Treatment for advanced squamous cell carcinoma using chemotherapy and low-dose radiotherapy

Induction Treatment in Patients With Squamous Cell Carcinoma (SCC) of the Head and Neck Region Consisting Concomitant Chemotherapy and Low-dose Ionizing Radiotherapy

This study is testing a new treatment combining chemotherapy and low-dose radiation to see if it helps people with advanced squamous cell carcinoma in the mouth and throat feel better and have fewer side effects.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Maria Sklodowska-Curie National Research Institute of Oncology (other)
• Drugs / interventions: chemotherapy, radiation
• Locations: 1 site (Gliwice, Silesia)
• Trial ID: NCT05992610 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the efficacy and tolerability of a treatment regimen combining induction chemotherapy with carboplatin and paclitaxel alongside low-dose ionizing radiotherapy in patients with advanced squamous cell carcinoma of the oral cavity, pharynx, larynx, or paranasal sinuses. The study aims to enroll 40 patients who have not previously received treatment for their cancer and are in stages III or IV. Participants will undergo two cycles of treatment, with assessments of their response and tolerability, followed by imaging studies to determine further treatment options. The approach focuses on optimizing the therapeutic effects while minimizing side effects through careful planning of radiation doses.

Who should consider this trial

Good fit: Ideal candidates are adults over 18 with untreated advanced squamous cell carcinoma of the oral cavity, pharynx, larynx, or paranasal sinuses.

Not a fit: Patients with known hypersensitivity to the study medications or significant comorbidities that disqualify them from induction chemotherapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could improve outcomes for patients with advanced squamous cell carcinoma by enhancing tumor response and tolerability.

How similar studies have performed: While this approach is not widely tested, similar combinations of chemotherapy and radiotherapy have shown promise in treating advanced cancers, suggesting potential for success.

Eligibility criteria

Inclusion Criteria:

1. 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.
2. Severity of the disease: N1 \> 2 cm, N2, N3 ; T2, T3, T4, M0
3. 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).
4. Written informed consent form to the proposed therapeutic scheme.
5. Age over 18 years.

Exclusion Criteria:

1. Subjects with known or suspected hypersensitivity to any of the study mediations.
2. 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
3. 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.
4. Concomitant malignancy or history of a malignancy with a significant potential impact to tolerability or effectivity of iCHRTL.
5. 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.
6. History of significant cerebrovascular disease within 6 months or currently symptomatic or its implications.
7. Human Immunodeficiency Virus (HIV) infection.
8. 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.
9. 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.
10. 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.
11. 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.
12. Pregnancy or breastfeeding (women of childbearing potential must have pregnancy test performed during screening).
13. 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.
14. 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.
15. Patients who cannot or do not want to adhere to the study Protocol.

Where this trial is running

Gliwice, Silesia

• The Maria Sklodowska-Curie National Research Institute of Oncology, Branch in Gliwice — Gliwice, Silesia, Poland (RECRUITING)

Study contacts

• Study coordinator: Tomasz Rutkowski, MD PhD

Conditions: Squamous Cell Carcinoma of Oral Cavity, Pharynx Carcinoma, Larynx Carcinoma, Paranasal Sinus Carcinoma