Study on Durvalumab and FLOT Chemotherapy for Patients with Resectable Gastric and Gastroesophageal Cancer

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What is this study about?

This clinical trial is focused on studying treatments for patients with a type of cancer called gastric cancer or gastroesophageal junction cancer. These are cancers that occur in the stomach or where the stomach meets the esophagus. The study will explore the effects of a medication called Durvalumab, which is given as an infusion, meaning it is delivered directly into the bloodstream through a vein. Durvalumab is being tested in combination with a chemotherapy regimen known as FLOT, which includes the drugs Fluorouracil, Leucovorin (also known as Folinic Acid), Oxaliplatin, and Docetaxel. These drugs are used to kill cancer cells or stop them from growing. The study will also involve a placebo, which is a substance with no active medication, to compare the effects of the treatment.

The purpose of this study is to see if the combination of Durvalumab and FLOT chemotherapy, followed by additional Durvalumab treatment, can improve outcomes for patients with resectable gastric or gastroesophageal junction cancer. “Resectable” means that the cancer can be surgically removed. The study will be conducted in phases, starting with treatment before surgery (neoadjuvant) and continuing after surgery (adjuvant). Participants will be randomly assigned to receive either the active treatment or a placebo, and neither the participants nor the researchers will know who is receiving which treatment until the study is completed. This is known as a double-blind study.

The study will last for a period of up to 18 months, during which participants will receive the treatments and be monitored for their health and response to the treatment. The main goal is to assess event-free survival, which means the length of time participants live without the cancer getting worse or coming back. Secondary goals include overall survival and the rate of complete response to the treatment. This study aims to provide valuable information on the effectiveness of Durvalumab in combination with FLOT chemotherapy for treating gastric and gastroesophageal junction cancers.

1 joining the study

Upon joining the study, the patient is confirmed to have a type of cancer called gastric or gastroesophageal junction adenocarcinoma that can be surgically removed.

The patient must not have received any previous treatment for this cancer and should have a good performance status as per the World Health Organization (WHO) or Eastern Cooperative Oncology Group (ECOG) scale.

2 neoadjuvant treatment phase

The patient receives a combination of medications before surgery, known as neoadjuvant treatment. This includes durvalumab administered intravenously, and a chemotherapy regimen called FLOT, which consists of fluorouracil, folinic acid, oxaliplatin, and docetaxel, all given intravenously.

The purpose of this phase is to shrink the tumor before surgical removal.

3 surgery

The patient undergoes surgery to remove the cancerous tissue. This is a critical step in the treatment process.

4 adjuvant treatment phase

After surgery, the patient receives additional treatment to eliminate any remaining cancer cells. This is known as adjuvant treatment.

The patient continues to receive durvalumab intravenously to help prevent cancer recurrence.

5 follow-up and monitoring

The patient is regularly monitored to assess the effectiveness of the treatment and to check for any signs of cancer returning.

This phase includes regular medical check-ups and imaging tests as needed.

Who Can Join the Study?

Patients must have a confirmed diagnosis of gastric or gastroesophageal junction adenocarcinoma. This means the cancer is in the stomach or where the stomach meets the esophagus, and it has been confirmed by examining tissue under a microscope.
The disease must be resectable, meaning it can be removed by surgery, and it should be at Stage II or higher according to the AJCC 8th edition, which is a system used to describe the extent of cancer.
Patients must have undergone radical surgery, which is a type of surgery aimed at removing all cancerous tissue.
No previous anti-cancer therapy should have been received for the current cancer. This means the patient should not have had treatments like chemotherapy or radiation for this cancer before.
Patients should have a World Health Organization (WHO)/ECOG Performance Status of 0 or 1 at enrollment. This is a scale that measures how well a patient can perform daily activities, with 0 being fully active and 1 being restricted in physically strenuous activity but able to carry out light work.
Patients must have adequate organ and marrow function, meaning their organs and bone marrow are working well enough to handle the treatment.
A tumor sample must be available before entering the study. This is a piece of the cancer that has been removed and can be used for testing.
Patients must have a life expectancy of at least 24 weeks, meaning they are expected to live for at least 24 weeks.
Both male and female patients can participate.

Who Cannot Join the Study?

