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

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What is this study about?

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.

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

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

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

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

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

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 Study?

  • 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 Study?

  • 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

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
University Hospital Jena KöR Jena Germany
Universitaet Leipzig Leipzig Germany

Other Sites

Site Name City Country Status
Krankenhaus Nordwest GmbH Frankfurt Germany
Klinikum Nuernberg Nürnberg Germany
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum) Munich Germany
Klinikum Dortmund gGmbH Dortmund Germany
Barmherzige Brueder Trier gGmbH Trier Germany
Universitaetsklinikum Aachen AöR Aachen Germany
Universitaetsklinikum Schleswig-Holstein AöR Kiel Germany
St. Josef-Hospital Bochum Germany
Johannes Wesling Klinikum Minden Minden Germany
Studienzentrum Onkologie Ravensburg GmbH Ravensburg Germany
Klinikum Magdeburg gGmbH Magdeburg Germany
Barmherzige Brueder gemeinnuetzige Krankenhaus GmbH Regensburg Germany
Klinikverbund Allgaeu gGmbH Kempten (Allgau) Germany
Pi.Tri Studien GmbH Offenburg Germany
Romed Klinikum Rosenheim Rosenheim Germany
Universitaetsklinikum Regensburg AöR Regensburg Germany
Charite Universitaetsmedizin Berlin KöR Berlin Germany
Philipps-Universitaet Marburg Marburg Germany
Universitaetsklinikum Mannheim GmbH Mannheim Germany
Rheinische Friedrich-Wilhelms-Universitaet Bonn Bonn Germany
Medical Center – University Of Freiburg Freiburg Im Breisgau Germany
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH Ulm Germany
Knlvjgcrudg Homimxrgkbscgeyahck Ojablvpesmka gambh Bielefeld Germany
Spr Aijf Hkwtxhlh Herne Germany
Pmpnseer Wvphjtkuj Wolfsburg Germany
Ulyzzpyvmyswwrcroqydi Wytqiscnc Agw Wuerzburg Germany
Maakxdxvwemmrogekfxxkouimi Hvvznpbahjifufjb Halle (Saale) Germany
Kufhtspf Eobqmllhlibklnabdichqveh Hgmpoenlzikeynvlz Essen Germany

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Germany Germany
Not recruiting
05.06.2020

Trial locations

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.

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.

Trial ID:
2024-516271-32-00
Protocol code:
RACE
NCT ID:
NCT04375605
Trial Phase:
Therapeutic confirmatory (Phase III)

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