Laryngeal cancer stage II 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 called induction radiochemotherapy, which combines low doses of radiation therapy with chemotherapy medications. The study aims to determine how effective and well-tolerated this combined treatment is for patients with advanced cancer of the throat and larynx.

Main inclusion criteria:

• Patients must have advanced cancer of the throat (upper, middle, or lower part) or larynx (voice box) that has not been treated before
• The cancer must be at a specific stage with lymph node involvement (N1 larger than 2 cm, or N2 or N3), tumor size T2, T3, or T4, and no distant spread (M0)
• Patients must be between 18 and 65 years old
• Patients must be healthy enough to receive chemotherapy and not have other serious medical conditions that would prevent treatment
• Both men and women can participate
• Patients must be willing and able to sign an informed consent form

Main exclusion criteria:

• Age below 18 or above 65 years
• Presence of cancer that has spread to other parts of the body (distant metastases)
• Previous radiation therapy treatment in the head and neck area
• Active infections, significant heart problems, or severe kidney or liver dysfunction
• Pregnancy or breastfeeding
• Weakened immune system (immunodeficiency) or autoimmune diseases
• Known allergies to the study medications
• Uncontrolled diabetes, active substance abuse, or alcoholism
• Participation in other clinical trials within the last 30 days

Focus and goals:

The trial focuses on evaluating the effectiveness and tolerability of a combined treatment approach using low-dose radiation therapy together with chemotherapy. Throughout the treatment period of up to 37 days, doctors will monitor how patients respond to the treatment by examining the cancer's response both locally and in the lymph nodes. The study will also track whether the cancer has spread to other parts of the body, monitor overall patient survival, and check for any signs that the cancer has returned.

The research will also examine how low doses of radiation affect the body at molecular and biochemical levels. The medical team will carefully watch for and record any side effects that patients may experience during treatment. Follow-up monitoring will continue until December 2028 to track long-term outcomes.

Investigational drugs:

The trial uses two main treatment approaches combined together:

• Paclitaxel and Carboplatin: These are chemotherapy medications given through an intravenous line (directly into a vein). They work together with radiation therapy to make cancer cells more sensitive to treatment and help destroy them more effectively.
• Low-dose radiation therapy: This treatment uses controlled amounts of ionizing radiation to target and destroy cancer cells in the throat and larynx area while minimizing damage to healthy tissue.

The combination of chemotherapy and radiation therapy (radiochemotherapy) is designed to provide better results than either treatment alone, with the study specifically evaluating the use of lower doses of radiation than standard treatment protocols.