Study on Organ Preservation for Early Stage Esophageal Cancer Using Durvalumab and Chemoradiation for Patients Eligible for Surgery

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What is this study about?

The clinical trial is focused on studying a treatment for esophageal adenocarcinoma, a type of cancer that affects the esophagus, which is the tube connecting the throat to the stomach. This study is specifically for early-stage cases, known as T1-T2N0 esophageal adenocarcinoma, where the cancer has not spread to the lymph nodes. The treatment being tested combines durvalumab, an immunotherapy drug also known by its code name MEDI4736, with chemoradiation, which is a combination of chemotherapy and radiation therapy. The goal is to see if this combination can help preserve the esophagus and avoid the need for radical surgery.

Participants in the study will receive the treatment through an intravenous infusion, which means the medication is given directly into a vein. The study will also include other medications such as Leucovorin, Taxotere (docetaxel), medoxa (oxaliplatin), and 5-FU (fluorouracil), which are commonly used in chemotherapy. Some participants may receive a placebo, which is a substance with no active medication, to compare the effects of the treatment. The purpose of the study is to assess how effective this treatment is in avoiding surgery and reducing the risk of complications, as well as to monitor the response of the cancer to the treatment.

The study will take place over several months, with regular check-ups and evaluations to monitor the participants’ health and the progress of the treatment. The main focus will be on the rate of complete response, meaning the cancer is no longer detectable, at the time of endoscopic re-evaluation, which is a procedure that uses a camera to look inside the esophagus. The study will also look at the long-term effects of the treatment, including the rate of response after one, two, and three years, as well as any side effects or adverse events that may occur. Participants will be closely monitored to ensure their safety and well-being throughout the study.

1 joining the study

Upon joining the study, the patient will begin the treatment phase designed to assess the effectiveness of a combination of medications and therapies aimed at preserving the esophagus.

2 medication administration

The patient will receive a series of medications through intravenous infusion. These include durvalumab, calcium folinate pentahydrate, docetaxel, oxaliplatin, and fluorouracil.

Each medication is administered as a solution for infusion, which means it is delivered directly into the bloodstream through a vein.

3 treatment schedule

The treatment involves a combination of immunotherapy and chemoradiation. The specific schedule, including dosage and frequency, will be determined by the medical team based on the patient’s condition and response to treatment.

4 endoscopic re-evaluation

At the end of the core study treatment, an endoscopic re-evaluation will be conducted to assess the response to the treatment. This involves using a camera to examine the esophagus and determine the effectiveness of the therapy.

5 long-term follow-up

The patient will be monitored for up to three years after the start of treatment to evaluate the long-term effects and outcomes. This includes checking for any signs of tumor recurrence and assessing overall health and quality of life.

Who Can Join the Study?

The patient must have given written informed consent, which means they agree to participate in the study after being informed about it.
Female patients who can have children and male patients with female partners who can have children must agree to avoid pregnancy by not having sexual intercourse or using very effective birth control methods during the study and for a certain time after the study ends. Male patients should not donate sperm during this time. If a male patient has a pregnant partner, they must agree to avoid sexual intercourse or use a condom during the pregnancy.
The patient must weigh more than 30 kilograms (about 66 pounds).
The patient must have good blood, liver, and kidney function, as shown by specific medical tests. These tests include:
- Leukocytes (a type of white blood cell) must be at least 3,000 per microliter.
- Platelets (cells that help blood clot) must be at least 100,000 per microliter without needing a transfusion.
- Absolute neutrophil count (another type of white blood cell) must be at least 1,500 per microliter without special support.
- Hemoglobin (a protein in red blood cells) must be at least 90 grams per liter. Patients can receive a transfusion to meet this requirement.
- Bilirubin (a substance made by the liver) must be no more than 1.5 times the normal limit.
- Aspartate transaminase and alanine transaminase (liver enzymes) must be no more than 2.5 times the normal limit.
- Alkaline phosphatase (another enzyme) must be no more than 2.5 times the normal limit.
- Serum creatinine (a waste product in the blood) must be no more than 1.5 times the normal limit, or the glomerular filtration rate (a measure of kidney function) must be more than 45 mL/min.
- Serum albumin (a protein in the blood) must be at least 25 grams per liter.
- For patients not on blood thinners: INR or aPTT (tests for blood clotting) must be no more than 1.5 times the normal limit. For patients on blood thinners: they must be on a stable treatment plan.
The patient must not have a human immunodeficiency virus (HIV) infection. If they do have HIV, they can still participate if:
- Their CD4 count (a type of white blood cell) is at least 350 cells per microliter.
- Their viral load (amount of virus in the blood) is undetectable.
- They are not taking certain medications that interact with the study drugs.
- They are expected to live a long time if cancer were not present.
- They have been on a stable HIV treatment plan for at least 4 weeks and are willing to continue it.
- Their HIV is not resistant to multiple drugs.
- Their HIV treatment does not interact with the study drugs.
The patient must be willing and able to follow the study plan, including any planned surgery, according to the investigator’s judgment.
The patient must be at least 18 years old when they sign the consent form.
The patient must have been diagnosed with a specific type of esophageal cancer, called esophageal adenocarcinoma, which includes cancer at the gastroesophageal junction (where the esophagus meets the stomach). The cancer must be at a certain stage (cT2 N0 M0 or T1 N0 M0) and must be considered removable by surgery according to current guidelines.
The tumor must be tested for certain markers, like PD-L1 and MSI status, using local tests before joining the study. These tests help determine the characteristics of the tumor. A sample of the tumor must be available for further testing if needed.
The patient must not have received previous treatments like chemotherapy or targeted therapy for their cancer.
The patient must not have had a complete removal of an esophagogastric tumor before.
The patient must have an ECOG score of 0 or 1, which means they are fully active or have some symptoms but can still do light work.
The patient must have a life expectancy of at least 12 weeks.

