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

PHASE2CompletedINTERVENTIONAL
Enrollment

58

Participants

Timeline

Start Date

January 31, 2004

Primary Completion Date

January 31, 2016

Study Completion Date

January 31, 2016

Conditions
Stomach CancerGastric Cancer
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.

Trial Locations (1)

77030

University of Texas MD Anderson Cancer Center, Houston

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Sanofi-Synthelabo

INDUSTRY

lead

M.D. Anderson Cancer Center

OTHER