Ongoing Clinical Trials for Laryngeal Cancer Stage II
Currently, there is one ongoing clinical trial for patients with Stage II laryngeal cancer. This trial is investigating a combination treatment approach using low-dose radiation therapy together with chemotherapy drugs paclitaxel and carboplatin. The trial is being conducted in Poland and is open to eligible patients with advanced throat and larynx cancer.
Clinical trial locations
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.
Summary
Currently, there is one clinical trial available for patients with Stage II laryngeal cancer, located in Poland. This trial represents an important research effort to evaluate whether a combined treatment approach using low-dose radiation therapy with paclitaxel and carboplatin can effectively treat advanced throat and larynx cancer while potentially reducing treatment-related side effects.
The trial is specifically designed for patients aged 18 to 65 who have not received previous treatment for their cancer and who are healthy enough to undergo chemotherapy. The study will provide valuable information about the effectiveness and safety of this treatment combination, with long-term follow-up continuing through 2028.
Patients interested in this trial should discuss with their healthcare provider whether they meet the eligibility criteria and whether participation might be appropriate for their specific situation.