Ongoing Clinical Trials for Cervix Carcinoma Stage IV
Currently, there is 1 ongoing clinical trial investigating treatment options for stage IV cervical cancer with para-aortic lymph node involvement. This trial is taking place in France and is testing a combination of chemotherapy drugs—carboplatin and paclitaxel—given before standard chemoradiotherapy treatment.
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 examining whether giving chemotherapy before standard treatment can improve outcomes for patients with advanced cervical cancer that has spread to the para-aortic lymph nodes. These are lymph nodes located near the aorta, a major blood vessel in the abdomen.
Main focus of the trial: The study aims to determine if starting treatment with three cycles of chemotherapy using paclitaxel and carboplatin, followed by the usual treatment of chemoradiotherapy, can help patients live longer compared to receiving only standard treatment. Both medications are delivered directly into the bloodstream through an intravenous infusion.
Investigational drugs: The trial uses two chemotherapy medications:
- Carboplatin: A platinum-based chemotherapy drug that interferes with cancer cell DNA, preventing the cells from growing and dividing.
- Paclitaxel: A chemotherapy drug that stops cancer cells from dividing by stabilizing structures inside the cells called microtubules.
- Concurrent chemoradiotherapy: After the initial chemotherapy, patients receive the standard treatment combining chemotherapy and radiation therapy at the same time to increase treatment effectiveness.
Who can participate:
- Female patients aged 18 years or older
- Diagnosed with cervical cancer (adenocarcinoma, squamous cell carcinoma, or adenosquamous carcinoma) at FIGO stage IIIC2 or IVA with para-aortic lymph node involvement
- Positive results from either an 18F-FDG PET-CT scan or tissue examination confirming cancer in the lymph nodes
- Able to perform daily activities reasonably well, measured by an ECOG performance status of 0 to 2
- Normal kidney function with creatinine clearance of 60 mL/min or higher
- Normal liver function with total bilirubin less than 1.5 times the upper limit of normal and AST less than 3 times the upper limit of normal
- Adequate blood counts with platelets greater than 100,000 per microliter and neutrophils greater than 1,500 per microliter
- Women of childbearing potential must have a negative pregnancy test before starting treatment
- Must have social security insurance or equivalent coverage
- Must provide written informed consent to participate
Who cannot participate:
- Patients without cervical cancer
- Patients whose cancer has not spread to para-aortic lymph nodes
- Male patients
- Patients considered part of vulnerable populations, such as those unable to provide informed consent
What the trial involves: Participants will first receive three cycles of induction chemotherapy with paclitaxel and carboplatin. After completing this initial phase, they will continue with standard concurrent chemoradiotherapy, which involves receiving chemotherapy while also undergoing radiation therapy. Throughout the trial, the research team will regularly monitor tumor response, progression-free survival (the time until cancer grows or spreads), quality of life, and any side effects that may occur. The trial is expected to continue until January 2028.
Summary
There is currently one active clinical trial for stage IV cervical cancer with para-aortic lymph node involvement, taking place in France. This trial is investigating whether adding induction chemotherapy with carboplatin and paclitaxel before standard chemoradiotherapy can improve survival outcomes for patients with this advanced form of the disease. The study focuses specifically on patients whose cancer has spread to the para-aortic lymph nodes and uses well-established chemotherapy drugs in a new treatment sequence. Patients interested in participating should discuss eligibility requirements with their healthcare provider, as the trial has specific criteria related to cancer stage, overall health status, and organ function.