Participant flow

Preoperative Chemo and Chemoradiotherapy for Adenocarcinoma of the Stomach and Gastroesophageal Junction (GEJ) · Source last updated 2020-02-10

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

groups

1. description

   PreOp Chemotherapy: 2 cycles (each cycle consisting of 4 weeks or 2 treatments) of chemotherapy with oxaliplatin, folinic acid and infusional 5-FU (FOLFOX-48). Oxaliplatin 100 mg/m\^2 over 2 hours on day 1, folinic acid intravenous (IV) at 200 mg/m\^2 over 30 minutes on day 1, and 5-FU 2,200 mg/m\^2 over 48 hours as continuous infusion by outpatient pump starting on day 1. This therapy, FOLFOX-48 repeated every 2 weeks x 4 (8 weeks of induction chemotherapy). PreOp Chemoradiotherapy begins 12 days after last dose of PreOp Chemo 5FU plus oxaliplatin; A total of 45 Gy (1.8 Gy fx/d) of radiotherapy concurrent to low-dose continuous infusion of 5-FU (300 mg/m\^2/d Monday through Friday) \& weekly oxaliplatin 45 mg/m\^2 over 2 hours for 5 weeks (oxaliplatin administered on the first day of radiation week). Surgical resection 4-6 weeks after completion of chemoradiotherapy

   id

   FG000

   title

   5-Fluorouracil + Folinic Acid + Oxaliplatin

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         1

      type

      Withdrawal by Subject

   2. reasons

      1. group Id

         FG000

         num Subjects

         1

      type

      Lack of Efficacy

   3. reasons

      1. group Id

         FG000

         num Subjects

         1

      type

      Physician Decision

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         58

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         55

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         3

      type

      NOT COMPLETED

   title

   Overall Study

recruitment Details

Recruitment Period: January 13, 2004 to October 25, 2010. All recruitment done at The University of Texas MD Anderson Cancer Center.

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Preserved source evidence · Not medical advice