Cervix carcinoma stage I Trials in Disease

Study on the Effectiveness of Carboplatin and Paclitaxel in Treating Cervical Cancer with Para-aortic Lymph Node Involvement

This trial is evaluating a new treatment approach for patients whose cancer has spread to the para-aortic lymph nodes, which are located near a large blood vessel called the aorta in the abdomen. The study is testing whether starting treatment with chemotherapy before the standard treatment can improve patient outcomes.

Main inclusion criteria:

• Women aged 18 years or older
• Confirmed diagnosis of cervical cancer that has spread to para-aortic lymph nodes (FIGO stage IIIC2 or IVA)
• Specific cancer types: adenocarcinoma, squamous cell carcinoma, or adenosquamous carcinoma
• Positive test results from either an 18F-FDG PET-CT scan showing cancer activity in lymph nodes, or tissue examination confirming cancer
• Ability to perform daily activities reasonably well (ECOG performance status of 0 to 2)
• Normal kidney function with creatinine clearance of 60 mL/min or higher
• Normal liver function with specific blood test results within acceptable ranges
• Normal blood counts including platelets and white blood cells
• Negative pregnancy test for women of childbearing age
• Social security insurance coverage

Main exclusion criteria:

• Patients without confirmed cervical cancer
• Patients whose cancer has not spread to para-aortic lymph nodes
• Male patients
• Vulnerable populations including those unable to give informed consent

Focus and goal:

The trial uses a three-step approach. First, participants receive three cycles of initial chemotherapy treatment with two medications delivered through an IV: paclitaxel (at 6 mg/ml concentration) and carboplatin (at 10 mg/ml concentration). This initial phase is designed to prepare the body for the next stage of treatment.

Second, patients undergo standard concurrent chemoradiotherapy, which means receiving chemotherapy and radiation therapy at the same time. This combination targets cancer cells more effectively than either treatment alone.

Third, throughout the trial and afterward, patients are regularly monitored to assess how well the treatment is working. This includes checking tumor response using specific measurement criteria, evaluating quality of life through questionnaires, and recording any side effects according to established medical guidelines.

The main goal is to determine whether this approach of starting with chemotherapy before the standard treatment improves overall survival compared to receiving only the standard treatment. The study also evaluates how long patients live without their cancer progressing, how well tumors respond to treatment, quality of life, and treatment side effects.

Investigational drugs:

The trial uses carboplatin and paclitaxel, both well-established chemotherapy medications. Carboplatin is a platinum-based drug that works by interfering with cancer cell DNA, preventing cells from growing and dividing. Paclitaxel is a taxane medication that stabilizes structures within cells called microtubules, which stops cancer cells from dividing and leads to their death. Both drugs are delivered through intravenous infusion during the initial treatment phase. The trial also includes standard concurrent chemoradiotherapy, which combines chemotherapy with radiation therapy to make cancer cells more sensitive to radiation treatment.

The trial is expected to continue until January 2028, allowing researchers sufficient time to gather data on long-term outcomes and treatment effectiveness.