Ongoing Clinical Trials for Oropharyngeal Cancer
This article provides information about 4 ongoing clinical trials studying new treatments for oropharyngeal cancer. These trials are investigating different treatment approaches including chemotherapy combinations, immunotherapy, electrochemotherapy, and methods to reduce treatment side effects while maintaining effectiveness. Trials are currently taking place in Belgium, France, Germany, Ireland, and Italy.
Clinical trial locations
- Belgium
- France
- Germany
- Ireland
- Italy
Study of Cisplatin, Carboplatin and Durvalumab Treatment for Patients with Intermediate and High-Risk Oropharyngeal Cancer
This trial is being conducted in Ireland and focuses on comparing different treatment combinations for patients with intermediate and high-risk forms of the disease. The study combines chemotherapy drugs with immunotherapy alongside radiation therapy.
Main inclusion criteria: Patients must be between 18 and 70 years old with a confirmed diagnosis of squamous cell carcinoma in the throat area, specifically affecting the base of the tongue, tonsils, or uvula. Participants need to be in good overall physical condition, able to carry out normal daily activities, with an expected survival of at least 3 months. Normal kidney, liver, and blood function is required. Women of childbearing age must have a negative pregnancy test, and all participants must be willing to attend all scheduled visits.
Main exclusion criteria: The trial excludes patients under 18 or over 65 years old, those who have previously received chemotherapy or radiation treatment to the head and neck area, or who have undergone surgery for this cancer. Patients with cancer that has spread to distant parts of the body, those who are pregnant or breastfeeding, or individuals with active serious infections including HIV cannot participate. Those with serious heart or lung conditions, other active cancers in the past five years, mental health conditions affecting study participation, or drug or alcohol dependency are also excluded.
Treatment focus: The study investigates whether combining cisplatin and carboplatin chemotherapy with durvalumab, an immunotherapy medication that helps the immune system fight cancer, together with radiation therapy can improve survival rates. The trial closely monitors patients’ overall health, quality of life, and swallowing ability throughout treatment.
Investigational drugs: The trial uses cisplatin and carboplatin, which are chemotherapy medications that damage cancer cell DNA, and durvalumab, an immunotherapy drug administered through intravenous infusion that helps the body’s immune system detect and attack cancer cells.
Study on Electrochemotherapy with Bleomycin for Patients with Recurrent Oral and Oropharyngeal Cancer
This Italian trial investigates a treatment approach called electrochemotherapy for patients whose cancer has returned or is progressing. The study compares this newer technique with standard combination chemotherapy.
Main inclusion criteria: Participants must be over 18 years old with progressive disease in the oral cavity and throat that has been confirmed through tissue testing to be squamous cell carcinoma. The cancer must have measurable areas that can be treated with electrical impulses. Patients need a performance status of Karnofsky score 70 or WHO score 2, meaning they can still carry out most daily activities, and a life expectancy of more than 3 months. Participants must understand the treatment and provide informed consent, and must have refused other available treatments.
Main exclusion criteria: Patients with any cancer type other than squamous cell carcinoma of the oral cavity and throat cannot participate. Those outside the specified age range, members of vulnerable populations unable to give consent, patients not eligible for the specific treatment being tested, or individuals with medical conditions that doctors believe would make participation unsafe are excluded.
Treatment focus: The trial tests whether electrochemotherapy, which combines electrical pulses with the chemotherapy drug bleomycin, is more effective than a standard combination of cetuximab, platinum-based therapy, and 5-fluorouracil. The electrical pulses help the drug enter cancer cells more effectively. Researchers monitor how well the cancer responds, overall survival, disease control duration, and quality of life.
Investigational drugs: The study uses bleomycin, a chemotherapy drug that damages cancer cell DNA; cetuximab, which targets specific proteins on cancer cell surfaces; platinum-based chemotherapy drugs; and 5-fluorouracil, which interferes with cancer cells’ ability to make DNA and RNA.
