mFOLFIRINOX Versus mFOLFOX With or Without Nivolumab for the Treatment of Advanced, Unresectable, or Metastatic HER2 Negative Esophageal, Gastroesophageal Junction, and Gastric Adenocarcinoma (NCT05677490)
Randomized Phase III Trial of mFOLFIRINOX vs. FOLFOX With Nivolumab for First-Line Treatment of Metastatic HER2- Gastroesophageal Adenocarcinoma
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: University of Alabama at Birmingham Cancer Center — Birmingham, Alabama
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (793 Sites)
Showing the first 25 of 793 sites.
- University of Alabama at Birmingham Cancer Center — Birmingham, Alabama
- Anchorage Associates in Radiation Medicine — Anchorage, Alaska
- Anchorage Radiation Therapy Center — Anchorage, Alaska
- Alaska Breast Care and Surgery LLC — Anchorage, Alaska
- Alaska Oncology and Hematology LLC — Anchorage, Alaska
- Alaska Women's Cancer Care — Anchorage, Alaska
- Anchorage Oncology Centre — Anchorage, Alaska
- Katmai Oncology Group — Anchorage, Alaska
- Providence Alaska Medical Center — Anchorage, Alaska
- Fairbanks Memorial Hospital — Fairbanks, Alaska
- Kingman Regional Medical Center — Kingman, Arizona
- Cancer Center at Saint Joseph's — Phoenix, Arizona
- Mercy Hospital Fort Smith — Fort Smith, Arkansas
- CARTI Cancer Center — Little Rock, Arkansas
- Kaiser Permanente-Deer Valley Medical Center — Antioch, California
- Mission Hope Medical Oncology - Arroyo Grande — Arroyo Grande, California
- PCR Oncology — Arroyo Grande, California
- Sutter Auburn Faith Hospital — Auburn, California
- Sutter Cancer Centers Radiation Oncology Services-Auburn — Auburn, California
- Alta Bates Summit Medical Center-Herrick Campus — Berkeley, California
- Providence Saint Joseph Medical Center/Disney Family Cancer Center — Burbank, California
- Mills-Peninsula Medical Center — Burlingame, California
- Sutter Cancer Centers Radiation Oncology Services-Cameron Park — Cameron Park, California
- Mercy Cancer Center - Carmichael — Carmichael, California
- Mercy San Juan Medical Center — Carmichael, California
📞 Contact the Study Coordinator
Phone: (773) 834-9613
Email: aishwaryav@bsd.uchicago.edu
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Advanced Esophageal Adenocarcinoma
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- Adding Nivolumab to Usual Treatment for People With Advanced Stomach or Esophageal Cancer, PARAMUNE Trial — Little Rock, Arkansas
Explore by condition: All Advanced Esophageal Adenocarcinoma clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.