Who Cannot Join the Study?

Patients with any other type of cancer besides the specific type being studied, which is T1-T2N0 esophageal adenocarcinoma.
Patients who have had previous treatment for this type of cancer, such as surgery, chemotherapy, or radiation therapy.
Patients with serious health conditions that could interfere with the study, such as severe heart or lung disease.
Patients who are pregnant or breastfeeding, as the treatment could affect the baby.
Patients who are unable to follow the study procedures or attend the required appointments.
Patients with allergies or reactions to the study medications or similar drugs.
Patients who are participating in another clinical trial at the same time.
Patients with a history of certain infections, like HIV or hepatitis, which could affect the study results.
Patients with a history of autoimmune diseases, where the immune system attacks the body, as the treatment could worsen these conditions.
Patients with a history of drug or alcohol abuse, which could interfere with the study.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Universitaetsmedizin Goettingen	Goettingen	Germany
Universitaetsklinikum Heidelberg AöR	Heidelberg	Germany

Other Sites

Site Name	City	Country
Krankenhaus Nordwest GmbH	Frankfurt	Germany
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)	Munich	Germany
HELIOS Klinikum Bad Saarow GmbH	Bad Saarow	Germany
Universitaetsklinikum Schleswig-Holstein AöR	Kiel	Germany
Klinikum Mutterhaus der Borromaeerinnen gGmbH	Trier	Germany
Leopoldina-Krankenhaus der Stadt Schweinfurt GmbH	Schweinfurt	Germany
Klinikum der Stadt Ludwigshafen am Rhein gGmbH	Ludwigshafen Am Rhein	Germany
St. Josef-Hospital	Bochum	Germany
Universitaetsklinikum Brandenburg an der Havel GmbH	Brandenburg An Der Havel	Germany
Klinikum St Marien Amberg	Amberg	Germany
Gesellschaft Zur Forderung Des Wissenschaftlich Medizinischen Erkenntnisgewinns In Der Hamatologie Und Oncologie	Munster	Germany
Klinikverbund Allgaeu gGmbH	Kempten (Allgau)	Germany
Klinikum Darmstadt GmbH	Darmstadt	Germany
Charite Universitaetsmedizin Berlin KöR	Berlin	Germany
Dr. Vehling-Kaiser MVZ GmbH	Landshut	Germany
Ksuvseidxsphl Ryyexrdvgg Gtlf	Reutlingen	Germany
Usdjifchbgnlytsvwynng Ezxrs Avs	Essen	Germany
Kfhfhcoqlhe Sje Jjlzffvxmshc Gbje	Bremen	Germany
Swf Abbu Hqwmnmdp	Herne	Germany
Pegdfmyl Wluhpbiul	Wolfsburg	Germany
Mgdqrnzilghyngusqppottqfzj Hrjdskyjuwrjeigr	Halle (Saale)	Germany
Ktvijvba Emykhttdbbhyyiuvanescgrt Hhevvgwjbinkkztsk	Essen	Germany

Trial status

Country	Status	Recruitment Start
Germany	Not recruiting	28.08.2023

Trial locations

Investigated drugs:

Durvalumab is an immunotherapy medication used in this trial. It works by helping the immune system recognize and attack cancer cells more effectively. In this study, it is combined with other treatments to see if it can help preserve the esophagus and avoid the need for surgery in patients with early-stage esophageal cancer.

Chemoradiation is a combination of chemotherapy and radiation therapy. Chemotherapy uses drugs to kill cancer cells or stop them from growing, while radiation therapy uses high-energy rays to target and destroy cancer cells. In this trial, chemoradiation is used alongside durvalumab to enhance the treatment’s effectiveness in treating esophageal cancer.

Investigated diseases:

Esophageal Adenocarcinoma – This is a type of cancer that forms in the tissue lining the esophagus, the tube that carries food from the throat to the stomach. It often begins in the cells of mucus-secreting glands in the esophagus and is most commonly found in the lower part of the esophagus near the stomach. The disease progresses as the cancer cells grow and invade deeper layers of the esophagus and potentially spread to nearby lymph nodes and other organs. Symptoms may include difficulty swallowing, chest pain, and weight loss. The progression can vary, with some cases remaining localized while others may spread to distant parts of the body.

Trial ID:

2024-512980-29-00

Protocol code:

PRESTO

NCT ID:

NCT05713838

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Organ Preservation for Early Stage Esophageal Cancer Using Durvalumab and Chemoradiation for Patients Eligible for Surgery

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?