Study of low-dose radiation therapy combined with paclitaxel and carboplatin in patients with advanced throat and larynx cancer
This clinical trial examines a treatment approach for patients with advanced cancer of the throat or voice box that combines lower doses of radiation therapy with two chemotherapy medications. The study aims to evaluate both how well this treatment works and how well patients tolerate it.
Who can participate: This study is designed for adults between 18 and 65 years old who have advanced cancer of the throat or larynx that has not been treated before. To qualify, your cancer must meet specific staging criteria, including lymph node involvement of N1 stage larger than 2 cm, or N2 or N3 stages, with tumor sizes classified as T2, T3, or T4. The cancer must not have spread to distant parts of the body. You must be healthy enough to receive chemotherapy and not have other serious medical conditions that would prevent this type of treatment. Both men and women can participate, and you must be willing to sign an informed consent form.
Who cannot participate: You cannot join this study if you are under 18 or over 65 years old. The trial excludes patients whose cancer has already spread to distant parts of the body, as well as those who have previously received radiation therapy in the head and neck area. Other exclusion criteria include active or uncontrolled infections, significant heart problems, severe kidney or liver dysfunction, pregnancy or breastfeeding, and participation in other clinical trials within the last 30 days. Patients with mental conditions that prevent understanding of trial requirements, known allergies to the study medications, weakened immune systems, autoimmune diseases, uncontrolled diabetes, active substance abuse or alcoholism, or inability to follow study procedures are also excluded.
Treatment approach: The study uses an approach called induction radiochemotherapy, which combines low doses of ionizing radiation with chemotherapy. The treatment involves two chemotherapy drugs delivered through an intravenous line: paclitaxel and carboplatin. These medications are given as a solution directly into your vein. The radiation therapy is delivered at lower doses than standard treatment protocols, and the research team will study how this affects the cancer at both molecular and biochemical levels.
What to expect: The treatment period lasts up to 37 days. During this time, your medical team will regularly monitor how your body responds to the treatment and check for any side effects. They will assess the effectiveness by examining how the cancer responds locally and in the lymph nodes. After the initial treatment phase, you will have follow-up assessments to check if the cancer has spread and to track your overall health and recovery. The medical team will also monitor for any signs that the cancer has returned and measure how long you remain free from cancer progression. Long-term monitoring will continue until December 2028, with regular checkups to detect any potential return of cancer early.
Study goals: The main focus of this research is to determine how effective and well-tolerated this combined treatment approach is for patients with advanced throat and larynx cancer. The study will monitor cancer response, check for disease spread, track overall patient survival, and record any side effects that patients experience throughout the treatment period.
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