Clinical Trials for Cervix Carcinoma Stage III
There is currently 1 ongoing clinical trial investigating treatment options for cervix carcinoma stage III, specifically focusing on cases where the cancer has spread to para-aortic lymph nodes. This trial is being conducted in France and examines whether adding initial chemotherapy with carboplatin and paclitaxel before standard treatment can improve patient outcomes.
Clinical trial locations
Study on the Effectiveness of Carboplatin and Paclitaxel in Treating Cervical Cancer with Para-aortic Lymph Node Involvement
This clinical trial is investigating a treatment approach for cervical cancer that has spread to the para-aortic lymph nodes, which are located near the aorta, a large blood vessel in the abdomen. The study aims to determine whether starting treatment with chemotherapy drugs before the standard treatment can improve how long patients survive.
Inclusion criteria: To participate in this trial, patients must be women aged 18 years or older with cervical cancer that has spread to the para-aortic lymph nodes. The cancer spread must be confirmed either by a specialized imaging test called 18F-FDG PET-CT or through tissue examination. Eligible patients must have one of three specific types of cervical cancer: adenocarcinoma, squamous cell carcinoma, or adenosquamous carcinoma, classified as FIGO stage IIIC2 or IVA. Participants need to be able to perform daily activities reasonably well, with an ECOG performance status of 0 to 2. They must have normal kidney function with creatinine clearance of at least 60 mL/min, normal liver function with bilirubin less than 1.5 times the upper normal limit and AST less than 3 times the upper normal limit, and adequate blood cell counts with platelets above 100,000 per microliter and neutrophils above 1,500 per microliter. Women of childbearing potential must have a negative pregnancy test before starting treatment. All participants must have social security insurance and provide written informed consent.
Exclusion criteria: This trial excludes patients who do not have cervical cancer or whose cancer has not spread to the para-aortic lymph nodes. Male patients cannot participate, as this study is specifically for cervical cancer. Patients who belong to vulnerable populations, such as those unable to provide informed consent, are also excluded.
Trial focus and treatment approach: The study tests whether adding three cycles of chemotherapy with paclitaxel and carboplatin before standard treatment improves outcomes compared to standard treatment alone. Participants first receive three cycles of induction chemotherapy combining paclitaxel, given at a concentration of 6 mg/ml, and carboplatin, given at a concentration of 10 mg/ml, both delivered directly into the bloodstream through a vein. After completing this initial phase, patients continue with standard concurrent chemoradiotherapy, which means receiving chemotherapy while also undergoing radiation therapy at the same time. This combined approach aims to target cancer cells more effectively.
The trial monitors several important outcomes throughout treatment. Researchers track overall survival, measuring the time from the start of the study until death from any cause. They also assess how well the tumor responds to treatment using specific evaluation criteria, the time until cancer progresses or returns, and patients’ quality of life through specialized questionnaires. Any side effects that occur during treatment are carefully monitored and recorded. The trial is expected to continue until January 2028.
Investigational drugs: Carboplatin is a chemotherapy medication that works by interfering with the DNA of cancer cells, preventing them from growing and dividing. It belongs to a class of drugs called platinum-based agents and is used in the induction phase to help shrink the cancer before the main treatment. Paclitaxel is another chemotherapy drug that stops cancer cells from dividing by stabilizing structures within cells called microtubules. It is combined with carboplatin during the initial treatment phase to enhance effectiveness. Both medications are well-established in cancer treatment and are given as intravenous infusions. The trial also includes concurrent chemoradiotherapy as the standard treatment following induction chemotherapy, combining chemotherapy with radiation therapy to make cancer cells more sensitive to radiation.
Summary
Currently, there is only one active clinical trial for stage III cervical cancer with para-aortic lymph node involvement, being conducted in France. This trial focuses on determining whether adding initial chemotherapy with carboplatin and paclitaxel before standard chemoradiotherapy can improve survival outcomes for patients with this advanced stage of the disease. The study uses well-established chemotherapy drugs and carefully monitors both treatment effectiveness and patient quality of life. Patients interested in participating should discuss eligibility requirements with their healthcare providers.