drugset / Trial / NCT00193141
Chemotherapy With or Without Surgical Resection in Locally Advanced Esophageal Cancer
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Carboplatin | Small molecule | — | — |
| Subject | Paclitaxel | Small molecule | — | — |
| Background | fluorouracil | Small molecule | — | — |