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Study on Reducing Chemotherapy for Patients with Low-Risk Localized Gastroesophageal Cancer Using Docetaxel, Oxaliplatin, Calcium Folinate, and Fluorouracil

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 gastroesophageal adenocarcinoma, which affects the stomach and the area where the stomach meets the esophagus. The study is specifically for patients who have a low risk of the cancer coming back after surgery. These patients have already completed a type of chemotherapy before surgery and had a successful removal of the cancer. The purpose of the study is to compare the effectiveness and safety of reducing the amount of chemotherapy given after surgery versus the standard amount usually given.

The study involves several medications used in chemotherapy. These include Docetaxel, Oxaliplatin, Calcium Folinate (also known as Leucovorin Calcium), and Fluorouracil (also known as 5-FU). These medications are given through an intravenous infusion, which means they are delivered directly into the bloodstream through a vein. Some patients in the study will receive these medications, while others may receive a placebo, which looks like the medication but does not contain any active ingredients.

Participants in the study will be randomly assigned to one of two groups. One group will receive the standard chemotherapy treatment after surgery, while the other group will have a reduced treatment plan, focusing more on monitoring and surveillance. The study will follow participants for several years to see how well they do in terms of survival and whether the cancer returns. The goal is to find out if less chemotherapy can be just as effective and safe as the standard treatment for patients with a low risk of cancer recurrence.

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 is randomly assigned to one of two groups: the de-escalation group or the standard chemotherapy group.
The assignment is based on a random selection process to ensure unbiased results.
Step 2
De-escalation group
Patients in this group will undergo regular surveillance without receiving additional chemotherapy after surgery.
The focus is on monitoring the patient's health and detecting any signs of cancer recurrence through scheduled check-ups.
Step 3
Standard chemotherapy group
Patients in this group will receive post-operative chemotherapy as part of the standard treatment protocol.
The treatment includes the administration of the following medications:
Docetaxel: Administered via intravenous injection. The dosage and frequency are determined by the healthcare provider.
Oxaliplatin: Administered via intravenous infusion. The dosage and frequency are determined by the healthcare provider.
Calcium folinate: Administered via intravenous infusion. The dosage and frequency are determined by the healthcare provider.
Fluorouracil: Administered via intravenous infusion. The dosage and frequency are determined by the healthcare provider.
Step 4
Monitoring and follow-up
Both groups will have regular follow-up appointments to monitor health status and detect any signs of cancer recurrence.
These appointments may include physical examinations, imaging tests, and laboratory tests as needed.
Step 5
End of study participation
The study aims to evaluate the 3-year overall survival rate and disease-free survival rate.
Participation in the study will continue until the study's estimated end date in October 2031, or until the patient completes the required follow-up period.

Who can join the trial?

13 criteria

Must be at least 18 years old.
Must have a type of cancer called **adenocarcinoma** in the stomach, esophagus, or where the stomach and esophagus meet, and it must not have spread to other parts of the body (non-metastatic).
Must have completed a specific type of chemotherapy before surgery, known as **FLOT**, which includes four cycles of treatment.
Must have had a successful surgery to remove the cancer, with no cancer cells left behind when viewed under a microscope (microscopically complete resection).
Must have a low risk of the cancer coming back, which means no cancer in the lymph nodes and specific characteristics of the tumor.
Must have a good level of daily functioning, as measured by a scale called **ECOG Performance Status**, with a score of 0 or 1.
Must be healthy enough to receive chemotherapy after surgery.
The time between surgery and joining the study must be no more than 10 weeks.
Must have organs that are working well enough, as defined by the study's guidelines.
Must not have any medical reasons that would prevent participation in the study assessments.
Must have signed a consent form agreeing to participate in the study.
Women who can have children must agree to use effective birth control or not engage in heterosexual activity during the study and for a certain period after treatment ends. Men must also use birth control during treatment and for a specified time afterward.
Must have medical insurance or an equivalent form of coverage.

