NCT03279237

A Pilot Study of FOLFIRINOX in Combination With Neoadjuvant Radiation for Gastric and GE Junction Cancers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This research study is studying a combination of interventions as a possible treatment for gastroesophageal (GE) junction cancer. The interventions involved in this study are: -FOLFIRINOX which is made up of 4 different drugs: * 5-Fluorouracil (5-FU) * Oxaliplatin * Irinotecan * Leucovorin * Paclitaxel * Carboplatin * Proton Beam Radiation Therapy

Detailed description

This research study is a Pilot Study, which is the first time investigators are examining this study intervention. In this research study, the investigators are studying the combination of FOLFIRINOX followed by radiation with paclitaxel and carboplatin before surgery. The investigators believe that this intervention may help decrease the growth and spread of the cancer cells. FOLFIRINOX has shown to be very effective in patients whom disease has spread. The investigators are evaluating this regimen to see if there is an increase in curability when the cancer has not spread. The FDA (the U.S. Food and Drug Administration) has approved FOLFIRINOX as a treatment option for this disease. The FDA has not approved Paclitaxel or Carboplatin for this specific disease but they have both been approved for other uses. FOLFIRINOX is a combination of 4 chemotherapy agents that may help shrink the tumor before surgery. Carboplatin may stop the cancer cells from growing and paclitaxel may stop the cancer cells from growing and spreading

Conditions

• GastroEsophageal Cancer

Interventions

Type	Name	Description
DRUG	Irinotecan	May help shrink tumor before surgery.
DRUG	Oxaliplatin	May help shrink tumor before surgery.
DRUG	Leucovorin	May help shrink tumor before surgery.
DRUG	5-Fluorouracil	May help shrink tumor before surgery.
DRUG	Paclitaxel	Paclitaxel may stop cancer cells from growing and spreading.
RADIATION	Radiation Therapy	May help shrink tumor.
DRUG	Carboplatin	Carboplatin may stop cancer cells from growing.

Timeline

• Start date: 2017-10-24
• Primary completion: 2018-09-26
• Completion: 2024-02-29
• First posted: 2017-09-12
• Last updated: 2025-11-25
• Results posted: 2020-05-07

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study