Ongoing Clinical Trials for Cervix Carcinoma Stage III
There is currently 1 ongoing clinical trial investigating treatment approaches for Stage III cervical cancer with spread to para-aortic lymph nodes. This trial is testing whether adding initial chemotherapy with carboplatin and paclitaxel before standard treatment can improve outcomes for patients.
Clinical trial locations
Study on the Effectiveness of Carboplatin and Paclitaxel in Treating Cervical Cancer with Para-aortic Lymph Node Involvement
This trial is investigating a new treatment approach for patients whose cervical cancer has spread to the para-aortic lymph nodes, which are located near the aorta, a major blood vessel in the abdomen. The study aims to determine whether starting treatment with chemotherapy before the standard therapy can improve survival rates.
Main inclusion criteria:
- Patients must be 18 years or older
- Confirmed cervical cancer with spread to para-aortic lymph nodes, verified by PET-CT scan or tissue examination
- Cancer stage must be FIGO stage IIIC2 or IVA
- Cancer type must be adenocarcinoma, squamous cell carcinoma, or adenosquamous carcinoma
- Good general health with ability to perform daily activities (ECOG performance status 0-2)
- Normal kidney function with creatinine clearance of at least 60 mL/min
- Normal liver function with appropriate bilirubin and AST levels
- Adequate blood cell counts, including platelets above 100,000 per microliter and neutrophils above 1,500 per microliter
- For women of childbearing age who are not postmenopausal, a negative pregnancy test is required
- Must have social security insurance or equivalent coverage
Main exclusion criteria:
- Patients without confirmed cervical cancer
- Patients whose cancer has not spread to the para-aortic lymph nodes
- Male patients (only females are eligible)
- Patients belonging to vulnerable populations, such as those unable to provide informed consent
Focus and goal of the trial:
The trial follows a three-step approach. First, participants receive three cycles of induction chemotherapy using two medications: paclitaxel and carboplatin, both given through an intravenous infusion directly into the bloodstream. This initial phase is designed to prepare the body and shrink the cancer before the main treatment.
In the second step, patients undergo standard concurrent chemoradiotherapy, which means receiving chemotherapy and radiation therapy at the same time. This combination approach aims to target cancer cells more effectively by using both treatments together.
Throughout the trial, patients are closely monitored for how well the treatment is working, including regular assessments of tumor response, progression-free survival (the time until cancer grows or spreads), and quality of life. Any side effects are carefully tracked and recorded. The study will compare outcomes between patients who receive the additional initial chemotherapy and those who receive only standard treatment. 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 is administered intravenously at a concentration of 10 mg/ml as part of the induction chemotherapy phase.
Paclitaxel is another chemotherapy drug that stops cancer cells from dividing by stabilizing structures within the cells called microtubules. This helps slow down or stop cancer growth. It is given intravenously at a concentration of 6 mg/ml, combined with carboplatin during the initial treatment phase.
After the induction chemotherapy, patients receive concurrent chemoradiotherapy, which is the standard treatment combining chemotherapy and radiation therapy. The chemotherapy makes cancer cells more sensitive to radiation, potentially increasing the overall effectiveness of the treatment.
Summary
Currently, there is one active clinical trial specifically designed for Stage III cervical cancer with para-aortic lymph node involvement. This trial is being conducted in France and focuses on testing whether adding initial chemotherapy with carboplatin and paclitaxel before standard chemoradiotherapy can improve patient survival and outcomes. The study takes a comprehensive approach by monitoring not only survival rates but also tumor response, quality of life, and treatment side effects. Both carboplatin and paclitaxel are well-established chemotherapy medications that work through different mechanisms to target cancer cells. This trial represents an important effort to improve treatment outcomes for patients with advanced-stage cervical cancer.