CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 58 enrolled
Drug / intervention
5-Fluorouracil +4 moredrug
Likely dose
5-Fluorouracil 300 mg/m2from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00525785
NCT00525785Phase 2Completed

A Phase II Trial of Preoperative Chemotherapy and Chemoradiotherapy for Potentially Resectable Adenocarcinoma of the Stomach and Gastroesophageal Junction

M.D. Anderson Cancer Center·interventional·Posted Sep 6, 2007·Updated Feb 10, 2020

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

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsSanofi-Synthelabo

Timeline

Phase 2CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 6, 2007
Enrollment StartJan 1, 2004
Primary CompletionJan 1, 2016
TodayJul 2, 2026
Enrollment to primary: 12 yearsPosted 18.8 years ago

Interventions

5-Fluorouracildrug

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.

Folinic Aciddrug

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

Oxaliplatindrug

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).

Radiotherapyradiation

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.

Surgeryprocedure

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