At a glance
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A Phase II Trial of Preoperative Chemotherapy and Chemoradiotherapy for Potentially Resectable Adenocarcinoma of the Stomach and Gastroesophageal Junction
In Brief
A Phase 2 clinical trial evaluating 5-Fluorouracil, Folinic Acid, and 3 other interventions for Stomach Cancer and Gastric Cancer. Completed, enrolled 58 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
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.
200 mg/m\^2 by vein Over 30 Minutes On Days 1, 15, 29, and 43.
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).
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.
4-6 weeks after completion of chemoradiotherapy, restaged \& surgical resection of the primary tumor and lymph nodes attempted.