Who cannot join the trial?

5 criteria

Patients with a high risk of the disease coming back cannot participate.
Patients who have not completed the required pre-operative chemotherapy treatment cannot participate. This treatment includes specific drugs called fluoropyrimidine and platinum, given in 4 cycles.
Patients who have not had a complete removal of the tumor, confirmed by a microscope, cannot participate.
Patients with cancer that has spread to other parts of the body (metastatic cancer) cannot participate.
Patients with cancer types other than gastric (stomach), esophageal (food pipe), or gastroesophageal junction (where the stomach meets the esophagus) adenocarcinoma cannot participate.

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Verified sites

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

Verified
Assistance Publique Hopitaux De Paris
Paris, France
Responsive
CHRU De Nancy
Vandoeuvre Les Nancy, France
Verified
Centr Georges Francois Leclerc
Dijon, France

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Investigated drugs

FLOT
is a combination chemotherapy regimen used before surgery in this trial. It includes four different medications that work together to shrink the tumor and make it easier to remove surgically. This regimen is typically used for treating certain types of stomach and esophageal cancers. The goal of using FLOT is to reduce the size of the cancer and improve the chances of a successful surgery.
Standard Adjuvant Chemotherapy
is the usual treatment given after surgery to help eliminate any remaining cancer cells and reduce the risk of the cancer coming back. In this trial, it is used as a comparison to see if reducing the amount of chemotherapy (de-escalation) is as effective as the standard approach. This therapy is important for patients who have undergone surgery to ensure that any microscopic cancer cells left behind are treated.
Surveillance
is a strategy used in this trial as an alternative to standard chemotherapy after surgery. Instead of receiving additional chemotherapy, patients are closely monitored for any signs of cancer returning. This approach is being tested to see if it can be as effective as standard chemotherapy in patients who are at low risk of their cancer coming back. The goal is to reduce the side effects and burden of treatment while still maintaining good outcomes for the patient.

What is already known about the treatment

Fluoropyrimidine-Platinum Regimen – This medication is administered intravenously as part of a chemotherapy treatment plan. It is currently used in medical practice and literature for treating certain types of cancer, specifically non-metastatic gastric, esophageal, or gastroesophageal junction adenocarcinoma. The main therapeutic indication is to reduce the risk of cancer recurrence after surgery. At the molecular level, the mechanism of action involves interfering with DNA synthesis and repair, which prevents cancer cells from dividing and growing. This regimen falls under the pharmacological classification of antineoplastic agents, which are drugs used to treat cancer.

Investigated diseases

Gastric Adenocarcinoma
This is a type of cancer that begins in the glandular cells of the stomach lining. It often progresses slowly and may not show symptoms in the early stages. As it advances, it can cause symptoms like stomach pain, nausea, and weight loss. The disease can spread to nearby organs and lymph nodes. It is typically classified based on the depth of tumor invasion and lymph node involvement. Early detection is crucial for managing the disease effectively.
Esophageal Adenocarcinoma
This cancer originates in the cells of the esophagus, particularly in the lower part where it meets the stomach. It is often associated with chronic acid reflux and Barrett's esophagus. The disease progresses by invading deeper layers of the esophagus and potentially spreading to nearby lymph nodes. Symptoms may include difficulty swallowing, chest pain, and unintended weight loss. The progression is typically assessed by the size and spread of the tumor. Early intervention can help manage the disease's impact.
Gastroesophageal Junction Adenocarcinoma
This cancer occurs where the esophagus meets the stomach, affecting the cells in this junction area. It shares characteristics with both gastric and esophageal adenocarcinomas. The disease can progress by growing into surrounding tissues and spreading to lymph nodes. Symptoms often include difficulty swallowing, heartburn, and weight loss. The classification of the disease depends on the tumor's location and extent of spread. Understanding its progression is key to determining appropriate management strategies.