Study of low-dose radiation therapy combined with paclitaxel and carboplatin in patients with advanced throat and larynx cancer
This trial is investigating a treatment approach called induction radiochemotherapy for patients with advanced throat and larynx cancer. The treatment combines low doses of radiation therapy with two chemotherapy medications, paclitaxel and carboplatin, which are given through an intravenous injection directly into the bloodstream.
Who can participate:
You may be eligible for this trial if you have advanced cancer of the throat or larynx that has not been treated before. Your cancer must be at a specific stage with lymph node involvement larger than 2 cm or at stage N2 or N3, with tumor classification of T2, T3, or T4, and no distant spread of the disease. You must be between 18 and 65 years old, healthy enough to receive chemotherapy, and free from other serious medical conditions that would prevent treatment. Both men and women can participate, and you must be willing and able to sign an informed consent form.
Who cannot participate:
You cannot join this trial if you are younger than 18 or older than 65 years, or if the cancer has spread to other parts of your body. Previous radiation treatment in the head and neck area, active infections, significant heart problems, severe kidney or liver dysfunction, pregnancy, or breastfeeding will prevent participation. Other exclusion factors include participation in other clinical trials within the last 30 days, mental conditions that prevent understanding of the trial requirements, known allergies to the study medications, weakened immune system, autoimmune diseases, uncontrolled diabetes, active substance abuse or alcoholism, and inability to follow study procedures.
What the trial involves:
The treatment combines low-dose radiation therapy with the chemotherapy drugs paclitaxel and carboplatin. During the initial treatment phase, you will receive both medications through an intravenous line as a solution directly into your vein. The treatment period lasts up to 37 days. Throughout this time, your medical team will regularly monitor how your body responds to the treatment and check for any side effects. They will also measure the effectiveness of the treatment by examining how the cancer responds locally and in the lymph nodes.
After the initial treatment, you will have follow-up assessments where the medical team will check if the cancer has spread to other parts of your body, track your overall health and recovery, and monitor for any signs that the cancer has returned. Long-term monitoring will continue until December 2028, with regular checkups to ensure any potential return of cancer is detected early.
Treatment medications:
The trial uses radiation therapy at low doses to target and destroy cancer cells in the throat and larynx area. The radiation is delivered in carefully controlled amounts to minimize damage to healthy tissue while treating the cancer. This is combined with chemotherapy using paclitaxel and carboplatin, which work together with the radiation to make cancer cells more sensitive to treatment and help destroy them more effectively.
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