Patients with a type of stomach cancer called adenocarcinoma that is not at a stage where it can be surgically removed.
Patients with a type of cancer that is not located in the stomach or the area where the stomach meets the esophagus.
Patients who have a type of cancer that is not classified as Stage II or higher according to the AJCC 8th edition, which is a system used to describe the extent of cancer.
Patients who are not within the specified age range for the study.
Patients who are not part of the specified clinical trial groups.
Patients who are not male or female, as both genders are included in the study.
Patients who are considered part of a vulnerable population, which means they might need special protection or care.

Where you can join this trial?

Verified and Recommended Sites

Site Name	City	Country	Status
Wojskowy Instytut Medyczny Państwowy Instytut Badawczy	Warsaw	Poland

Verified Sites

Site Name	City	Country
University Hospital Jena KöR	Jena	Germany
Center For Pediatric And Adolescent Medicine Of The Johannes Gutenberg University Mainz	Mainz	Germany
Centre Hospitalier Regional Et Universitaire De Brest	Brest	France
Technische Universitaet Dresden	Dresden	Germany
Katholieke Universiteit te Leuven	Leuven	Belgium
Haematologisch Onkologische Praxis Eppendorf	Hamburg	Germany

Other Sites

Site Name	City	Country
Centre Antoine Lacassagne	Nice	France
Centre Hospitalier Universitaire De Nantes	Nantes	France
Hospital General Universitario Gregorio Maranon	Madrid	Spain
Hopital Beaujon	Clichy	France
Uniwersytecki Szpital Kliniczny W Poznaniu	Poznan	Poland
Institut Sainte Catherine	Avignon	France
Hcrxtpyb Vsof dvihsooq	Barcelona	Spain
Vuxppt dgb Rwfov Uhbgyiibqw Hffnojzz	Sevilla	Spain
Ogfzkf Urzhdwezin Hpawkjzw	Odense	Denmark
Utaxtpsaraiuigpkqjbaz Tyndclcwf Ami	Tuebingen	Germany
Cgowyye Uennunuswmgrbuzbzpfn Btemtz Kkb	Berlin	Germany
Sokkkhxsqcxq Hgrpfkvmp Gqlr	Heilbronn	Germany
Enfbpdu Ukjmwxfdmurj Mdnbbao Cmqakuk Rumqyywra (uyogrvx Mnj	Rotterdam	The Netherlands
Skrzhdlupix Pkqvqvfln Zyqsmd Ogixqp Zvoawyylne Sttzfiw Uqrzmlpnbyjvz W Klqmeuya	Cracow	Poland
Adrzuqn Uhpxbykndm Hhdxeddw	Aalborg	Denmark
Uemrxembenyoplxayfmmd Hgcoiejeba Alr	Heidelberg	Germany
Ctxzlm Hpgffnydmkv Uwkllcorincpf Dr Rgayjo	Rennes	France
Rdwcbyhvjtzrrn	Copenhagen	Denmark
Utfkfxmaeaaozd Cnitbpy Kftziwfoq	Gdansk	Poland
Hurjlyvg Dt Lj Sbzhf Cjps I Sdov Pxa	Barcelona	Spain
Cxwlto Lpjb Bqfppz	Lyon	France
Uphwdsqhfk Om Atznded	Edegem	Belgium
Kauftdcy dey Tpgtihfxuqi Uonrfaxqoyyx Mciiuisd (duo Kxamwvtyi	Munich	Germany
Uayxcofnlf Mvavvyp Cgvpyb Halyhorgyjtsxxesk	Hamburg	Germany
Hktymshw Uknvlrctfewie Mtvnfmj Ds Vlhlnbnrrv	Santander	Spain
Ikkrdmbw Cwwdjv Dvnvskwfbxuavvjkk	L'hospitalet De Llobregat	Spain
Asabnuhy Zmzcsynnke Dprmy	Roeselare	Belgium
Wyvfuwonwvl Wkphltsogqvnoxrjwocj Clcbrdg Orwlhxccy I Tufevzhtexaok Iu Mkfngumweqs W Lhjla	Lodz	Poland
Kvbwnfbvutu Nwebozpi Gjzh	Frankfurt	Germany
Iwtvqgjl Ryblcpqn Dq Cnybev Dw Menqgxgrwdj	Montpellier	France
Hjcyqxc Sekty Akunwpq	Paris	France
Txfos Vrbhptnbr Bmmtahr Jcrgl Kxrxfd	Szekszard	Hungary
Ooicfbay Ocdlmynbib Iqaklcx	Budapest	Hungary
Bmubqxpionz Vyjrbvuiv Opwcfjpskevh	Kecskemet	Hungary
Cjjnty Hnwszzoguad Uvpvxvergifoa Dc Dxajg	Dijon	France
Ajrholitlg Puddcqfg Hdvkyoyt Dp Puptq	Paris	France
Cakdbednt Zwhmmruyoz Spndwrvdt	Eindhoven	The Netherlands
Buspdoeu Uzsmvxegic Hibamijk Cscapw	Besançon	France
Gsvhvqqpyvzrjlexj Vdodaljqd Pqal Afmlop Ebyjdhnr Ooeevu Kgfwly	Gyor	Hungary
Ctf Muenxuhuv	Liege	Belgium
Nfkinbxa Ifsjpqgw Oqlhdxlhv Iyi Mepxr Saruhzfzvpgyilipcqaglsoqvbkm Iyyhbiam Bmknahzz	Cracow	Poland
Nzwatxrmjcl Cwwwxs Ixlmytpdm	Amsterdam	The Netherlands
Ldjbvvekcgenslllnrxznb ddh Swevi Sbfhrojlxqd Guev	Schweinfurt	Germany
Gfvua Hhlbtgn Da Cqogcmgtk	Charleroi	Belgium
Wpskiggtospnm Cbkmbjl Obaissiwy Iro Mrbjy Sbrcchrzglnnnzocog	Poznan	Poland
Jnpqfomxvnnytqopzjgv Vpflqwkzu Htxucqp Gvmb Kufwsrrgppqpvyodfdrns	Szolnok	Hungary
Bfwgghisfjoh Chdoinp Opjtidqlc Iis Mrqdt Ssrbcffbmzczggvkpz W Bwhkkoclcer	Bialystok	Poland

