Study on Durvalumab and FLOT Chemotherapy for Treatable Stomach and Gastroesophageal Cancer
Sponsor: AstraZeneca
ClinicalTrials ID:NCT04592913
This clinical trial is exploring whether a combination of the drug Durvalumab and FLOT chemotherapy, given before and after surgery, is safe and effective for patients with stomach or gastroesophageal cancer that can be removed by surgery.
Patient Parameters
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Program Overview
The purpose of this study is to test if using Durvalumab, a type of immunotherapy, along with FLOT chemotherapy (a mix of four drugs: flurouroacil, leucovorin, oxaliplatin, and docetaxel) before and after surgery can help treat stomach and gastroesophageal cancer that can be surgically removed. The study also aims to learn more about the cancer and related health issues.
Description
This study is investigating a treatment approach for patients with stomach or gastroesophageal cancer that can be removed by surgery. The treatment involves using Durvalumab, an immunotherapy drug, or a placebo, combined with FLOT chemotherapy both before surgery (to shrink the tumor) and after surgery (to eliminate any remaining cancer cells). The goal is to see if this combination is safe and effective in treating the cancer and to gain a better understanding of the disease and its associated health problems.
Eligibility Criteria
Inclusion Criteria
- Have a confirmed diagnosis of stomach or gastroesophageal junction cancer that can be surgically removed (Stage II or higher).
- Must be able to undergo major surgery to remove the cancer.
- Have not received any previous treatment for this cancer.
- Be in good overall health, with a performance status score of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
- Have adequate organ and bone marrow function as determined by medical tests.
- Provide a tumor sample before starting the study.
- Have a life expectancy of at least 24 weeks.
Exclusion Criteria
- Have cancer that has spread to the lining of the abdomen or to distant parts of the body.
- Have certain types of cancer, such as adenosquamous cell carcinoma, squamous cell carcinoma, or gastrointestinal stromal tumor.
- Have used immunosuppressive medications within 14 days before starting Durvalumab.
- Have any medical conditions that prevent the use of the study drugs.
- Have a history of organ transplantation from another person.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Research Site | 91010 | Duarte | California |
| Research Site | 90027 | Los Angeles | California |
| Research Site | 90095 | Los Angeles | California |
| Research Site | 91342 | Sylmar | California |
| Research Site | 33705 | St. Petersburg | Florida |
| Research Site | 32308 | Tallahassee | Florida |
| Research Site | 33401 | West Palm Beach | Florida |
| Research Site | 46804 | Fort Wayne | Indiana |
| Research Site | 40217 | Louisville | Kentucky |
| Research Site | 02215 | Boston | Massachusetts |
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