RecruitingPhase 4NCT02366819

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

Sponsor

University of Chicago

Enrollment

36 participants

Start Date

Dec 11, 2014

Study Type

INTERVENTIONAL

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

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is studying whether using a patient's genetic makeup — specifically a gene that affects how the body breaks down a chemotherapy drug called irinotecan — can help doctors dose the drug more accurately to improve safety and effectiveness in treating stomach or esophageal cancer. **You may be eligible if...** - You have been confirmed to have locally advanced cancer of the stomach or the junction between the esophagus and stomach (gastroesophageal adenocarcinoma) - Your cancer has not spread to distant organs (no metastases) - You are planned to receive the mFOLFIRINOX chemotherapy regimen (a combination of several drugs) - You are 18 or older with adequate organ function **You may NOT be eligible if...** - You have cancer that has already spread to distant parts of the body - You have serious heart, kidney, or liver problems preventing chemotherapy - You are pregnant or breastfeeding - You cannot undergo the required diagnostic procedures Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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