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mFOLFIRINOX Versus mFOLFOX With or Without Nivolumab for the Treatment of Advanced, Unresectable, or Metastatic HER2 Negative Esophageal, Gastroesophageal Junction, and Gastric Adenocarcinoma
NCT05677490 · View on ClinicalTrials.gov ↗
Study Summary
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. Chemotherapy drugs work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Fluorouracil stops cells from making DNA and it may kill tumor cells. Leucovorin is used with fluorouracil to enhance the effects of the drug. Oxaliplatin works by killing, stopping, or slowing the growth of tumor cells. Some patients also receive an immunotherapy drug, nivolumab, in addition to FOLFOX chemotherapy. Immunotherapy may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. Irinotecan blocks certain enzymes needed for cell division and DNA repair, and it may kill tumor cells. Adding irinotecan to the FOLFOX regimen could shrink the cancer and extend the life of patients with advanced gastroesophageal cancers.
Conditions Studied
Interventions
- DRUG Fluorouracil
- DRUG Oxaliplatin
- BIOLOGICAL Nivolumab
- DRUG Irinotecan
- DRUG Leucovorin Calcium
Study Locations (20)
Alaska
- Anchorage Associates in Radiation Medicine — Anchorage
- Anchorage Radiation Therapy Center — Anchorage
- Alaska Breast Care and Surgery LLC — Anchorage
- Alaska Oncology and Hematology LLC — Anchorage
- Alaska Women's Cancer Care — Anchorage
- Anchorage Oncology Centre — Anchorage
- Katmai Oncology Group — Anchorage
- Providence Alaska Medical Center — Anchorage
- Fairbanks Memorial Hospital — Fairbanks
California
- Kaiser Permanente-Deer Valley Medical Center — Antioch
- Mission Hope Medical Oncology - Arroyo Grande — Arroyo Grande
- PCR Oncology — Arroyo Grande
- Sutter Auburn Faith Hospital — Auburn
- Sutter Cancer Centers Radiation Oncology Services-Auburn — Auburn
- Alta Bates Summit Medical Center-Herrick Campus — Berkeley
Arizona
- Kingman Regional Medical Center — Kingman
- Cancer Center at Saint Joseph's — Phoenix
Arkansas
- Mercy Hospital Fort Smith — Fort Smith
- CARTI Cancer Center — Little Rock
Alabama
- University of Alabama at Birmingham Cancer Center — Birmingham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 382 participants |
| Start Date | 2023-01-31 |
| Est. Completion | 2028-11-08 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05677490
The ClinicalTrials.gov registry entry for NCT05677490 describes a study currently listed as recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 382 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Alliance for Clinical Trials in Oncology, which has 147 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 10 conditions, with Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8 appearing as the primary indexed condition, and to 5 interventions — of which Fluorouracil is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05677490 reports 20 study locations spanning 5 distinct geographic areas — top geographies include Alaska, California, Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05677490 about?
NCT05677490 is a clinical study titled "mFOLFIRINOX Versus mFOLFOX With or Without Nivolumab for the Treatment of Advanced, Unresectable, or Metastatic HER2 Negative Esophageal, Gastroesophageal Junction, and Gastric Adenocarcinoma". 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, gastroesophage...
What is the current status of trial NCT05677490?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 382 participants. The study started on 2023-01-31. Estimated completion is 2028-11-08.
What conditions does trial NCT05677490 study?
This clinical trial studies the following conditions: Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8, Clinical Stage IV Gastric Cancer AJCC v8, Clinical Stage III Gastric Cancer AJCC v8, Clinical Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8, Clinical Stage III Esophageal Adenocarcinoma AJCC v8. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05677490?
The interventions under investigation include: Fluorouracil (DRUG), Oxaliplatin (DRUG), Nivolumab (BIOLOGICAL), Irinotecan (DRUG), Leucovorin Calcium (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05677490?
This trial is sponsored by Alliance for Clinical Trials in Oncology, which has 147 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05677490 being conducted?
This trial has 20 study locations across Alabama, Alaska, Arizona, Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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