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Study on Preserving the Voice Box in Patients with Advanced Laryngeal or Hypopharyngeal Cancer Using Cisplatin, Fluorouracil, and Docetaxel Therapy

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 treatments for squamous cell carcinoma of the larynx or hypopharynx, which are types of throat cancer that have advanced locally. The study aims to compare two different treatment approaches to see which one is more effective in preserving the function of the larynx, which is the voice box, and the pharyngoesophageal area, which is part of the throat and esophagus. The treatments being tested include a combination of chemotherapy drugs: cisplatin, 5-fluorouracil, and docetaxel. These drugs are used to kill cancer cells and are given through an infusion, which means they are delivered directly into the bloodstream through a vein.

Participants in the study will receive either the combination of these chemotherapy drugs followed by radiotherapy or a treatment where cisplatin is given at the same time as radiotherapy. Radiotherapy is a treatment that uses high-energy rays to target and destroy cancer cells. The purpose of the study is to determine which treatment method is better at helping patients survive without losing the function of their larynx or needing major surgery like a total laryngectomy, which is the removal of the larynx.

The study will take place over several months, and participants will be monitored for their response to the treatment, any side effects they experience, and their overall health. The goal is to find the most effective way to treat this type of cancer while preserving the patient's ability to speak and swallow normally. The study will also look at the overall survival rates and the quality of life of the participants during and after the treatment.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Induction chemotherapy

    The first phase involves receiving induction chemotherapy with three medications: docetaxel, fluorouracil, and cisplatin. These medications are administered through a vein, a process known as intravenous use.

    The specific dosages and frequency of administration will be determined by the healthcare team based on individual needs and responses.

  2. Step 2

    Radiotherapy

    Following the induction chemotherapy, the next step is radiotherapy. This treatment uses high-energy rays to target and destroy cancer cells in the larynx or hypopharynx.

    The duration and frequency of radiotherapy sessions will be specified by the healthcare provider.

  3. Step 3

    Concomitant chemotherapy and radiotherapy

    In this phase, cisplatin is administered concurrently with radiotherapy. This means that chemotherapy and radiotherapy are given at the same time to enhance the effectiveness of the treatment.

    The healthcare team will provide detailed instructions on the schedule and dosage.

  4. Step 4

    Follow-up and evaluation

    After completing the treatment phases, regular follow-up appointments will be scheduled to monitor health status and assess the effectiveness of the treatment.

    These evaluations may include physical examinations, imaging tests, and other assessments to ensure the preservation of laryngeal and pharyngoesophageal function.

Who can join the trial?

10 criteria

  • The patient must have a type of cancer called squamous cell carcinoma in the larynx or hypopharynx. This cancer should be locally advanced, meaning it has spread in the area but not to distant parts of the body.
  • The cancer must be confirmed by a test called a histological examination, which looks at tissue under a microscope.
  • The cancer should require a surgery called a total (pharyngo)-laryngectomy, which involves removing the larynx or part of the throat, but this surgery should be possible without needing to remove a circular part of the hypopharynx.
  • The cancer should be classified as T2 or T3, which are stages that describe the size and extent of the tumor, but it should not have massive infiltration of the endolarynx by a transglottic lesion.
  • The cancer should not have spread to distant parts of the body, which is confirmed by tests like a chest CT scan, an abdominal ultrasound or CT scan if there are liver issues, and a bone scan if there are local symptoms.
  • The patient should not have been treated for this cancer before.
  • The patient should have a Performance Status (PS) of 0 or 1, which means they are fully active or have some symptoms but do not need help with daily activities.
  • The size of the tumor should be measurable according to a standard called RECIST, which is a set of rules for measuring how tumors respond to treatment.
  • The patient can be of any gender.
  • The patient should not belong to a vulnerable population, which means they should not be in a group that needs special protection in research.

Who cannot join the trial?