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	08.12.2023
Denmark	Not recruiting	08.12.2023
France	Not recruiting	08.12.2023
Germany	Not recruiting	08.12.2023
Hungary	Not recruiting	08.12.2023
Poland	Not recruiting	08.12.2023
Spain	Not recruiting	08.12.2023
The Netherlands	Not recruiting	08.12.2023

Trial locations

Investigated Drugs:

Durvalumab is a medication used in this clinical trial to help the body’s immune system fight cancer. It works by blocking a specific protein that can stop the immune system from attacking cancer cells. In this study, it is given to patients both before and after surgery to see if it can improve the chances of the cancer not coming back.

FLOT Chemotherapy is a combination of four different chemotherapy drugs used together to treat gastric and gastroesophageal junction cancer. This combination is used to shrink the tumor before surgery and to kill any remaining cancer cells after surgery. The goal is to improve the overall effectiveness of the treatment and increase the chances of a successful outcome.

Investigated Diseases:

Gastric Adenocarcinoma – This is a type of cancer that begins in the glandular cells of the stomach lining. It typically progresses by invading the stomach wall and can spread to nearby lymph nodes and other organs. The disease is often categorized by stages, with Stage II or higher indicating more advanced disease. Symptoms may include abdominal pain, weight loss, and nausea. The progression can vary, with some cases remaining localized while others spread more extensively. Early detection is crucial for managing the disease effectively.

Gastroesophageal Junction Adenocarcinoma – This cancer occurs where the esophagus meets the stomach, known as the gastroesophageal junction. It develops from the glandular cells in this area and can progress by invading surrounding tissues and spreading to other parts of the body. The disease is staged similarly to gastric adenocarcinoma, with higher stages indicating more extensive disease. Common symptoms include difficulty swallowing, chest pain, and unintended weight loss. The progression can lead to complications if not addressed in a timely manner. Understanding the stage of the disease is important for determining the appropriate management approach.

Trial ID:

2023-507338-26-00

Protocol code:

D910GC00001

NCT ID:

NCT04592913

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Durvalumab and FLOT Chemotherapy for Patients with Resectable Gastric and Gastroesophageal Cancer

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