Not recruiting

Study comparing chemotherapy with or without radiation therapy in patients with resectable gastroesophageal junction cancer using docetaxel, oxaliplatin, fluorouracil and calcium folinate

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 study focuses on treating adenocarcinoma of the gastroesophageal junction, which is cancer occurring where the esophagus (food pipe) meets the stomach. The treatment involves a combination of chemotherapy medications including fluorouracil, docetaxel, oxaliplatin, and calcium folinate, which are given through an intravenous line directly into the bloodstream.

The purpose of this research is to determine if adding radiation therapy to chemotherapy before surgery works better than using chemotherapy alone before and after surgery for treating this type of cancer. The study compares these two different approaches to find out which one is more effective at preventing the cancer from returning.

Patients who participate in the study will receive treatment for approximately 33 weeks. During this time, they will receive either chemotherapy alone or chemotherapy combined with radiation therapy, followed by surgery to remove the cancer. After surgery, doctors will monitor the patients' progress to see how well the treatment worked and check for any side effects.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial evaluation
Your doctor will confirm the presence of adenocarcinoma of the gastroesophageal junction (cancer where the esophagus meets the stomach) through tissue examination
Medical tests will check your blood counts, liver function, kidney function, and heart rhythm to ensure you can safely participate in the treatment
Step 2
Treatment assignment
You will be randomly assigned to one of two treatment groups
Both groups will receive chemotherapy, but one group will also receive radiation therapy
Step 3
Treatment period
You will receive treatment with four medications through an intravenous line (directly into your vein):
- Fluorouracil
- Docetaxel
- Oxaliplatin
- Calcium folinate
If you are in the radiation therapy group, you will receive this treatment alongside chemotherapy
Step 4
Surgery
After completing the initial treatment, you will undergo surgery to remove the tumor
The surgery will include removal of lymph nodes to check for cancer spread
Step 5
Follow-up period
Regular check-ups will monitor your recovery and track any cancer progression
You will complete quality of life questionnaires during this period
The study will continue until June 2025
Step 6
Safety considerations
Side effects will be monitored and recorded throughout the treatment
You must use effective birth control during treatment and for 6 months afterward
Regular blood tests will monitor your health throughout the study

Who can join the trial?

12 criteria

Have a confirmed diagnosis of gastroesophageal junction cancer (a type of cancer where the esophagus meets the stomach) that is locally advanced but potentially removable by surgery
Be considered suitable for curative surgery as determined by the surgeon
Have an ECOG performance status of 0-1 (able to carry out all or most daily activities)
Be 18 years or older
Have adequate blood cell counts: - Neutrophils (white blood cells) ≥ 1.5 x 109/l - Platelets ≥ 100 x 109/l - Hemoglobin (red blood cell protein) ≥ 9.0 mg/dl
Have normal blood clotting function tests within 7 days before starting the study
Have adequate liver function with liver enzyme levels no more than 2.5 times the normal limit
Have adequate kidney function with creatinine levels no more than 1.5 times the normal limit
Have a normal heart rhythm measurement (QTc interval ≤ 440 ms)
Provide written informed consent before joining the study
For women who can become pregnant: have a negative pregnancy test within 7 days before starting treatment
Both men and women must agree to use effective birth control during the study and for 6 months after treatment ends

Who cannot join the trial?

14 criteria

Age under 18 or over 75 years old
Inability to undergo surgery due to medical conditions
Previous cancer treatment for gastroesophageal junction adenocarcinoma
Presence of distant metastases (cancer spread to distant organs)
Significant heart conditions that would interfere with treatment
Severe kidney or liver dysfunction
Pregnancy or breastfeeding
Active infectious diseases including hepatitis B, hepatitis C, or HIV
Other types of cancer within the last 5 years
Mental conditions that would prevent understanding of the trial requirements
Inability to follow study procedures or attend follow-up visits
Contraindications (medical reasons not to use) to chemotherapy or radiation therapy
Participation in other clinical trials within the last 30 days
Allergies to study medications

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Verified sites

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

Verified
Charite Universitaetsmedizin Berlin KöR
Berlin, Germany
Verified
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH
Ulm, Germany
Verified
Kliniken Essen-Mitte,Evangelische Huyssens-Stiftung
Essen, Germany

Trial locations

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Investigated drugs

Based on the provided trial information, which involves radiochemotherapy and chemotherapy for gastroesophageal junction adenocarcinoma, the treatments involved are: Chemotherapy - A treatment that uses powerful drugs to kill cancer cells or stop them from growing and dividing. This treatment is given to patients both before and after surgery (perioperative) to target cancer cells throughout the body. Radiochemotherapy - A combined treatment approach that uses both radiation therapy and chemotherapy together. The radiation therapy uses high-energy rays to target and kill cancer cells in specific areas, while chemotherapy drugs work throughout the body. This combination is given before surgery (neoadjuvant) to help shrink the tumor and make it easier to remove.

What is already known about the treatment

Since no specific medications are listed in the provided trial data, I cannot create medication descriptions in the requested format. The trial data only shows that this is a study comparing radiochemotherapy versus chemotherapy for gastroesophageal junction adenocarcinoma, but doesn't specify which medications are used. To provide accurate medication descriptions, I would need information about the specific drugs used in either the chemotherapy or radiochemotherapy protocols. If you can provide the names of the medications used in this clinical trial, I will be happy to create descriptions following your requested format: Medication Name – description in a single cohesive paragraph.

Investigated diseases

Adenocarcinoma of the gastroesophageal junction - A cancer that develops at the area where the esophagus meets the stomach. The disease begins when cells in the gastroesophageal junction start growing uncontrollably, forming a tumor that originates in the glandular tissue. It typically starts in the inner layer of the junction tissue and can grow outward through other layers. The condition is classified into three types (I-III) based on the exact location of the tumor in relation to the junction between the esophagus and stomach. As the disease progresses, the tumor can grow larger and potentially spread to nearby lymph nodes and tissues.