Not medical advice. This website is not medical advice, a diagnosis, a match to a trial, or a recommendation to join a study. Listings are plain-English rewrites of public ClinicalTrials.gov records. Whether a site is still enrolling, and whether you qualify, can only be confirmed by the study team and your clinician. Source registry: ClinicalTrials.gov. Editorial rules: methodology.
PlainTrials
RecruitingPhase 3interventionalRules rewrite

Phase 3: testing Fluorouracil for Advanced Esophageal Adenocarcinoma

This phase III trial compares the effect of modified fluorouracil, leucovorin calcium, oxaliplatin, and irinotecan (mFOLFIRINOX) with or without nivolumab to the effect of modified fluorouracil, leucovorin calcium, and oxaliplatin (mFOLFOX) with or without nivolumab for the treatment of patients with advanced, unresectable, or metastatic HER2 negative esophageal, gastroesophageal junction, or gastric adenocarcinoma. The usual approach for patients who are not in a study is treatment with FOLFOX with some receiving an immunotherapy drug, either nivolumab or pembrolizumab, in addition to FOLFOX chemotherapy.

Official registry: https://clinicaltrials.gov/study/NCT05677490 · Alliance for Clinical Trials in Oncology · enrollment listed as 382

What this phase means

Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are Fluorouracil, Leucovorin Calcium, or Oxaliplatin. The registry lists allocation as randomized. This phase III trial compares the effect of modified fluorouracil, leucovorin calcium, oxaliplatin, and irinotecan (mFOLFIRINOX) with or without nivolumab to the effect of modified fluorouracil, leucovorin calcium, and oxaliplatin (mFOLFOX) with or without nivolumab for the treatment of patients with advanced, unresectable, or metastatic HER2 negative esophageal, gastroesophageal junction, or gastric adenocarcinoma.

They plan to enroll about 382 people at 802 sites. Taking part typically means taking a study drug (or dummy pill), an infusion or injection of a biologic, a procedure as part of the study plus check-ins.

Official title (unrewritten)

Randomized Phase III Trial of mFOLFIRINOX vs. FOLFOX With Nivolumab for First-Line Treatment of Metastatic HER2- Gastroesophageal Adenocarcinoma

Interventions: Fluorouracil, Leucovorin Calcium, Oxaliplatin, Irinotecan, Nivolumab, Magnetic Resonance Imaging, Computed Tomography, Biospecimen Collection, Questionnaire Administration

Primary outcome (registry wording): Overall survival (OS)

Who it is for (from inclusion criteria)

  • Ages 18 Years to any
  • 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 systemic 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
  • 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 test done =\< 7 days prior to registration is required

Public study contact (from the registry)

Aishwarya Vijendran

773-834-9613

aishwaryav@bsd.uchicago.edu

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

802 listed

+ 7 sites outside the US on the same record

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FAQ about this NCT record

Is NCT05677490 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT05677490?

Phase 3. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT05677490?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary