Not recruiting

Study on Chemotherapy with Cisplatin, Fluorouracil, and Docetaxel for Patients with Locally Advanced Squamous Cell Carcinoma

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a type of cancer called squamous cell carcinoma, which can occur in areas such as the mouth, throat, and voice box. The study is investigating a combination of three chemotherapy drugs: cisplatin, 5-fluorouracil (also known as 5-FU), and docetaxel. These medications are used to treat cancer by stopping the growth of cancer cells. The purpose of the study is to evaluate how effective this combination of drugs is in treating the cancer while minimizing side effects.

Participants in the study will receive the chemotherapy drugs through an intravenous infusion, which means the medication is given directly into a vein. The treatment will be administered over a period of several weeks, with the specific schedule and doses adjusted to suit each participant's needs. Some participants may receive a placebo as part of the study. The study aims to monitor the response to treatment and any side effects that may occur.

The trial will assess various outcomes, including the success rate of the treatment after eight weeks, overall survival, and the ability to control the cancer locally. It will also look at the preservation of the voice box and the absence of cancer spread to other parts of the body. Additionally, the study will evaluate the quality of life of participants using specific questionnaires. The trial is designed to provide valuable information on the effectiveness and safety of this chemotherapy combination for patients with locally advanced squamous cell carcinoma.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, the patient will be informed about the trial's purpose, which is to evaluate the effectiveness of a combination of medications: cisplatin, 5-fluorouracil, and docetaxel at adapted doses.
The patient will be assessed to ensure they meet the inclusion criteria, such as having a specific type of cancer, being within the age range of 18 to 75 years, and having a life expectancy of at least 3 months.
Step 2
Treatment administration
The patient will receive the treatment through intravenous infusion. This involves administering the medication directly into the bloodstream.
The medications used are Cisplatine Hospira, Docetaxel Hospira, and Fluorouracil Accord. The specific dosages and frequency will be adapted to the patient's needs.
Step 3
Monitoring and evaluation
The patient's response to the treatment will be monitored regularly. This includes evaluating the effectiveness of the treatment and checking for any side effects.
The primary goal is to assess the rate of patient success at 8 weeks. Secondary evaluations include overall survival, progression-free survival, and the rate of patients with larynx preservation.
Step 4
Completion of treatment
The treatment phase will conclude once the patient has received the entire induction treatment and any necessary complementary treatments.
The patient's quality of life will be assessed using specific questionnaires to understand the impact of the treatment on daily living.
Step 5
Follow-up
After completing the treatment, the patient will continue to be monitored for any long-term effects and overall health outcomes.
The study aims to gather data on the patient's survival and any progression of the disease, as well as any potential metastasis.

Who can join the trial?

8 criteria

Have a type of cancer called squamous cell carcinoma in the mouth, throat, or voice box, confirmed by a test.
The tumor cannot be removed by surgery or surgery would cause significant harm.
Have not received any previous treatment for head and neck cancer.
Be older than 18 years but younger than 75 years.
Have a performance status (PS) of 0 or 1, which means being fully active or having some symptoms but still able to do light work, according to the World Health Organization (WHO).
Have at least one tumor that can be measured using specific guidelines called RECIST 1.1 criteria.
Be able to receive a specific combination of cancer drugs called TPF, based on certain criteria.
Have an estimated life expectancy of at least 3 months.

Who cannot join the trial?

6 criteria

Patients with other types of cancer besides locally advanced squamous cell carcinoma cannot participate. This type of cancer affects certain cells in the body and is more advanced but not spread to distant parts.
Patients who have had a different treatment for their cancer recently may not be eligible.
Patients with severe health conditions that could interfere with the study treatment are excluded. This means if you have other serious illnesses, you might not be able to join.
Patients who are pregnant or breastfeeding cannot participate, as the study treatment might affect the baby.
Patients who are unable to follow the study procedures or attend regular check-ups are not eligible. This means if you can't come to the appointments or follow the study rules, you might not be able to join.
Patients with known allergies to the study drugs, such as cisplatin, 5FU, or docetaxel, cannot participate. These are the medicines being tested in the study.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

CHU Croix Rousse-Lyon
Verified
Lyon, France
Centre Hospitalier Intercommunal Creteil
Verified
Creteil, France
Centre Hospitalier Universitaire De Caen Normandie
Verified
Caen, France

Trial locations

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Investigated drugs

Cisplatin
is a chemotherapy medication used to treat various types of cancer. In this trial, it is used as part of a combination therapy to help stop the growth of cancer cells in patients with locally advanced squamous cell carcinoma.
5-Fluorouracil
, often abbreviated as 5-FU, is another chemotherapy drug included in the trial. It works by interfering with the cancer cells' ability to grow and divide, which can help reduce the size of tumors and slow the progression of the disease.
Docetaxel
is a chemotherapy medication that is used in this trial to treat squamous cell carcinoma. It helps to prevent cancer cells from dividing and growing, which can lead to a reduction in tumor size and an improvement in symptoms.

What is already known about the treatment

Cisplatin
Cisplatin is administered intravenously and is widely used in cancer treatment. It is currently well-established in medical practice and literature as a chemotherapy agent. Its main therapeutic indication is for treating various types of cancer, including locally advanced squamous cell carcinoma. At the molecular level, cisplatin works by binding to DNA and causing cross-linking, which interferes with DNA replication and ultimately leads to cell death. It is classified as a platinum-based chemotherapy drug.
5-Fluorouracil
5-Fluorouracil is given intravenously and is a common chemotherapy medication. It is well-documented in medical literature and is used to treat several types of cancer, including squamous cell carcinoma. Its mechanism of action involves inhibiting the enzyme thymidylate synthase, which is crucial for DNA synthesis, thereby preventing cancer cell growth. It belongs to the class of antimetabolite drugs.
Docetaxel
Docetaxel is administered intravenously and is a well-known chemotherapy drug. It is extensively used in medical practice for treating various cancers, including squamous cell carcinoma. Docetaxel works by stabilizing microtubules and preventing their disassembly, which disrupts cell division and leads to cancer cell death. It is classified as a taxane chemotherapy agent.

Investigated diseases

Locally Advanced Squamous Cell Carcinoma – This is a type of cancer that begins in the squamous cells, which are flat cells found in the skin and the lining of some organs. When it is described as "locally advanced," it means the cancer has spread beyond the original site but has not yet metastasized to distant parts of the body. The progression of this disease involves the growth of cancerous cells in nearby tissues and possibly lymph nodes. Symptoms may include a persistent sore, a lump, or changes in the skin or mucous membranes. As the disease advances, it can cause more noticeable symptoms depending on the location, such as difficulty swallowing or changes in voice if it affects the throat.