Laryngeal cancer stage I Trials in Disease

Study of low-dose radiation therapy combined with paclitaxel and carboplatin in patients with advanced throat and larynx cancer

This clinical trial is evaluating a treatment approach that combines low-dose radiation therapy with two chemotherapy medications for patients with advanced throat and larynx cancer. The study aims to determine how effective this combined treatment is and how well patients tolerate it.

Main inclusion criteria:

• Patients must have advanced cancer of the throat or larynx that has not been previously treated
• The cancer must be at a specific stage with lymph node involvement larger than 2 cm or at N2 or N3 stage, with tumor size classified as T2, T3, or T4, and no distant spread
• Patients must be healthy enough to receive chemotherapy and not have other serious medical conditions that would prevent treatment
• Patients must be at least 18 years old
• Both men and women can participate

Main exclusion criteria:

• Patients younger than 18 or older than 65 years
• Presence of cancer that has spread to distant parts of the body
• Previous radiation therapy treatment in the head and neck area
• Active infections, significant heart problems, or severe kidney or liver dysfunction
• Pregnancy or breastfeeding
• Known allergies to the study medications
• Weakened immune system or autoimmune diseases
• Uncontrolled diabetes or active substance abuse

Focus and goals:

The trial focuses on treating advanced throat and larynx cancer using a treatment method called induction radiochemotherapy. This approach uses low doses of radiation combined with chemotherapy to treat the cancer. The study will monitor how patients respond to treatment by examining the cancer's response locally and in the lymph nodes, checking for any spread of the disease, and tracking overall patient survival. Researchers will also study how low doses of radiation affect the body at molecular and biochemical levels. Throughout the treatment period, which lasts up to 37 days, doctors will carefully monitor and record any side effects patients may experience. Follow-up monitoring will continue until December 2028 to track long-term outcomes.

Investigational drugs:

The trial uses two chemotherapy medications delivered through an intravenous line: paclitaxel and carboplatin. These medications are given as a solution directly into the vein. The chemotherapy is combined with low-dose radiation therapy. This combined approach, called radiochemotherapy, works by making cancer cells more sensitive to radiation and helping to destroy them more effectively. The radiation is delivered in carefully controlled amounts to minimize damage to healthy tissue while treating the cancer.