Study Comparing Chemoradiotherapy with Fluorouracil, Cisplatin, and Carboplatin for Patients with Operable Esophageal Squamous Cell Carcinoma

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What is this study about?

This clinical trial is focused on studying treatments for esophageal squamous cell carcinoma, a type of cancer that occurs in the esophagus. The study compares two treatment approaches: one involves using a combination of chemotherapy and radiation therapy before surgery, known as neoadjuvant chemoradiotherapy, and the other involves using chemotherapy and radiation therapy as the main treatment, with surgery only if needed, known as definitive chemoradiotherapy. The goal is to determine if the second approach is as effective as the first in terms of overall survival.

The medications used in this study include Fluorouracil, Cisplatin, Carboplatin, Paclitaxel, Folinic Acid (also known as Leucovorin), and Oxaliplatin. These drugs are administered through an intravenous infusion, which means they are given directly into a vein. The study will monitor patients over a period of time to assess their overall survival, quality of life, and any side effects from the treatments.

Participants in the study will receive one of the two treatment plans and will be followed for several years to track their health outcomes. The study aims to provide valuable information on the effectiveness and safety of these treatment strategies for patients with operable, locally advanced esophageal squamous cell carcinoma.

1 initial treatment phase

The trial involves two main treatment strategies for esophageal squamous cell carcinoma. The first strategy is neoadjuvant chemoradiotherapy (nCRT) followed by surgery. The second strategy is definitive chemoradiotherapy (dCRT) with the option of surgery if needed.

In the nCRT group, patients receive a combination of chemotherapy drugs including fluorouracil, cisplatin, carboplatin, paclitaxel, folinic acid, and oxaliplatin. These medications are administered through an intravenous infusion, which means they are given directly into a vein.

The specific dosage and frequency of these medications are determined by the medical team based on individual patient needs and the treatment protocol.

2 surgery or observation

For patients in the nCRT group, surgery is performed after the completion of the chemoradiotherapy phase. The goal of the surgery is to remove any remaining cancerous tissue.

Patients in the dCRT group are monitored closely after the chemoradiotherapy phase. If necessary, surgery may be performed at a later stage if the cancer does not respond adequately to the initial treatment.

3 follow-up and monitoring

After the initial treatment phase, patients enter a follow-up period. This involves regular check-ups to monitor overall health and detect any signs of cancer recurrence.

The primary focus during this period is on overall survival and health-related quality of life. These are assessed at various intervals, including 6, 12, 24, 36, and 60 months after the start of the trial.

Additional assessments may include nutritional outcomes, surgical complications, and treatment-related side effects.

Who Can Join the Study?

The patient must have a type of esophageal cancer called squamous cell carcinoma, which is confirmed by a test called histopathology.
The cancer should be in a stage where it is considered locally advanced, meaning it has spread nearby but not to distant parts of the body.
The cancer must be technically resectable, meaning it can be removed by surgery, as decided by a team of medical experts.
The patient should have a performance status of ECOG 0-1, which means they are fully active or have some symptoms but can still do light work.
Women who can have children must have a negative pregnancy test before joining the study.
Patients who can have children should use a very effective method of birth control during the study and for at least six months after the last treatment.
The patient must give written consent to participate, following specific guidelines and regulations.
The patient must be between 18 and 80 years old.
The patient must have adequate organ function, meaning their organs are working well enough to participate in the study.
Women who are breastfeeding should stop nursing before starting the study treatment.

Who Cannot Join the Study?

Patients who have a different type of cancer than the one being studied.
Patients who have cancer that cannot be removed by surgery.
Patients who have other serious health conditions that could affect their ability to participate in the study.
Patients who are pregnant or breastfeeding.
Patients who are unable to follow the study procedures for any reason.
Patients who have participated in another clinical trial recently.
Patients who have allergies to the study medications.
Patients who have had a recent heart attack or other serious heart problems.
Patients who have an active infection that requires treatment.
Patients who have a history of another type of cancer within the last five years, except for certain skin cancers.

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
Region Oestergoetland	Linkoping	Sweden
Centre Hospitalier Universitaire De Lille	Lille	France
Centre Hospitalier Regional Et Universitaire De Brest	Brest	France
Oncopole Claudius Regaud	Toulouse	France
Oslo Universitetssykehus HF	Oslo	Norway

Other Sites

Site Name	City	Country
Hopital Saint Antoine	Paris	France
Region Skane Skanes Universitetssjukhus	Lund	Sweden
Universitetssykehuset Nord-Norge HF	Tromsø	Norway
Karolinska University Hospital	Solna	Sweden
Hopital Ambroise Pare	Boulogne-Billancourt	France
Centre Hospitalier Universitaire De Montpellier	Montpellier	France
Region Oerebro Laen	Orebro	Sweden
Region Vaesterbotten	Umea	Sweden
Centre Hospitalier Lyon Sud	Pierre Benite	France
Hopital Beaujon	Clichy	France
St. Olavs Hospital HF	Trondheim	Norway
Institut Sainte Catherine	Avignon	France
Centre Francois Baclesse	Caen	France
Coftxu Htybpvfennl Uezanupklzmdz Ryqwl	Reims	France
Czjglk Hfwcwejcyrz Utpschljxxwao Di Didqe	Dijon	France
Avomsbnjqp Paetkyle Hyrkqixr Dn Mgesryzje	Marseille	France
Ujjghnf Uxoycvtwub Hmnfilbf	Uppsala	Sweden
Broizpsz Uvfejibzyz Hlrlbeou Ccxszz	Besançon	France

Trial status

Country	Status	Recruitment Start
France	Recruiting	28.05.2022
Ireland	Recruiting	28.05.2022
Norway	Recruiting	28.05.2022
Sweden	Recruiting	28.05.2022

Trial locations

Investigated drugs:

Neoadjuvant Chemoradiotherapy (nCRT) is a treatment approach that combines chemotherapy and radiation therapy before surgery. The goal is to shrink the tumor in the esophagus, making it easier to remove during surgery. This approach is used for patients with esophageal squamous cell carcinoma to improve the chances of successful surgery and potentially enhance survival rates.

Definitive Chemoradiotherapy (dCRT) is a treatment that combines chemotherapy and radiation therapy as the main treatment without immediate surgery. In this trial, it is used for patients with esophageal squamous cell carcinoma. If the cancer does not respond completely or recurs, surgery may be performed later as a salvage option. This approach aims to control the cancer while avoiding surgery unless absolutely necessary.

Investigated diseases:

Oesophageal squamous cell carcinoma

Squamous Cell Carcinoma of the Esophagus – This is a type of cancer that forms in the squamous cells lining the esophagus, the tube that carries food from the throat to the stomach. It is considered locally advanced when it has spread to nearby tissues or lymph nodes but not to distant parts of the body. The disease often begins with difficulty swallowing and may progress to cause weight loss and chest pain. As it advances, it can lead to more severe swallowing problems and may cause a feeling of food being stuck in the throat. The progression of the disease can vary, with some cases remaining stable for a period while others may grow more rapidly.

Trial ID:

2022-500966-82-00

NCT ID:

NCT04460352

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study Comparing Chemoradiotherapy with Fluorouracil, Cisplatin, and Carboplatin for Patients with Operable Esophageal Squamous Cell Carcinoma

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?