MedTrace Logo

Preoperative Chemo and Chemoradiotherapy for Adenocarcinoma of the Stomach and Gastroesophageal Junction (GEJ)

NCT00525785 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 58

Last updated 2020-02-10

Study results available
· View outcomes & findings →

Summary

The goal of this clinical research study is to learn if a combination of 5-FU, Folinic Acid and Oxaliplatin, given with radiation therapy, is effective in the treatment of gastric or gastroesophageal cancers that will be removed by surgery if possible. The safety of this combination therapy will also be studied.

Conditions

Interventions

DRUG

5-Fluorouracil

2.2 Gm/m\^2 By Vein Over 48 Hours On Days 1, 15, 29, and 43. Chemoradiotherapy: 300 mg/m2 a day Monday through Friday, by continuous infusion during radiation through an outpatient portable pump.

DRUG

Folinic Acid

200 mg/m\^2 by vein Over 30 Minutes On Days 1, 15, 29, and 43.

DRUG

Oxaliplatin

100 mg/m\^2 By Vein Over 2 Hours On Days 1, 15, 29, and 43. Chemoradiotherapy: 45 mg/m\^2 over 2 hours weekly for 5 weeks during radiation. (oxaliplatin should be administered on the first day of the radiation week).

RADIATION

Radiotherapy

45 Gy (1.8 Gy fx/day) Monday through Friday, 12 days after the last dose of 5FU plus oxaliplatin and no later than 28 days.

PROCEDURE

Surgery

4-6 weeks after completion of chemoradiotherapy, restaged \& surgical resection of the primary tumor and lymph nodes attempted.

Sponsors & Collaborators

  • Sanofi-Synthelabo

    collaborator INDUSTRY

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Jaffer Ajani, MD · M.D. Anderson Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-01-31
Primary Completion
2016-01-31
Completion
2016-01-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00525785 on ClinicalTrials.gov