NCT02366819

Genetic Analysis-Guided Irinotecan Hydrochloride Dosing of mFOLFIRINOX in Treating Patients With Locally Advanced Gastroesophageal or Stomach Cancer

PERIOP-FOLFIRINOX: A Pilot Trial of Perioperative Genotype-guided Irinotecan Dosing of gFOLFIRINOX for Locally Advanced Gastroesophageal Adenocarcinoma

• Status: Suspended
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: University of Chicago · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This pilot clinical trial studies genetic analysis-guided irontecan hydrochloride dosing of modified fluorouracil, irinotecan hydrochloride, leucovorin calcium, oxaliplatin (mFOLFIRINOX) in treating patients with gastroesophageal or stomach cancer that has spread from where it started to nearby tissue or lymph nodes. Drugs used in chemotherapy, such as fluorouracil, irinotecan hydrochloride, leucovorin calcium, and oxaliplatin, 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. Leucovorin calcium may also help fluorouracil work better. Genetic analysis may help doctors determine what dose of irinotecan hydrochloride patients can tolerate.

Detailed description

PRIMARY OBJECTIVES: I. To determine the residual tumor (R) 0 resection rate. II. To determine the pathologic complete response (pCR) rate of up to 36 patients treated with 4 cycles of neoadjuvant mFOLFIRINOX (UGTA1A1 genotype-dosed irinotecan \[irinotecan hydrochloride\]) regimen. SECONDARY OBJECTIVES: I. Response rate (radiographic \[computed tomography (CT)\], and metabolic (positron emission tomography \[PET\] maximum standardized uptake value \[SUVmax\]) to chemotherapy. II. Chemotherapy-related toxicity. III. Surgical morbidity. IV. Overall survival (OS) measured from the time of histologic diagnosis. V. Disease-free survival measured from the time of histologic diagnosis. VI. Pattern of recurrence (distant, locoregional, both). VII. Human epidermal growth factor receptor 2 positive (HER2+) vs HER2 negative (-) difference in clinical outcomes. OUTLINE: PREOPERATIVE THERAPY: Patients receive oxaliplatin intravenously (IV) over 2 hours, leucovorin calcium IV over 2 hours, irinotecan hydrochloride IV over 90 minutes, and fluorouracil IV over 46 hours continuously on day 1. Courses repeat every 2 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. SURGERY: Patients undergo surgery. POST-OPERATIVE THERAPY: Beginning 5-10 weeks after surgery, patients receive oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, irinotecan hydrochloride IV over 90 minutes, and fluorouracil IV over 46 hours continuously on day 1. Courses repeat every 2 weeks for 4 more courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months for 3 years.

Conditions

• Esophageal Adenocarcinoma
• Gastric Adenocarcinoma
• Stage IIB Gastric Cancer
• Stage IIIA Esophageal Adenocarcinoma
• Stage IIIA Gastric Cancer
• Stage IIIB Esophageal Adenocarcinoma
• Stage IIIB Gastric Cancer
• Stage IIIC Esophageal Adenocarcinoma
• Stage IIIC Gastric Cancer

Interventions

Type	Name	Description
DRUG	Oxaliplatin	Given IV
DRUG	Leucovorin Calcium	Given IV
DRUG	Irinotecan Hydrochloride	Given IV
DRUG	Fluorouracil	Given IV
PROCEDURE	Conventional Surgery	Undergo surgery

Timeline

• Start date: 2014-12-11
• Primary completion: 2026-06-08
• Completion: 2026-06-08
• First posted: 2015-02-19
• Last updated: 2026-03-30

Locations

3 sites across 1 country: United States