drugset / Trial / NCT00193141

Chemotherapy With or Without Surgical Resection in Locally Advanced Esophageal Cancer

NCT00193141 ↗

RandomizedParallel-groupOpen-labelTreatment

Summary

In this randomized study, we plan to address the important question of optimum local treatment for patients with localized esophageal cancer. All patients will receive our previously studied neo-adjuvant regimen including paclitaxel, carboplatin, infusional 5-FU, and radiation therapy to 45 Gy. At the completion of neo-adjuvant therapy, patients will be randomized to undergo surgical resection, or to continue radiation to a total dose of 60 Gy, along with one additional course of chemotherapy.

Timeline

Start
1999-10
Primary completion
2004-10
Completion
2007-07

Publications

  • Results Hainsworth JD, Meluch AA, Gray JR, Spigel DR, Meng C, Bearden JD, Hermann R, Greco FA. Concurrent chemoradiation followed by esophageal resection vs chemoradiation alone for localized esophageal cancer. Community Oncology 4:431-439, 2007.

Drugs

EvaluationDrugModalityDoseRoute
Subject Carboplatin Small molecule — —
Subject Paclitaxel Small molecule — —
Background fluorouracil Small molecule — —

Indications