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

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Massachusetts General Hospital
Study ID
NCT03279237
Phase
PHASE1
Status
Completed

Conditions

  • GastroEsophageal Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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

Key Dates

Start date
Oct 24, 2017
Status verified
Apr 2026
Primary completion
Sep 26, 2018
Completion
Apr 1, 2026

Study Design

Enrollment
25 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: FOLFIRINOX + pre-operative radiation
    * FOLFIRINOX is a combination of 4 drugs that is administered twice per cycle * Oxaliplatin is administered intravenously * Leucovorin is administered intravenously * Irinotecan is administered intravenously * 5-Fluorouracil is administered intravenously * Paclitaxel and Carboplatin will be given concurrently with radiation therapy every 7 days

Primary Outcome Measure

The Completion Rate of Chemotherapy in Combination With Chemoradiation [ Time Frame: 21 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
Massachusetts General HospitalBostonMassachusetts02214-

Find similar trials in Boston, MA

By research site
Massachusetts General Hospital· Boston, MA

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