CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 98 enrolled
Drug / intervention
fluorouracil +3 moredrug
Likely dose
Oxaliplatin 85 mg/m² IV infusion on days 1, 15, and 29; 5-Fluorouracil 180 mg/m²/day by 24-hour infusionAI-extracted
Key inclusion· 7
  • ✓Histologically confirmed primary adenocarcinoma of the thoracic esophagus or gastroesophageal junction
  • ✓Clinical stage II or III disease confirmed by CT/MRI with PET scan
  • ✓Primary esophageal tumor at least 20 cm below the incisors (with bronchoscopy/negative cytology if <26 cm)
  • ✓Esophageal disease confined to esophagus and peri-esophageal soft tissue, or gastroesophageal junction disease extending ≤2 cm into gastric cardia
Key exclusion· 6
  • ✕Recurrent esophageal cancer
  • ✕No other malignancy within past 5 years (except adequately treated skin cancer or cervical carcinoma in situ)
  • ✕Peripheral neuropathy grade 2 or higher
  • ✕Myocardial infarction or cerebrovascular event within past 6 months

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

Search/NCT00086996
NCT00086996Phase 2Completed
CompareCT.gov

Oxaliplatin (NSC-266046) Plus Protracted Infusion 5-Fluorouracil And Radiation For Potentially Curable Esophageal Cancer: A Phase II Trial With Molecular Correlates

SWOG Cancer Research Network·interventional·Posted Jul 12, 2004·Updated Oct 11, 2013

In Brief

A Phase 2 clinical trial evaluating fluorouracil, oxaliplatin, and 2 other interventions for Esophageal Cancer. Completed, enrolled 98 participants across 143 sites.

Detailed Summary

RATIONALE: Drugs used in chemotherapy, such as oxaliplatin and fluorouracil, work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Oxaliplatin and fluorouracil may make tumor cells more sensitive to radiation therapy and may kill more tumor cells. Giving chemotherapy and radiation therapy before surgery may shrink the tumor so that it can be removed. PURPOSE: This phase II trial is studying how well giving oxaliplatin together with fluorouracil and radiation therapy works in treating patients who are undergoing surgery for stage II or stage III cancer of the esophagus or gastroesophageal junction.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEsophageal Cancer
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI)

Timeline

Phase 2CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 12, 2004
Enrollment StartSep 1, 2004
Primary CompletionAug 1, 2009
Study CompletionAug 1, 2011
TodayJul 2, 2026
Enrollment to primary: 4.9 yearsPosted 22.0 years ago

Interventions

fluorouracildrug

Before surgery: 180 mg/m2/day by 24-hour infusion days 8 through 43. After surgery:180 mg/m2/day by 24-hour infusion days 1 through 36.

oxaliplatindrug

Before surgery: 85 mg/m2 by 2-hour IV infusion days 1, 15, and 29. After surgery: 85 mg/m2 by 2-hour IV infusion days 1, 15, and 29.

conventional surgeryprocedure

The surgical technique will depend upon the location and extent of tumor and individual surgeon preference.

radiation therapyradiation

Starting Day 8, patients will be treated 5 days/week at 180 centigray (cGy)/day times 25 fractions to a total dose of 4,500 cGy.