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Compares treatment options for Advanced Esophageal Adenocarcinoma
Official title mFOLFIRINOX Versus mFOLFOX With or Without Nivolumab for the Treatment of Advanced, Unresectable, or Metastatic HER2 Negative Esophageal, Gastroesophageal Junction, and Gastric Adenocarcinoma
ClinicalTrials.gov ID: NCT05677490
What this study is testing
What is Fluorouracil?
Fluorouracil is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for advanced esophageal adenocarcinoma.
Also referred to as 2,4-Dioxo-5-fluoropyrimidine, 5 Fluorouracil.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This phase III trial compares the effect of modified fluorouracil, leucovorin calcium, oxaliplatin, and irinotecan (mFOLFIRINOX) to modified fluorouracil, leucovorin calcium, and oxaliplatin (mFOLFOX) for the treatment of advanced, unresectable, or metastatic HER2 negative esophageal, gastroesophageal junction, and gastric adenocarcinoma. The usual approach for patients is treatment with FOLFOX chemotherapy.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Histologic documentation: HER2 negative adenocarcinoma as defined by American Society of Clinical Oncology (ASCO) College of American Pathologists...
- Stage: unresectable or metastatic
- Tumor site: esophagus, gastroesophageal junction, or stomach
- Measurable disease or non-measurable but evaluable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
- No prior treatment for unresectable or metastatic disease
You likely can't join if
- Not pregnant and not nursing, because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects \ Therefore, for women...
- No known Gilbert's syndrome or known homozygosity for UGAT1A1\ 28 polymorphism
- No baseline grade \>= 2 peripheral neuropathy, neurosensory toxicity, or neuromotor toxicity per CTCAE version (v) 5.0 regardless of causality
- No medical condition such as uncontrolled infection or uncontrolled diabetes mellitus which, in the opinion of the treating physician, would make...
- No untreated, symptomatic brain metastasis. Patients with treated brain metastases are eligible if the following criteria are met: 1) follow-up brain...
- No allogeneic tissue/organ transplant
See the full eligibility criteria
- Histologic documentation: HER2 negative adenocarcinoma as defined by American Society of Clinical Oncology (ASCO) College of American Pathologists (CAP) guidelines (Bartley et al., Journal of Clinical Oncology [JCO]...
- Stage: unresectable or metastatic
- Tumor site: esophagus, gastroesophageal junction, or stomach
- Measurable disease or non-measurable but evaluable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
- No prior treatment for unresectable or metastatic disease
- Prior neoadjuvant or adjuvant cytotoxic chemotherapy or adjuvant immunotherapy is allowed as long as it was completed at least 1 year prior to registration
- Age \>= 18 years
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1
- Absolute neutrophil count (ANC) \>= 1,500/mm\^3
- Platelet count \>= 100,000/mm\^3
- Creatinine =\ = 30 mL/min
- Total bilirubin =\< 1.5 x ULN
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\< 3 x ULN (in patients with liver metastasis: =\< 5 x ULN if clearly attributable to liver metastases)
- Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or how well it works assessment of the investigational regimen are eligible for...
- Patients positive for human immunodeficiency virus (HIV) are eligible only if they meet all of the following:
- On effective anti-retroviral therapy
- Undetectable HIV viral load by standard clinical assay =\< 6 months of registration
- Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association...
- Patients who will receive nivolumab in addition to chemotherapy must not have any contraindications to immune checkpoint inhibitors
- Patients must not have active autoimmune disease that has required systemic treatment within 6 months prior to registration. Patients are permitted to receive immunotherapy if they have vitiligo, type I diabetes...
- Patients must not have a condition requiring systemic treatment with either corticosteroids (\>10mg/day prednisone equivalents) or other immunosuppressive medications within 14 days prior to registration. Inhaled or...
- Patients must not have a history of noninfectious pneumonitis requiring steroids
- Patients with prior immune mediated adverse events related to immunotherapy that resulted in permanent treatment discontinuation with these agents are ineligible
- This study includes the use of the mandatory patient completed measure, PRO-CTCAE. For this study the PRO-CTCAE is available in English, Spanish, Korean, Chinese (Simplified), and Russian, hence patients must be able to...
- Not pregnant and not nursing, because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects \ Therefore, for women of childbearing potential only, a negative serum or urine pregnancy...
- No known Gilbert's syndrome or known homozygosity for UGAT1A1\ 28 polymorphism
- No baseline grade \>= 2 peripheral neuropathy, neurosensory toxicity, or neuromotor toxicity per CTCAE version (v) 5.0 regardless of causality
- No medical condition such as uncontrolled infection or uncontrolled diabetes mellitus which, in the opinion of the treating physician, would make this protocol unreasonably hazardous for the patient
- No untreated, symptomatic brain metastasis. Patients with treated brain metastases are eligible if the following criteria are met: 1) follow-up brain imaging done at least in 4 weeks after central nervous system...
- No allogeneic tissue/organ transplant
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Anchorage, Alaska, United States
- Fairbanks, Alaska, United States
- Kingman, Arizona, United States
- Phoenix, Arizona, United States
- Fort Smith, Arkansas, United States
- Little Rock, Arkansas, United States
- Antioch, California, United States
- Arroyo Grande, California, United States
- Auburn, California, United States
- Berkeley, California, United States
- Burbank, California, United States
- Burlingame, California, United States
- Cameron Park, California, United States
- Carmichael, California, United States
- Castro Valley, California, United States
- Costa Mesa, California, United States
- Davis, California, United States
- Dublin, California, United States
- Elk Grove, California, United States
+ 491 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Anchorage, Alaska, United States; Fairbanks, Alaska, United States; Kingman, Arizona, United States; Phoenix, Arizona, United States; Fort Smith, Arkansas, United States and 505 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.