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

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What is this study about?

This clinical trial is focused on studying the treatment of Cervical Cancer, specifically in cases where the cancer has spread to the para-aortic lymph nodes. The trial will use a combination of two medications: Paclitaxel and Carboplatin. These medications are given as a solution through an intravenous infusion, which means they are delivered directly into the bloodstream through a vein. The purpose of the study is to determine if starting treatment with these medications, followed by the usual treatment of chemoradiotherapy, can improve the overall survival of patients compared to receiving the usual treatment alone.

Participants in the study will first receive three cycles of the medications Paclitaxel and Carboplatin. After this initial phase, they will continue with the standard treatment, which involves a combination of chemotherapy and radiation therapy given at the same time. This approach is known as concurrent chemoradiotherapy. The study will compare the outcomes of patients who receive this additional initial treatment with those who only receive the standard treatment.

The trial aims to assess various outcomes, including overall survival, which is the time from the start of the study until death from any cause. It will also look at how well the tumor responds to the treatment, the time until the cancer progresses or returns, and the quality of life of the participants. Additionally, the study will monitor any side effects that occur during the treatment. The trial is expected to continue until January 2028.

1 induction chemotherapy

Receive three cycles of induction chemotherapy.

Each cycle includes the administration of two medications: paclitaxel and carboplatin.

Paclitaxel is given as an intravenous infusion at a concentration of 6 mg/ml.

Carboplatin is administered as an intravenous infusion at a concentration of 10 mg/ml.

The purpose of this phase is to prepare the body for the next stage of treatment.

2 standard concurrent chemoradiotherapy

Undergo standard concurrent chemoradiotherapy.

This involves receiving chemotherapy while also undergoing radiation therapy.

The goal is to target cancer cells more effectively by combining these treatments.

3 monitoring and assessment

Regular monitoring of health and response to treatment.

Assessments include checking tumor response using specific criteria (RECIST 1.1 and PERCIST 1.0).

Progression-free survival is evaluated, which measures the time until cancer progresses or the patient passes away.

Quality of life is assessed using specific questionnaires (EORTC QLQ-C30 and QLQ-CX24).

Adverse events are monitored and recorded according to established guidelines (NCI-CTCAE version 5.0).

Who Can Join the Study?

Patient must have cervical cancer with para-aortic lymph node involvement. This means the cancer has spread to specific lymph nodes near the aorta, a large blood vessel in the body.
Patient must have a positive result from a test called 18F-FDG PET-CT, which checks for cancer activity in the lymph nodes, or a positive result from a histological examination, which is a detailed study of tissue samples.
Patient must sign a written document agreeing to participate in the study, known as informed consent.
Patient must have social security insurance or something similar.
Patient must be 18 years or older.
Patient must have an ECOG performance status of 0 to 2, which is a scale that measures how well a patient can perform daily activities.
Patient must have a FIGO stage IIIC2 or IVA diagnosis, which describes the extent of the cancer, with para-aortic lymph node involvement.
Patient must have one of the following types of cervical cancer: adenocarcinoma, squamous cell carcinoma, or adenosquamous carcinoma.
Patient must have normal kidney function, with a creatinine clearance of 60 mL/min or higher. This is a measure of how well the kidneys are working.
Patient must have 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. These are tests that check how well the liver is working.
Patient must have a normal blood test, with platelets greater than 100,000 per microliter and neutrophils greater than 1,500 per microliter. These are types of blood cells important for clotting and fighting infections.
Women who can have children and are not postmenopausal must have a negative pregnancy test before starting the study treatment.

Who Cannot Join the Study?

Patients who do not have cervical cancer cannot participate. Cervical cancer is a type of cancer that occurs in the cells of the cervix, which is the lower part of the uterus that connects to the vagina.
Patients who do not have para-aortic lymph node involvement cannot participate. This means the cancer has spread to the lymph nodes located near the aorta, a large blood vessel in the abdomen.
Only female patients are eligible to participate. Male patients cannot participate.
Patients who are not within the specified age range cannot participate. The age range for this trial is not specified in the provided data.
Patients who belong to a vulnerable population cannot participate. Vulnerable populations may include groups like children, pregnant women, or those unable to give consent.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
University Hospital Of Clermont-Ferrand	Clermont Ferrand	France
Clinique Pasteur	Toulouse	France
Centre Hospitalier Universitaire De Bordeaux	Bordeaux	France
Oncopole Claudius Regaud	Toulouse	France

Other Sites

Site Name	City	Country
Centre Hospitalier Universitaire De La Reunion	St Denis	France
Centre Hospitalier Universitaire De Poitiers	Poitiers	France
Centre Hospitalier Lyon Sud	Pierre Benite	France
Hopital Beaujon	Clichy	France
Institut de Cancérologie de l’Ouest	Saint-Herblain	France
Szxhyh Swgm Exgnweayuq	Creteil	France
Cviebe Hwrtaddukak Rihjfvui Uxrkoisshortr Dw Tlara	Tours	France
Imemmcsz Pftdemknkulooyb Clpiph Cirqgt	Marseille	France
Ciojwu Owwlw Ldoshld	Lille	France

Trial status

Country	Status	Recruitment Start
France	Not yet recruiting	17.07.2020

Trial locations

Investigated drugs:

Carboplatin is a chemotherapy medication used to treat various types of cancer. In this trial, it is used as part of the induction chemotherapy to help shrink the cancer before the main treatment. It works by interfering with the DNA of cancer cells, preventing them from growing and dividing.

Paclitaxel is another chemotherapy drug used in this trial. It is combined with Carboplatin during the induction phase to enhance the treatment’s effectiveness. Paclitaxel works by stopping cancer cells from dividing, which helps to slow down or stop the growth of the cancer.

Concurrent Chemoradiotherapy is the standard treatment used in this trial after the induction chemotherapy. It involves the use of chemotherapy and radiation therapy at the same time. This combination is designed to increase the effectiveness of the treatment by using chemotherapy to make cancer cells more sensitive to radiation.

Cervical Cancer – Cervical cancer is a type of cancer that occurs in the cells of the cervix, which is the lower part of the uterus connecting to the vagina. It often begins with precancerous changes in the cervix, which can develop into cancer over time if not detected and treated early. The disease progresses as cancer cells grow and invade deeper tissues of the cervix and may spread to nearby areas such as the vagina, pelvic lymph nodes, and other parts of the body. Symptoms may include abnormal vaginal bleeding, pelvic pain, or pain during intercourse, but early stages often have no symptoms. The progression of cervical cancer can vary, with some cases remaining localized for a long time, while others may spread more rapidly. Regular screening and early detection are crucial in managing the disease effectively.

Trial ID:

2024-513576-18-00

Protocol code:

RC31/17-0213

NCT ID:

NCT03534713

Trial Phase:

Therapeutic confirmatory (Phase III)

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?