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Induction treatment of patients with head and neck squamous cell carcinoma using simultaneous chemotherapy and low-dose radiotherapy (iCHRTL)
EU CTIS ID: 2024-517480-23-00
What this study is testing
- Evaluation of the efficacy of iCHRTL in patients with advanced squamous cell carcinoma of the oral cavity, pharynx, larynx or paranasal sinuses - Assessment of iCHRTL tolerance in patients with advanced squamosus cell carcinoma of the oral cavity, pharynx, larynx or paranasal sinuses - Evaluation of the molecular and biochemical (immunological) effect of low doses of ionizing radiation
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Patients with advanced squamous cell carcinoma of the oral cavity, pharynx, larynx or paranasal sinuses
- Severity of the disease: N1> 2 cm, N2, N3; T2, T3, T4, M0
- Patient eligible for radical treatment with induction chemotherapy (general condition at least good, no significant additional conditions disqualifying from induction chemotherapy)
- Signed informed consent to participate in the study
- ≥ 18 years of age
You likely can't join if
- Known or suspected hypersensitivity to any of the investigational drugs
- 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
- 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
- Pregnancy or breastfeeding (women of childbearing age should undergo a pregnancy test at screening)
- 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.
- 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
See the full eligibility criteria
- Patients with advanced squamous cell carcinoma of the oral cavity, pharynx, larynx or paranasal sinuses
- Severity of the disease: N1> 2 cm, N2, N3; T2, T3, T4, M0
- Patient eligible for radical treatment with induction chemotherapy (general condition at least good, no significant additional conditions disqualifying from induction chemotherapy)
- Signed informed consent to participate in the study
- ≥ 18 years of age
- Known or suspected hypersensitivity to any of the investigational drugs
- 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
- 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
- Pregnancy or breastfeeding (women of childbearing age should undergo a pregnancy test at screening)
- 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.
- 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
- Patients unable or unwilling to adhere to the study protocol.
- 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
- 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
- Coexistence of another neoplasm or a history of neoplastic disease with a significant potential influence on the tolerability or efficacy of iCHRTL
- 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
- Significant history of cerebrovascular disease within 6 months or current symptomatic or sequelae
- HIV infection
- 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
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.