chronic respiratory tract infection with bronchospasm, tuberculosis or active hepatitis C virus infection.
• History of significant cerebrovascular disease within 6 months or currently symptomatic or its implications.
• Human Immunodeficiency Virus (HIV) infection.
• Active hepatitis B virus (HBV) infection, defined as having a positive Hepatitis B surface antigen (HBsAg) test. Moreover, in case of a negative HBsAg test result but a positive Hepatitis B core Antibody (HBcAb) test result (regardless of HBsAb status), HBV DNA should be determined and in case of a positive result the patient cannot be included to the study.
• Active hepatitis C virus (HCV) infection, defined as having a positive Hepatitis C Antibody (HCAb) test, in which case Hepatitis C virus recombinant immunoblot assay (HCV RIBA) should be determined from the same sample to confirm the result.

Lab values

• Baseline values for the following parameters (in the screening phase):
  • Creatinine \>2,0 x upper limit of normal (ULN) - unless creatinine clearance is normal
  • Total bilirubin \>1,5 x ULN (except for hyperbilirubinemia caused by Gilbert's syndrome)
  • Alanine Transaminase (ALT) activity, Aspartate Transaminase (ASPAT) \>2,5 x ULN
  • Alkaline phosphatase activity \>2,5 x ULN

Other

• Pregnancy or breastfeeding (women of childbearing potential must have pregnancy test performed during screening).
• Patients who cannot or do not want to adhere to the study Protocol.

• Patients with squamous cell carcinoma of oral cavity, upper, middle, lower pharynx carcinoma, larynx carcinoma or paranasal sinus carcinoma in advanced stage III or IV and previously not treated for this reason.
• Severity of the disease: N1 \> 2 cm, N2, N3 ; T2, T3, T4, M0
• Patient eligible for radical treatment with induction chemotherapy (at least in good general condition (ZUBROD 0-1) with no significant additional diseases disqualifying from induction chemotherapy).
• Written informed consent form to the proposed therapeutic scheme.
• Age over 18 years.