10 criteria

  • Patients with other types of cancer besides the specific type being studied.
  • Patients who have had previous treatments that might interfere with the study results.
  • Patients with severe medical conditions that could make participation unsafe.
  • Patients who are pregnant or breastfeeding.
  • Patients who are unable to follow the study procedures for any reason.
  • Patients with allergies to the medications used in the study.
  • Patients who are participating in another clinical trial at the same time.
  • Patients with a history of substance abuse that could affect the study.
  • Patients with mental health conditions that might interfere with their ability to participate.
  • Patients who do not meet the age requirements for the study.
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Investigated drugs

  • Cisplatin

    is a chemotherapy medication used to treat various types of cancer. In this trial, it is used to help preserve the larynx by either being part of a combination therapy or administered alongside radiotherapy. It works by damaging the DNA of cancer cells, which prevents them from dividing and growing.

  • 5-Fluorouracil

    is another chemotherapy drug included in the trial. It is used to treat different cancers by interfering with the cancer cells' ability to make DNA and RNA, which are essential for their growth and division. In this study, it is part of the induction chemotherapy regimen aimed at preserving the larynx.

  • Docetaxel

    is a chemotherapy medication that is part of the induction chemotherapy regimen in this trial. It works by disrupting the normal function of microtubules in cancer cells, which are structures that help cells divide. This disruption leads to the death of cancer cells, contributing to the goal of laryngeal preservation.

  • Radiotherapy

    is a treatment that uses high-energy rays to target and kill cancer cells. In this trial, it is used in two ways: following the induction chemotherapy regimen or in combination with cisplatin. The aim is to destroy cancer cells while preserving the function of the larynx.

What is already known about the treatment

  • Cisplatin

    Cisplatin is administered intravenously and is used in the treatment of various cancers, including locally advanced squamous cell carcinomas of the larynx or hypopharynx. It is well-established in medical literature as a chemotherapy agent. The main therapeutic indication is to treat cancer by damaging the DNA of cancer cells, which prevents them from dividing and growing. Cisplatin is classified as a platinum-based chemotherapy drug.

  • 5-Fluorouracil

    5-Fluorouracil is given intravenously and is used to treat different types of cancer, including squamous cell carcinomas of the larynx or hypopharynx. It is a well-known medication in oncology. Its primary therapeutic use is to inhibit cancer cell growth by interfering with DNA and RNA synthesis. It belongs to the class of drugs known as antimetabolites.

  • Docetaxel

    Docetaxel is administered intravenously and is used for treating various cancers, including squamous cell carcinomas of the larynx or hypopharynx. It is recognized in medical literature as an effective chemotherapy agent. The main therapeutic indication is to disrupt the microtubule network in cells, which is essential for cell division, thus inhibiting cancer cell growth. Docetaxel is classified as a taxane chemotherapy drug.

Investigated diseases

  • Squamous Cell Carcinoma of the Larynx

    This is a type of cancer that begins in the flat cells lining the larynx, or voice box. It is characterized by the abnormal growth of these cells, which can form a mass or tumor. As the disease progresses, it may cause symptoms such as hoarseness, difficulty swallowing, or a persistent sore throat. The cancer can spread to nearby tissues or lymph nodes, affecting the function of the larynx. Over time, it may lead to more severe complications if not managed. The progression can vary, with some cases remaining localized while others may spread to distant parts of the body.

  • Squamous Cell Carcinoma of the Hypopharynx

    This cancer originates in the squamous cells of the hypopharynx, the area where the larynx and esophagus meet. It typically presents with symptoms like difficulty swallowing, a lump in the neck, or ear pain. As it advances, the tumor can invade surrounding tissues and structures, potentially leading to breathing or swallowing difficulties. The disease may spread to nearby lymph nodes or distant organs. The progression can be aggressive, with the potential for significant impact on the patient's quality of life. Early detection is crucial to manage its spread and preserve function.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-513976-16-00Estimated enrolment256 patientsSponsorGroupe Oncologie Radiotherapie Tete Cou

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