drugset / Trial / NCT00003118

Surgery With or Without Chemotherapy and Radiation Therapy in Treating Patients With Cancer of the Esophagus

NCT00003118 ↗

RandomizedParallel-groupOpen-labelTreatment

Summary

RATIONALE: Drugs used in chemotherapy use 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. It is not yet known whether surgery is more effective with or without chemotherapy and radiation therapy for cancer of the esophagus. PURPOSE: Randomized phase III trial to compare the effectiveness of surgery with or without combination chemotherapy and radiation therapy in treating patients who have cancer of the esophagus that can be surgically removed.

Timeline

Start
1997-10
Primary completion
2000-03
Completion
2000-03

Outcome

Met primary endpoint

paper An intent-to-treat analysis showed a median survival of 4.48 v 1.79 years in favor of trimodality therapy (exact stratified log-rank, P = .002). PMID 18309943 ↗

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject Cisplatin Other / unclassified 100 mg/m2 Intravenous
Subject fluorouracil Small molecule 1000 mg/m2 Intravenous

Indications