Study on Reducing Treatment Intensity for Patients with HPV-Positive Oropharyngeal Cancer Using Cisplatin and Carboplatin
This trial, conducted in France and Germany, explores whether reducing the intensity of treatment after surgery can maintain effectiveness while improving swallowing function and reducing side effects for patients whose cancer is linked to the human papillomavirus.
Main inclusion criteria: Patients must be 18 years or older with confirmed or suspected squamous cell carcinoma in the throat that has tested positive for HPV using specific tests. Participants need to be suitable candidates for both surgery and additional treatments including chemotherapy and radiotherapy, as determined by a multidisciplinary medical team. They must have adequate bone marrow function and kidney function sufficient to receive cisplatin chemotherapy. The cancer must be at a specific stage according to standard classification systems, and patients must be fit for surgery involving tumor removal through the mouth and possibly removal of lymph nodes in the neck.
Main exclusion criteria: Patients without HPV-positive cancer, those outside the specified age range, individuals not part of the designated study groups, or members of vulnerable populations unable to provide consent cannot participate.
Treatment focus: Following surgery to remove the tumor through the mouth, the study evaluates reduced-intensity additional treatments using cisplatin chemotherapy and radiation therapy. The goal is to find a balance between effective cancer treatment and minimizing negative impacts on daily life, particularly swallowing ability and overall well-being.
Investigational drugs: The trial uses cisplatin, a chemotherapy medication given after surgery to eliminate remaining cancer cells, combined with radiation therapy that uses high-dose radiation to target any remaining cancer cells following surgery.
Study on Swallowing and Quality of Life in Advanced Head and Neck Cancer Patients Using Cisplatin and Drug Combination
This Belgian trial examines how different approaches to feeding tube placement affect patients’ swallowing ability and quality of life after receiving chemotherapy and radiation therapy for advanced disease.
Main inclusion criteria: Patients must be at least 18 years old with newly diagnosed, confirmed squamous cell carcinoma in the mouth, throat, or voice box area. They must be candidates for curative treatment including radiation and medication, without any previous cancer treatment. Women of childbearing age must agree to use effective birth control and have a negative pregnancy test within 7 days before treatment begins. Participants need adequate bone marrow, liver, and kidney function, with mild or no nerve damage or hearing impairment. They must have an ECOG performance status of 2 or less and be able to complete study questionnaires.
Main exclusion criteria: Patients without the specified cancer type, those outside the age range, individuals unwilling to follow study procedures, pregnant or breastfeeding women, those with other interfering medical conditions, and members of vulnerable populations unable to give informed consent cannot participate.
Treatment focus: The study compares two feeding tube strategies: placing the tube before treatment begins versus placing it only if needed during treatment. Researchers assess how these approaches affect swallowing ability and quality of life six months after completing treatment, helping determine the best way to support patients’ nutritional needs during and after cancer treatment.
Investigational drugs: The trial uses cisplatin chemotherapy administered through intravenous infusion to stop or slow cancer cell growth, combined with radiotherapy that uses high-dose radiation to kill cancer cells. A feeding tube may be placed to maintain nutrition for patients experiencing difficulty swallowing.
Summary
The four ongoing clinical trials for oropharyngeal cancer reflect diverse approaches to improving treatment outcomes and patient quality of life. Geographically, trials are distributed across five European countries, with representation in Western and Central Europe. Each trial addresses different aspects of disease management: one focuses on treatment intensification for intermediate and high-risk patients, another explores innovative electrochemotherapy for recurrent disease, a third investigates treatment de-intensification for HPV-positive cases, and the fourth examines supportive care strategies during treatment.
A common theme across these trials is the use of platinum-based chemotherapy, particularly cisplatin and carboplatin, often combined with radiation therapy. Several studies emphasize patient-centered outcomes such as swallowing function and quality of life, recognizing that treatment success extends beyond cancer control to maintaining daily functioning. The trials addressing HPV-positive cancer and reduced treatment intensity reflect growing understanding that some patient groups may benefit from less aggressive approaches, while others with higher-risk disease may require treatment intensification.
These trials collectively represent efforts to personalize treatment based on disease characteristics, improve effectiveness through novel approaches like immunotherapy and electrochemotherapy, and balance cancer control with preservation of quality of life.
