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A Phase II Trial of Pre- and Postoperative Chemoradiotherapy and ZD1839 (IRESSA) Followed by Maintenance ZD1839 in Patients With Locoregionally Advanced Esophageal and Gastroesophageal Junction Carcinoma
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as cisplatin and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Cisplatin and fluorouracil may also make tumor cells more sensitive to radiation therapy. Gefitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving radiation therapy together with combination therapy and gefitinib before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving these treatments after surgery may kill any tumor cells that remain after surgery. PURPOSE: This phase II trial is studying how well giving radiation therapy together with combination chemotherapy and gefitinib before and after surgery works in treating patients with advanced esophageal or gastroesophageal junction cancer.
Details
| Lead sponsor | Case Comprehensive Cancer Center |
|---|---|
| Phase | Phase 2 |
| Status | COMPLETED |
| Enrolment | 80 |
| Start date | 2005-10 |
| Completion | 2010-02 |
Conditions
- Esophageal Cancer
Interventions
- cisplatin
- fluorouracil
- Iressa
- conventional surgery
- radiation therapy
Primary outcomes
- Survival at 1 year — 1 year
Survival at 1 year - Distant metastatic control at 1 year — 1 year
Distant metastatic control at 1 year
Countries
United States