drugset / Trial / NCT00002883

Surgery With or Without Combination Chemotherapy in Treating Patients With Cancer of the Esophagus

NCT00002883 ↗

Phase 3 Completed 250 enrolled UNICANCER
RandomizedTreatment

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not known whether combining chemotherapy with surgery is more effective than surgery alone. PURPOSE: Randomized phase III trial to compare the effectiveness of surgery with or without combination chemotherapy in treating patients with cancer of the esophagus.

Timeline

Start
1996-10
Primary completion
2006-11
Completion
2010-08

Publications

  • Results Boige V, Pignon J, Saint-Aubert B, et al.: Final results of a randomized trial comparing preoperative 5-fluorouracil (F)/cisplatin (P) to surgery alone in adenocarcinoma of stomach and lower esophagus (ASLE): FNLCC ACCORD07-FFCD 9703 trial. [Abstract] J Clin Oncol 25 (Suppl 18): A-4510, 200s, 2007.
  • Results Ychou M, Pignon JP, Lasser P, et al.: Phase III preliminary results of preoperative fluorouracil (F) and cisplatin (P) versus surgery alone in adenocarcinoma of stomach and lower esophagus (ASLE): FNLCC 94012-FFCD 9703 trial. [Abstract] J Clin Oncol 24 (Suppl 18): A-4026, 2006.

Drugs

EvaluationDrugModalityDoseRoute
Subject Cisplatin Other / unclassified — —
Subject fluorouracil Small molecule — Intravenous